Umang Project

M.Pharm. (PMRA) IV Sem.(2009-2010) Mid Term Report

4. WORK PERFORMED

4.1 TO STUDY THE REQUIREMENT OF PRODUCT LAUNCHING STRATEGY

The new product launch method gives a checklist of important activities for

launching new products. It specifies strategic and tactical activities in the

marketing area, which conducts in a strategic plan and a tactical plan. These

plans are a preparation for launching a new product.

The main requirements are as follows-

(a) Name of product:

The name of product is required at first step of launching. The name of product

can be selected by many methods such as, it can be

among words from generic name of drug.

similar to remaining brands of company.

similar to innovator brand of the drug.

selected from slogan of the launching product.

related to theme to the product.

from randomized method.

Ideal characteristic of name of product

It should be:

very catchy.

easy to write and understand.

easy to remember.

(b) Product summary

The product summary is also required before launching a product. The product

summary should be kept in mind while making strategy to launch a new product.

It should contain the following-

dosage form

strength

composition

storage condition

precaution, if any

indication

(c) Market Size

It should be kept in mind that how big the market is, in which the company is

entering. It comprises of total market size of ‘class of drug’ from which it belongs

and the total market size of the drug.

(d) Finding leading competitors

Lachoo Memorial College of Science and Technology, Pharmacy Wing, Jodhpur 1

M.Pharm (PMRA) IV Semester Mid Term Report, 2009-2010 Work Performed

Before making strategy for a new product launch, it is required to find about the

leading competitors. It should contain the following information of competitors-

name of the product

name of competitor company

composition of competitor’s product

dosage form and strengths available

packaging and price of product

cost of the treatment

indication in which they are promoting

policies of competitors

(e) Selection of doctors

It is required to select the group of doctors to whom the product will be promoted.

It depends upon the type of drug and type of practice of doctor. Broadly, it can be

classified as follows-

Specialties (physician, cardiologist, neurologist etc.).

General practitioners

Others.

(f) Visual aid

This is the most useful tool to communicate the message about the product to the

doctors. The message about the drug product should be easy to communicate

and easy to understand by doctors. The visual aid is usually carried out by

representative of that company. It should contain the following information-

The name of the product

The dosage form(s) and strength(s)

Indication (s)

Slogan of the product

Punch line of the product

Benefits of product over other brands and molecules

Price of the product

Clinical study, if any

Advantages of Visual Aids

Strengthen the clarity of the speaker’s message.

Increase the interest of the speaker’s information.

Make a speaker’s message easier for listeners to retain.

Enhance the speaker’s credibility.

Can improve the speaker’s persuasion.

Helps combat stage fright

(g) Input planning

Lachoo Memorial College of Science and Technology, Pharmacy Wing, Jodhpur | 2


Inputs are the helping tool for promoting a product. It should be related to theme

of the product so that it will help to remember the product, while writing a

prescription by a doctor. It can be of following types-

In form of any article.

In form of academic books, journal, magazine, newsletter etc.

In form of services.

(h) Feedback activity

Feedback activity plays an important role to improve the strategy. It is required

for product launching strategy.

4.2 TO FIND MARKET INFORMATION FOR LEVETIRACETAM DRUG

Before making product launching strategy, it is necessary to find market

information/data for Levetiracetam drug.

The importance of market information as a driving force and key factor to

success is significantly increasing. The challenge is to select the right information

at the right time to find answers and to map out strategies in a highly competitive

market.

The market information/data can be collect from two methods.

4.2.1. Secondary data16

The data already available are called secondary data. To avoid duplicating efforts,

running up unnecessary costs and tiring the informants, it is recommended

wherever possible to rely on existing information (secondary data) such as:

Published statistics: Census, housing and social security data, and so on

Published texts: Theoretical work, secondary analyses by ‘experts’ and reports

Media: Documentaries for example, as a source of information

Personal documents: Diaries

Case studies and literature Reviews.

For collecting the secondary data, the literature review has been done, case

studies have been carried out, published texts and statistic have been used,

and media (especially internet) and personal contacts have also been utilized.

Secondary data are also helpful in designing subsequent primary research and

can provide a baseline with which the collected primary data results can be

compared. Therefore, it is always wise to begin any research activity with a

review of the secondary data.

4.2.2. Primary data17



The data, which are to be collected, and which are not already available are called

primary data. The key point here is that the data collected are unique and until

published, no one else has access to it.

Methods for primary data collection

There are several methods for primary data collection, they are as follows-

Survey method.

Focus Groups/Interviews method.

Open Forums/Public Meetings

Observation/site visits.

Media Monitoring.

Criteria for selection of survey method

A survey is usually general and covers a wide range of issues. It is designed to find

information rather than to investigate specific questions about an issue. If

numerical system or yes/no answer system for survey is used than, it will be easy

to enter the results into a spreadsheet program such as Microsoft Excel. If the

survey is an open-ended question style, it should fit answers into categories of

responses. The policy makers tend to use surveys when they don't know about

something and they want to identify the most important ideas, questions and

issues.

The survey method is selected for finding primary data because it has the

following advantages-

Advantages of survey analysis

Scaleable.

Simplicity (easily collectable).

Low cost.

Collaborative (can use a proxy or another person to gather data).

Quickness.

Integrate able.

Flexibility (The researcher does not necessarily have to be involved in the data

collection process).

Place of survey:

In survey the place of survey has an important role. As this dissertation work

is on “PRODUCT LAUNCHING STRATEGY FOR LEVETIRACETAM ON BEHALF OF

PROMED GROUP FOR INDIAN MARKET” is being carried out at New Delhi.

Further this survey will be extrapolated to the national level. It will be

assumed that the finding from the New Delhi survey will be the same at the

national level also, as this survey will be mainly concentrated on finding the

competitor’s strategy for their Levetiracetam brand, which generally be

common across the country.



Nature of the sample:

The nature of the sample is essential for survey. As this dissertation work is

being carried out for new product launching, so those natures of samples has

been selected from where the new product has to move on.

For this, the doctor, wholesaler, chemist, (on the basis of convenience) for

survey. The professional status as well as the area of specialization of the

doctors differed.

Size of the sample:

The size of sample has to be defined. It is impossible to collect data from

every person, therefore samples are necessary. A sample population is a part

of the relevant population. It is assumed that results from a sample population

will hold good for the whole population.

As this survey is mainly carried out to collect the information about the

competitor’s strategy, which is generally common across the country, so

sample size doesn’t play an important role. The survey work for this

dissertation work, we have chosen the various neurologists from reputed

hospitals like AIIMS, GB Pant hospital, Max Healthcare, Fortis, RML Hospital,

Apollo Hospital, Sir Ganga Ram Hospital etc in Delhi which covers whole New

Delhi and it is assumed that the response will be similar from other hospital

too. For wholesalers and chemists we have chosen the chemists near by these

hospitals and we have received the list of wholesalers from these chemists

shop.

SIZE OF SAMPLE

S.No NATURE OF SAMPLE SIZE OF SAMPLE

1. Doctor 25

2. Wholesaler 15

3. Chemist 30

Preparation of covering letter & questionnaires:

To conduct survey, first the covering letter and questionnaires have been

prepared. The covering letter has been prepared for giving a brief introduction

about the dissertation topic to the persons who will fill the questionnaires.

For a questionnaire; the doctor, wholesaler, and chemist have been selected, as

through these channels the new product has to pass. So mainly to know the

competitor’s strategy at every channel, the questionnaires have been prepared

for them. While preparing each questionnaire, it was kept in mind that the only

those questions were placed in questionnaire which were helpful in making

product launching strategy.



A multiple choice and objective type questionnaire was formulated and distributed

to the doctors. The respondents had only to tick their response in the appropriate

place on the questionnaire in most questions. Some of the questions were open-

ended questions.

The covering letter and all questionnaires have been prepared on company’s

letterhead. All the questionnaires are as follows-



To, Date:

……….

……………………………………………………..

……………………………………………..………

Subject: Filling of a questionnaire

Sir/ Madam

Promed Group is a leading pharmaceutical company in India situated at Gurgaon

having a pan India presence in the ophthalmic products & other multispecialty

generic products under the flagship division of Promed.

To understand and judge better the market and prescribing patterns of

Levetiracetam we are conducting a survey through valuable support of you. A

survey report is being made by the answers and suggestions made by you.

A questionnaire is designed to collect some information regarding Levetiracetam

products being sold in the market. The information provided by you will be used

to design a product launching strategy for Levetiracetam product, we assure you

that the information will be used only to make the survey report, we shall

acknowledge your name/ your hospital/clinic name in the report and shall send a

copy of the outcome of the complied data to you.

Our representative will bring this questionnaire to you, kindly fill this

questionnaire and hand it over to our representative. A copy of the questionnaire

is attached herewith.

Thanking you and looking forward for your valuable guidance.

Promed Group

Date: ………. QUESTIONNAIRE FOR DOCTOR

1. Name of the doctor: ………………………….………

2. Specialty: i) Physician ii) Neurologist iii) Other: …………..…..

3. Name of hospital/dispensary: ……………………………………………….………

4. Generally what you write for Levetiracetam:

i) Brand Name ii) Generic Name



5. Generally which Levetiracetam brand you prescribe:

S.No. Brand name

1. …………..……… 2. ……………..…… 3. …………..………

6. In which indication you prescribe Levetiracetam:

i) Epilepsy ii) Neuropathic pain iii) Anxiety iv) Autism

v) Migraine vi) Others ………….

7. What motivates you to write above brands?

i) Company promotion ii) Price iii) Safety of drugs iv) Efficacy

v) Features and Benefits vi) Influence from Senior Doctors

8. Do you use Levetiracetam as Mono Therapy or as an Adjuvant?

………………………………………………………………………………………………………

9. What age of patient do you use Levetiracetam as Mono therapy:

i) ……………..….…….. i) …………….………………. iii) ………………………..

……….

10. What dosage of Levetiracetam do you prescribe for patients less

than

16 years of Age?

……………………………………………………………………………………………………………

…..

11. When do you prescribe Levetiracetam as Adjuvant therapy

……………………………………………………………………………………………………………

……..

12. What is Maximum dosage of Levetiracetam you recommend to your

patients per day

……………………………………………………………………………………………………………

……..

13. Is Levetiracetam your 1st Line drug in patients of Epilepsy?

……………………………………………………………………………………………………………

……..

14. Any Adverse Event reported with use of Levetiracetam

……………………………………………………………………………………………………………

……..



Date: ……….

QUESTIONNAIRE FOR WHOLESALER

1. Name of the firm:

………………………………………………………………………………..

2. Address of the firm:

…………………………………………………………………………….

3. Phone no.:

………………………………………………………………………………………………

4. Key person’s name: ………………………….

…………………………………………………..

5. Name of Levetiracetam brand(s) you are having:

S.No. Brand name Strength Price (one strip)*

1. ……………..…. ……………. MRP: Rs.…, PTR: Rs……, PTS:

Rs……

2. …………..……. ….………… MRP: Rs….. PTR: Rs……, PTS: Rs……

6. Institutional price of Levetiracetam brand (if any):

S.No. Brand name Institutional price Scheme Scheme on bulk

1. ……………..…… ……………..……. ………….. …………………..

2. …………..……… ……………..……. ………….. …………………..

7. Which are the best two Levetiracetam brands at your counter and

why: ………………………………………………………………………………………….

………………………

……………………………………………………………………………………………………………

……………….

8. What extra efforts such as extra scheme, your own contact in

institutions etc. to boost up sale of Levetiracetam brand (if any):

……………………………………………………………………………………………………………

……………….

9. Any Other information: ……………………………………………………….

…………………...

* MRP is the Maximum Retail Price, PTR is the Price To Retailer and PTS is the

Price To Stockiest.



Date: ……….

QUESTIONNAIRE FOR CHEMIST

1.Name of the firm:

……………………………………………………………………………………….

2.Address of the firm: …………………………..

……………………………………………………..

3.Phone no.:

……………………………………………………………………………………………………

4.Key person’s name:

…………………………………………………………………………………..

5.His/Her contact no.: ……………………….

………………………………………………………..

6.Top five Levetiracetam brands at your counter:

S.No. Brand name prescribed dosage form Scheme Input

i) …………………… ……….…………. ……….….. ………..

………

ii) ……………..…… ……….……….. ……….….. …………..

….

iii) …………….……. ……….……….. ……….….. ………..

………

iv) ………….………. ……….………. ……….…..

……………..…

v) …………….……. ……….……….. ……….…..

……………..…

7. Mostly Levetiracetam prescriber’s specialty:

i) Neurologist ii) Physicians iii) Surgeons iv) Others



8. Visit frequency of company’s representative for Levetiracetam brand:

i) Once in a month ii) Twice in a month iii) More then twice in a month

9. What efforts such as pushing brands, substitute by other brand etc.

you make to boost up sale of any Levetiracetam brand (if any):

……………………………………………………………………………………………………………

………………….

10. Any extra benefit received by you at time of launching Levetiracetam

brand:

S.No. Brand name Extra benefit(s)

1. …………………………… ……………………………………………………

2. …………………………… ……………………………………………………

3. …………………………… ……………………………………………………

11. Patient’s complaints such as allergy, vomiting, etc. received by you

for any Levetiracetam brand (if any): …..

……………………………………………………………………………………………………………

……………….

12. Any other information:

………………………………………………………………………………….................................

..........

4.3 TO ANALYZE AND INTERPRETATION OF DATA

Now the collected data, its time to figure out what that data means and what can

be learnt from them. The keys when analyzing data is to pull out information that

is the most pertinent to writing, information can highlight and discussed.

4.3.1 Analyzing of secondary data

The analysis of secondary data means analysis of those data, which were

already available. Secondary data analysis can be literally defined as second-

hand analysis.

It is simply the analysis of pre-existing data in a different way or to answer a

different question than originally intended. Secondary data analysis utilizes

the data that was collected by someone else.

Data and information collection for secondary data analysis will depend

entirely upon the subject that is central to the focal point of the study. The

purpose of conducting secondary data analysis is to further develop an

improved understanding of the subject matter at hand.

4.3.1.1. Pharmaceutical industry: Global scenario18,19

Pharmaceutical industry is one of the vital and distinct industries as it deals

with the lives of the people.



In calendar year 2009, the global pharmaceutical market grew 4%–6.0%, at

constant exchange rates, to US $820 billion.

A growth to 3-5 % is expected in the US at 2010.

During 2009, 25-30 new molecular entities were launched in key markets.

4.3.1.2. Pharmaceutical industry: National scenario20

The Indian pharmaceutical industry is, currently, one of the most dynamically

growing and technologically vibrant segments of the Indian manufacturing

sector.

The Indian pharmaceutical industry, which is now meeting over 95% of the

country's pharmaceutical needs, was almost non-existent before 1970.

The Indian pharmaceutical industry is expected to touch US $12 billion by

2010.

The “Bio Pharmaceutical Market” is seeing a consistent growing trend since

2004 seeing a record vaccine sale of US $386.3 million and Marketing licenses

granted for over 25 recombinant therapeutic proteins.

The “Diagnostics Market” also sees a sales market for US $138.2 Million.

It manufactures bulk drugs, belonging to several major therapeutic groups,

and has developed excellent facilities for production of all dosage forms like

tablets, capsules, liquids, ointments, orals and injectables.

The industry consisting of about 300 large and medium-scale industrial

companies including 45 Multinational Companies (MNCs) and about 10,000

small-scale enterprises in operation, which form the core of the

pharmaceutical industry in India.

Today, the domestic pharmaceutical industry is in a strong position to fulfill

the country’s major requirement of the bulk drugs and almost all the demands

for formulations.

The distributions of end-products are carried out with well-organized channel

of chemist shops throughout the country.

The production of drugs and pharmaceuticals in the country is growing at a

fast pace. The overall production of the pharmaceutical industry has grown at

a compounded annual growth rate (CAGR) of 13.2% during the calendar years

of 2009-2014.

TABLE 1: Top 10 Indian pharmaceutical industries21

RANK COMPANY

1. Cipla

2. Ranbaxy

3. Glaxo smithkline

4. Piramal Healthcare



5. Cadila

6. Sun Pharma Industries

7. Lupin lab.

8. Alkem

9. Aventis

10. Mankind

4.3.1.3. Reliability of secondary data analysis:

Reliability of the secondary data analysis has to be there, though its reliability

looks a little bit more complicated to evaluate.

A high reliability indicates that the research which has been done has to be

trustworthy. Possible variations in the output totally depend on variations of

the object measured and not due to instability of the instrument used to

measure it.

In 2004, the ORG- IMS has been created, a joint venture between ORG (the

parent entity of AC Nielsen ORG MARG) and IMS Health (the global healthcare

market intelligence company) with the intention of providing focused products

and services to the expanding healthcare and pharmaceutical sector.

ORG IMS helps clients to decide how and when to enter the market or to

launch a product, forecasts results, suggests pricing, evaluates sales

strategies, designs etc. IMS is the world’s leading provider of global business

intelligence and strategic consulting services.

Their endeavor was to enhance the capabilities of their existing products and

also launch new products that are relevant to meet their client’s existing

requirements, enabling them to take meaningful decisions.

In that sense, only the ORG-IMS (MAT) reports on their pharmaceutical study

was good guarantee of high reliability because the MAT reports were used by

almost all pharmaceutical companies.

As the data were collected from either ORG or ORG-IMS or MAT reports which

were very authentic source for analysis so we used this as basis for secondary

data analysis.

4.3.1.4. Market analysis

Marketing encompasses all of the activities that go into promoting a product

or service. A marketing analysis is the actual assessment of the target

population, competition and needs for marketing that product or service. It

also involves the research intended to predict the future of a market or

marketing research that yields information about the marketplace.

It is analysis of market data, which is used to predict movements of the

product in the market.



Conducting a market analysis is the first step in determining that there is a

market's needs for launch of a Levetiracetam product and provides key

information that is essential in developing the product/service and marketing

plan.

The company who wins the marketing game generally will capture the larger

share of the market. This market analysis also helped to enter in a new

market, launch a new product, start a new business and gain a competitive

advantage.

Secondary data analysis was done to gain a more in-depth understanding of

the growing therapeutic segment, antiepileptic segment, and levetiracetam

market status in Indian market.

Analysis of therapeutic segment22,23,24:

In market analysis, the therapeutic segment has been analyzed. The

therapeutic segment analysis is a comprehensive evaluation and analysis of

the different therapeutic areas.

This analysis helped to understand the growth trend of various therapeutic

segments in the Indian market.

The different major therapeutic segments and their market values in Rs.

billions (year wise, from year 2005 to 2009) are shown in table 2.

TABLE 2: MARKET SIZE OF THERAPEUTIC SEGMENT

S.No.THERAPEUTIC

SEGMENT

MARKET SIZE (RS BN)

2005 2006 2007 2008 2009

1. Antibiotics 38.98 46.61 51.71 55.85 63.28

2. Cardiac Therapy 26.2 25.3 28.08 30.06 29.88

3. CNS Therapy 12.0 13.3 26.4 31.6 45.97

4. NSAIDS 19.76 21.4 26.15 31.05 37.54

5. Respiratory Ailments 22.9 22.9 25.85 28.45 34.26

6. Antacids 26.62 27.1 31.08 35.84 38.96

7. Anti Diabetic 8.74 10.6 12.47 15.05 19.65

The therapeutic segment wise growth (As per ORG-IMS MAT-Mar-09) in year 2009

is shown in table 3.

TABLE 3: MARKET GROWTH IN DIFFERENT THERAPEUTIC SEGMENTS

S.NO. THERAPEUTIC AREA MARKET GROWTH($ billion)

1. Antibiotic 31.0

2. Respiratory 35.0

3. CVS 19.0

4. CNS 125.0



5. Nutritionals 15.1

6. Anti-diabetic 21.6

7. Gastro-intestinal 19.7

8. Dermatology 18.1

9. NSAIDs 32.2

10 Ophthalmic 15.5

Analysis of these figures over a period of last five years clearly indicates that

antibiotics segment was maintaining the top slot with a market size of Rs.

63.28 billion in year 2009. This segment had shown growth rate of around 9%

in current year, which was more than the total growth of Indian

pharmaceutical industry (17.6 %).

After antibiotics it can be clearly seen that the central nervous system drugs

rule at second most demanding drug product in Indian market. It has a

market size of approximately 45.97 billion in year 2009. As we can also see

that the market is keep on growing from last 5 years, i.e. there is constant

increase in CNS drugs in the market. It has a growth rate of 13.8% (source:

MAT). As per the market need this can be one of the best option for the

launch of some CNS drug (antiepileptic).

Antacids & Anti-ulcerants segment has the third biggest market having market

size of Rs. 38.96 billion in year 2009 and growing at the rate of 10.4 %.

NSAID segment was next bigger market, having market size of Rs. 37.54

billion and growing at rate of 10.3 % per annum.

The next highest growing market was respiratory ailments segment showing

growth rate same as that of NSAID medicines. However it was having market

size of Rs. 34.26 billion.

KEY FINDINGS

Key therapeutic segment like anti-infective has a high growth due to rise of

dengue and chikungunia, basically the market of anti-infective increase in

rural areas where the chances of such diseases are most but other fast

growing segments are CNS, GI, Respiratory, CVS etc due to rising incidence of

the lifestyle disease.

Anti-infective segment continues to be the largest contributor to the market;

key drugs among the anti infective are cephalosporins, penicillin’s and

quinolones. In this the cephalosporin segment alone accounts 48% of the total

anti infective market and it is the highest growing category.

As the above primary data shown that CNS holds second highest growing

market with 45.97 billion rupees and the anti depressants accounts 25% of the



total revenue of the CNS segment in year 2008-2009. Other major CNS drugs

which are highly in demand are anti-psychotics and antiepileptic. The

antipsychotics hold total revenue of 22% of the CNS segment whereas the

antiepileptic drugs have revenue of about 16.8% of the CNS segment.

Other CNS disorders are Parkinson’s disease, Locked-in syndrome, Multiple

Sclerosis, Alzheimer’s disease, Meningitis etc.

For disease like Parkinson there is no cure but medicine, surgery etc help. For

medications there are levodopa, dopamine agonist, MAO inhibitors,

amantadine, anticholinergics, clonaepam etc are used, for Meningitis is

potentially life threatening and has high mortality rate if untreated, and even

delay in treatment can also lead to death of patient. One the disorder is

confirmed then one should not delay and wide amount of antibiotics and

steroids (adjuvant treatment) like ampicillin, cephalosporin, vanomycin,

cefotaxim are available and at least one has to go for surgery.

Analysis of CNS segment:

The CNS drug market is a highly competitive market and, in some areas, the

competitive environment is being shaped by increasing levels of generic

competition. Several large pharmaceutical companies compete in the CNS

drug market.

This is one of the most competitive segments existing in the market. The CNS

segment has witnessed a high number of new product launches in the recent

years.

The CNS segment with their market values in Rs billions (year wise, from year

2005 to 2009) are shown in table 4.

TABLE 4: MARKET SIZE OF CNS SEGMENT

S.NO. AREAS 2005 2006 2007 2008 2009

1. Rupee value

(in billion)

12.0 13.35 26.47 31.60 45.97

Source: MAT 08/2005 – 08/2009

The analysis of above sales figure over a period of last five years clearly

indicates that the Indian CNS market in year 2005 was Rs. 12.0 billion, and

witnessed positive growth rate from year 2005 to year 2009. In 2009, the

market size of antibiotic was Rs.45.97 billion (as per MAT 08/2009).

As per ORG-IMS, the value growth of CNS market is 13%. The value growth is

driven due to introduction of new drugs.

It is clear that the CNS segment has huge market potential. The different

classes of CND drugs with their current market share are shown in table 5.



TABLE 5: CNS CLASSES AND THEIR MARKET GROWTH25,26,27

S.NO.

CNS MARKET GROWTH

1. Antidepressant 23.0% 2. Antipsychotic 22.6%3. Antiepileptic 16.8%

Source: Ingres, ICRA

The different classes of CNS have been analyzed. It was found that among all

the CNS classes, the antidepressant class was on top rank in market share.

The antidepressant have highest 23.0 % market share.

The increase in anti depressant is because of the fact that 1 in every 15 adult

Indian suffer from depressive illness and at least 10% of the population

requires professional and medical help according to a study by National

Institute of Mental Health and Neuro Sciences. (NIMHANS).

After the anti depressant segment, the antipsychotics and antiepileptic hold

second and third place respectively, as a large number of populations are

suffering due these disorders.

For antipsychotics there are large number of medicines available such as first

generation, second generation , third generation and among these the

examples are butyrophenones, phenothiazines, thioxanthenes, clozapine,

amisulpride etc. the third generation antipsychotics have lesser adverse

effects and the same can be used for schizophrenia patients.

A study reveals that more than 85million people worldwide have epilepsy, with

almost 90% of these people are from developing countries.

Epilepsy is a common chronic neurological disorder characterized by

unprovoked seizures. These are the signs or symptoms of abnormal, excessive

neuronal activity in the brain. It is more likely occur in young age or people

over the age of 65years; however it can occur at ant time. Even as a

consequence of brain surgery, epileptic seizures can occur in recovering

patients.

Usually a large amount of population hide it to tell in public as in many of

them have fear of loosing their job, they loose their self confidence, in many

industries, epileptic person is not allowed to work on machinery or vehicles,

also many of the patients have negative feeling, fear, anxiety etc as mixed

emotions.. One has to prove that there condition is stabilized; still many of

them have to face problems in day today life for the basic needs.

CLASSIFICATION OF ANTIEPILEPTIC DRUGS

Benzodiazepines

Bromides

Carbamates



Carboxamides

Fatty Acids

Fructose Derivative

Gaba Analog

Hydantoin

Oxazolidinediones

Propionates

Pyrimidinediones

Pyrrolidine

Succinimides

Sulfonamides

Triazine

TABLE 6: Ist and IInd GENERATION AED’S

Ist Generation Antiepileptic Drugs IInd Generation Antiepileptic Drugs

Carbamazepine (carboxamides) Felbamate (carbamate)

Phenytoin (hydantoin derivative) Gabapentin (GABA analogs)

Valproic Acid (fatty acids) Lamotrigine (triazine)

Topiramate (fructose derivative)

Tiagabine (fatty acids)

Oxcarbamazepine (carboxamide)

Levetiracetam (pyrrolidine)

Pregablin (GABA analog)

Zonisamide (sulphonamide)

Various studies reveal that second generation antiepileptic drugs are safer and

much effective than the first generation drugs.

A Look at Second Generation Most Successful Drugs

1) Lamotrigine – Triazine Derivative

Launched by SmithKline Beecham in year

Can be safely given to pregnant women

Has an indication as monotherapy in adults and children > 12 years with

partial seizure

Has good tolerability

Has an experience of 15 years worldwide

Can also be given as adjunctive in bipolar depression

Has slow titration around 5-8weeks

Patent is expired

Rashes is the common adverse event caused due to intake of lamotrigine, and

it gets severe in many cases



Also cause severe adverse reaction with Carbamazepine

Many generics are now available in market due to expiry of patent

Generics available in market are:

Lamotrigine (tablets, chewable) – Aurobindo Pharma

Lamotrigine (tablets, chewable) – Dr. Reddys Lab

Lamotrigine (tablets, chewable) – Glaxo SmithKline

Lamotrigine (tablets, chewable) – Glenmark

Lamotrigine (tablets, chewable) – TAPI (subsidiary of Teva)

Lamotrigine (tablets, chewable) – Watson Labs

Lamotrigine (tablets, chewable) – Zydus

Lamictal XR (tablets, extended release) – SmithKline Beecham

Lamez OD (tablets, extended release) – Intas Pharma

Lamictal ODT (tablets, orally disintegrating) - SmithKline Beecham

Lamotrigine (tablets) – Apotex Inc

Lamotrigine (tablets) – Aurobindo Pharma

Lamotrigine (tablets) – Cadista Pharms

Lamotrigine (tablets) – Dr Reddys Lab

Lamotrigine (tablets) – Glaxo SmithKline

Lamotrigine (tablets) – Lupin Ltd.

Lamotrigine (tablets) – Matrix Labs.

Lamotrigine (tablets) – Taro Pharms IND

Lamotrigine (tablets) – TAPI (subsidiary of Teva)

Lamotrigine (tablets) – Torrent Pharma

Lamotrigine (tablets) – Zydus Pharma

Lamez (tablets) – Intas Pharma

Vimpat (tablets) – UCB

2) Pregabalin – GABA Analogs

Launched by Pfizer in 2006

Has rapid onset of action

Has low price than other antiepileptic drugs

Mainly prescribed for neuropathic pain, the use of pregabaline as an

antiepileptic drug is lower down because as its safety profile is unproved, it

suppress the seizure for a limited period of time, freedom from epilepsy is not

proved during trials and in post marketing trials

Major side effects are: weight gain, falls and injuries in older patients,

peripheral edema, dizziness, somnolence at high dose, potential to invoke

myoclonic seizure.

Safety profile – unproved



Seizure freedom – no

Not a broad spectrum antiepileptic drug

Has pharmacodynamic interaction with oxycodone, lorazepam, alcohol

Have more sales growth outside epilepsy

generics available in market are:

Pregabid Forte (tablets) – Intas Pharma

Pregabid 50 (tablets) – Intas Pharma

Lyrica (solution) – Pfizer

Lyrica (capsule) - Pfizer

Pregadoc (capsule) – Lupin

Pregabaline (capsule) – Sun Pharmaceuticals Industries Ltd.

3) Topiramate – Fructose Derivative

very effective AED

have broad spectrum indications:- monotherapy in adults and children’s > 6

years with newly diagnosed epilepsy, adjunctive in children’s with partial

seizure or primary generalized tonic clonic seizure

have few drug interaction

have 9 years of market experience and almost 1 million patients treated

also have potential prevention from migraine

have poor tolerability

slow titration up to 8 weeks

side effects like:- mental slowing, speech disturbances, psychiatric side effect,

kidney stone formation, lead to glaucoma, severe eye problems, acute myopia,

eye pain, paraesthesia, metabolic acidosis, interaction with oral contraceptives

and other AED

It was sold on the basis of efficacy as have high level of seizure control

It fails to gain the rise of market due to slow titration, poor tolerability and also

the major reason is the introduction of more effective AED’s with lesser side

effects and now it is used as a drug used for treatment of migraine and also

gaining the market size in the treatment of migraine.

Topiramate is available in capsules and tablets dosage form of different

strength.

Capsule in 15 MG and 25MG, whereas the tablet is available in 15MG, 25MG,

50MG, 100MG and 200MG.

generics available are as follows:

Topamax (Tablets) – Ortho Mc Neil Pharmaceutical Inc. (subsidiary of

Jhonson & Jhonson)

Topiramate (Capsule) – Watson Labs.

Topiramate (Tablets) – Aurobindo Pharma.



Topiramate (Tablets) – Cipla

Topiramate (Tablets) – Ranbaxy

Topiramate (Tablets) - Sun Pharmaceutical Industries Ltd.

Topiramate (Tablets) – Torrent Pharms

Topiramate (Tablets) – Glenmark

Topiramate (Tablets) – Wockhardt

Topiramate (Tablets) – Watson Labs

Topiramate (Tablets) – TAPI (subsidiary of Teva)

Topiramate (Tablets) – Zydus Pharma

Topiramate (Tablets) – Unichem

Topiramate (Tablets) – Accord Healthcare (subsidiary of Intas

Pharma)

Topaz (tablets) – Intas Pharma

4) Oxcarbazepine - Carboxamide Derivative

consider as effective in partial seizures

Indication for mono or adjunctive therapy in adults and children’s of 6 years of

age and above.

Chemically similar to Carbamazepine

Have better tolerability than topiramate

It induces certain hepatic enzymes, and also leads to hyponatremia (abnormal

decrease in blood sodium concentration)

More expensive

Generics available in Indian market are:

Trileptal (tablets, suspension) – Novartis

Oxcarbamazepine (tablet) – Ranbaxy

Oxcarbamazepine (tablet) – Apotex

Oxcarbamazepine (tablet) – Cadista Pharms

Oxcarbamazepine (tablet) – Glenmark

Oxcarbamazepine (tablet) – Sun Pharmaceutical Industries

Oxcarbamazepine (tablet) - Taro

Oxcarbamazepine (tablet) – Teva

5) Gabapentin – GABA Analogs

till 2007 the sale is increased and alone the innovator, Pfizer had more than 12

million patients at the time of launch i.e. 1994

market sale is increased due to drug’s ability of seizure control and high

tolerability

low price generics are available



it is also indicated for the treatment of neuropathic pain

have poor absorption

it may worsen the myoclonic and absence seizure

now used more outside epilepsy

good efficacy is obtained at high dose

available dosage forms are tablets, capsule, solution

available strength in capsule dosage form are 100MG, 300MG and 400 MG, in

tablets are 100MG, 300MG, 400MG, 600MG and 800MG, and the solution is

available in 250MG/5ML

several generics available are:

Neurontin (capsule) – Pfizer

Gabapentin (capsule) – Ranbaxy

Gabapentin (capsule) – Sun Pharmaceutical Industries

Gabapentin (capsule) – Watson Labs

Gabapentin (tablet) – Glenmark

Neurontin (tablet) – Pfizer

Neurontin (solution) – Pfizer

Gabapentin (tablets) – Sun Pharmaceutical Industries

6) Tiagabine – Fatty Acids

has good tolerability

no interaction with oral contraceptives

not as effective as that of other AED

have very narrow indication

require daily 2-3 times dosing

the ability of the drug is affected by the other AED’S

have slow titration

it is taken after meals only

high dose is only permitted in less countries

7) Levetiracetam – Pyrrolidine

broad spectrum indications

good tolerability

no clinical significant drug – drug interaction

indications – monotherapy in treatment of partial onset seizures with or without

secondary generalization in patients from 16years of age with newly diagnosed

epilepsy



- as an adjunctive therapy in the treatment of partial onset seizures

with or without secondary generalization in adults and children’s from 4years

of age with epilepsy

- as an adjunctive therapy in treatment of myoclonic seizures in adult

and adolescents from 12 years of age with juvenile myoclonic epilepsy

- as an adjunctive therapy in the treatment of primary generalized

tonic-clonic seizure in adults and adolescents from 12 years of age with

idiopathic generalized epilepsy

oral solutions and intravenous preparation are also available for the treatment

of epilepsy in infants

also used in treatment of neuropathic pain

has potential benefits for other psychiatric and neurologic conditions such as

Tourette syndrome, autism, and anxiety disorder

have side effects like – hair loss, pins and needle sensation in extremities,

anxiety, irritability to depression, headache, nausea

the patient is not allowed to drive or to do any type of machinery work in initial

stages of the treatment, however the doctor consultation is required

well tolerated by adults as well as by children’s

give complete seizure freedom, has rapid action

the adverse drug reactions are not dose related and also there is no

requirement of the dose adjustments of concomitant anti epileptic drugs

available in different dosage forms i.e. solid, liquid and iv

the available strength in tablets are 250mg, 500mg, 750mg and 1000mg and

also they are available in different colors as per their strength

the oral solution is available in strength of 100mg/ml as presented as 300 ml

bottle with calibrated dispenser

the generics available in Indian market are

Levesam (tablet) – Piramal Healthcare

Levera (solution) – Intas Pharma

Levipil (tablet) – Sun Pharmaceutical Industries

Levroxa (tablet) – Ranbaxy

Levtam (tablet) – Unichem

Torleva (tablet) – Torrent Pharma

Epictal (tablet) – IPCA

Epilive (tablet) – Lupin Labs

Keppra(tablet, solution) – UCB Pharma Inc.

In second generation the newly launched Levetiracetam and Gabapentin are

considered to be drugs with lesser side effects. The Levetiracetam is chosen for

the launch because it has the most least side effects till now, even lesser than



Gabapentin, antiepileptic drugs have one major adverse effect and that is the

suicidal behavior, in case with Levetiracetam, it is having a rate of 1 in 500

patients and US FDA also have considered it as the best and most safest

medication for the treatment of epilepsy.

The Levetiracetam drug belongs to Pyrrolidine group and the Levetiracetam drug

is first launched in 1999 and considered as most effective and safe antiepileptic

drug.

CLASSICAL AED’s or FIRST GENERATION AED’s

1) Phenytoin

First line monotherapy for partial and tonic clonic seizures

High degree of physician familiarity, experience and sales

Highly effective and have broad range of indications

Fast onset of action

Multiple dosage form is available like capsules, tablets, i.v, suspension,

infantabs and kapseals)

Side effect profile:- rashes, impair cognitive function, gum hyperplasia, skin

rash, leucopenia, drowsiness)

Long half life (22 hours)

Serum monitoring is required

Teratogenic in animals and also malformation like heart malformation is seen

in humans.

The generics available in Indian market are:

2) Carbamazepine

Indicated as first line monotherapy for partial and tonic clonic seizure and it

also claims that it controls seizures in easy way with twice a day dose therapy.

Drug is having an experience of 25years worldwide

Has low risk of cognitive impairments

Available in multiple dosage form like immediate release tablets, chewable

tablets, oral suspension, extended release tablets.

The drug is having low price

Serious adverse drug reaction includes: aplastic anemia, agarnulocytosis and

others are somnolence, fatigue, drowsiness, ataxia, double vision, skin rash.

Has slow titration

3) Valproic Acid

Used mainly outside epilepsy treatment

Also indicated for the treatment of the migraine, maniac episodes associated

with the bipolar disorders



Effective in generalized epilepsy

Available in multiple dosage forms such as capsules, tablets, i.v. , syrups,

delayed release tablets, extended release tablets, sprinkle formulation.

Quite a cheap AED

Have serious adverse drug reactions are observed and warning are given

specially for hepatic failure, pancreatitis, others side effects are hair loss,

tremor, nausea, weight gain, potential liver problems etc.

Adverse drug reaction also associated with the verbal abilities, manifested

development delay, cognitive impairment

For dosing, the patient needs to take the dose 2-4 times a day

Analysis of Levetiracetam28:

Levetiracetam is the highest growing category within the anti-convulsant

segment worldwide and hence in India too with a compound annual growth

rate (CAGR) of 21.4 per cent over last 5 years.

Levetiracetam is used to treat partial onset seizure with patients of age 4

years or older, used as an adjunctive therapy in treating myoclonic seizure in

patients of age 12 years or older with juvenile myoclonic epilepsy, and in

primary generalized tonic clonic seizure with patients of age 6years or older

with idiopathic generalized epilepsy.

In India, the leading players of Levetiracetam are UCB’s “Keppra”, Ranbaxy’s

“Levroxa”, Sun Pharma’s “Levipil”, Lupin Labs “Epilive” and Torrent Pharma’s

“Torleva”.

Most of antiepileptic drugs have to face competition with their generic brands.

Among all antiepileptic drugs, the Levetiracetam drug has less generic

competition in Indian market as the patent of the molecule is expired recently.

The market size of Levetiracetam has been analyzed from year 2007 to year

2009. It was found that there was continuous increase in market size of

Levetiracetam year after year.

Now by this time, it was very clear that for a new product launching, the

Levetiracetam is right choice.

Analysis at doctor level:

The survey has been made at the doctor level. Total 25 doctors have been

surveyed with the different specialty. Out of those 17 doctors have responded

well. The Levetiracetam was written mostly by the neurologists and surgeons.

They were surveyed for their prescribing habits i.e. whether they used to

prescribe the branded product or generic product for Levetiracetam drug. A



total of 80 % of the doctors preferred to write branded product for

Levetiracetam antiepileptic drug.

They were also surveyed for the basis of brand name, dosage form, strength

and indications, which they used for Levetiracetam product. 90 % doctors

write tablet dosage form in strength of 500 mg, 750 mg and 1000mg. The

indications used by these specialties are in the treatment of partial onset

seizure, myoclonic seizure, tonic clonic etc in children’s as well as in adults

and also the oral solution is prescribed for the treatment of epilepsy in infants

and neonates.

This survey also included the criteria for prescribing the Levetiracetam brand

and 70 % doctors gave weight age to price of the product and for 50 % doctor

are in favor for the company policies was important for prescribing the

Levetiracetam brand.

The best company’s promotional strategy for Levetiracetam product had

been surveyed from them and it was found that the UCB, Ranbaxy, Sun

Pharmaceutical Industries, Torrent and Lupin Labs have good strategy for their

Levetiracetam product.

Key finding:

It was found that total 80 % doctors used to write branded product while

writing the Levetiracetam brand.

The tablet dosage form in strength of 500 mg, 750mg and 1000 mg were

preferred by 90 % of doctors for Levetiracetam product.

The physicians used to write this drug mainly for different types of epilepsy,

neuropathic pain while the surgeons prescribe them in conditions like the

epilepsy arise due to consequence of the brain surgery.

Total of 70 % doctors gave waightage to the price and 50% doctors give

thumbs up for the company’s policies for prescribing the Levetiracetam brand.

TO MAKE STRATEGY FOR LEVETIRACETAM PRODUCT

Developing launch strategy is the final stage of new product development. By

now the product is market ready and consumer tested. The business is keen to

take the product to the market.

The success of a new product depends not only on the idea behind the product,

but also on the marketing of the new product before, during and after the

product launch. New product launching is part of the new product development

method.

This stage, often known as commercialization. This is when the business needs

to commit to marketing investment and will rely on key distribution outlets for

their support and this is the point when policy maker relinquish control to the



consumer, in market, the consumer will decide between success and failure.

Having a clear strategy is crucial to both a successful launch and managing the

product in the early stages of its life-cycle.

The strategy for a new product can be classified in two groups.

1. Strategic planning.

2. Tactical planning.

Strategic planning

A strategic planning gives a long-term vision about the new product. During

the first activity, research was conducted to create a strategic plan for

launching the new product. In this the strategy maker has to consider the

following-

Define market strategy

Once the company has obtained an adequate understanding of the customer

base and its own competitive position in the industry, marketing managers are

able to make key strategic decisions and develop a marketing strategy

designed to maximize the revenues and profits of the firm. The selected

strategy may aim for any of a variety of specific objectives, including

optimizing short-term unit margins, revenue growth, market share, long-term

profitability, or other goals.

Defining the market strategy gives insight in the actions that are necessary to

achieve marketing objectives. It should be clear that who will be the customers

of product, and how the company’s offering meets customer needs better than

all options, it needs to develop an effective way of communicating this to its

target customers. The company has to get familiar with the market and must

decide how and where to place the product in the market. Other actions are

the way to approach potential customers, and the way to attract the targeting

customer group (for example, low prices or high quality).

Market strategy serves as a way to position the company and the product

successfully and uniquely in the market.

It can consist of market analysis, consumer analysis, company analysis,

marketing strategy and sales approach. In short the market strategy should be

able to answer against top companies, small companies and against other

leading drugs/ dosage forms.

Strategy: whom to HIT



The company has to decide to whom to hit. As the company is looking this drug

as a blockbuster drug and further this drug has highest growing rate among all

AED’s. So the company wants’ to give extra attention to market this drug.

For this company has decided to hit those companies strategies which have

their Levetiracetam product in top five rank i.e. the brands against which the

company has decided to hit their strategy are Keppra (UCB Inc), Levroxa

(Ranbaxy), Levipil (Sun Pharmaceutical Industries), Torleva (Torrent) and

Epilive (Lupin Labs).

Strategy: Killing strategy

The strategy is to be made to whom to kill (killing strategy) in the market. As

the company has set their objective to be among top five brands in next five

years for their Levetiracetam brand so the strategy is to be made to kill the

small competitor’s brands which are having less market size.

The company decided to go with some innovative activities which the

competitors are not doing. For this a campaign is to be made for potential

customers.

(A) Campaign for the doctors:

The company has to decide the way to approach potential customers. It was

found from primary and secondary doctor data analysis that around 80 %

companies were not having any special campaign for the doctors. Most of them

are targeting the potential customers either by giving costly inputs or by

providing sponsorship. The major drawback in this type of promotion is the non

continuousness in giving the new prescriptions.

The company has decided to target these potential customers by making a

special theme for them. For this a special campaign was made. The basic aim

behind this campaign is to build the long term business relation with the

customers (doctors).

And also to spread awareness regarding the severity of the disorder and how it

influences the day today life of a patient who is aware of the disorder but have

fear regarding the treatment and also have fear of loosing job etc. another

major aim is to let the doctors know about the efficacy, safety and quality of

the new launched product and also defined how it is different from the existing

products.

In this campaign, slightly costly inputs will be given to the selected customers

who will relate to the theme so as to remind him about the product.

Moreover, the managers will also be involved and they will do some unique

activity under this campaign. The aim behind this is to provide customer

satisfaction (ego boost up) and make the long term business relations with the

potential customers.



Define company strategy:

Defining the company strategy, also known as business strategy, specifies the

objectives of the company in relation to the new product. Policies, plans and

resources that are needed to achieve these objectives are defined in this

activity.

Company strategy is a plan for fulfilling long-term company objectives.

It consists of situational analysis, vision and mission statements, strategic and

tactical objectives, SWOT analysis and implementation of plan objectives.

Launching in New Delhi and NCR:

The place or area is very important for any new launching product. It can be

national, regional, district or micro interior wide launch.

The company has decided to launch the Levetiracetam product in New Delhi

and NCR

Projections:

The company strategy mainly include the projection that where the company

wants to see their new product after five years. So the company has to give the

projections for their new product.

Launching activity:

There are many players in the Levetiracetam market and if the company will

launch a one more Levetiracetam brand to the market, then it will be among

one of the player and there will not be special recognition at the doctor level.

To give a threat to the competitor’s Levetiracetam brands and making the fast

recognition at the doctor level, a special way of launching of new product is

essential.

The company has decided to launch its Levetiracetam product with some

special launching activity.

Define product strategy:

The element of a firm's decision-making concerned with developing the most

appropriate products for its target market is called as product strategy.

A product strategy supports and complements the overall marketing strategy.

Defining the product strategy gives insight in strategic product characteristics

as the innovativeness, product newness and the product life cycle (PLC) time.

Purpose of the product strategy is help to creating the right expectations of a

product.

It consists of form of the product, color of the product, shape of the product,

product comparison, PLC, new product development cycle time and product

development planning for the future.


http://en.wikipedia.org/wiki/Business_strategy

http://en.wikipedia.org/wiki/New_product_development

http://en.wikipedia.org/wiki/Product_life_cycle

http://en.wikipedia.org/wiki/SWOT_analysis


5.4.1.5.1. Most appropriate products (strength and dosage form):

In the Levetiracetam market, many brands are available in different strength

and different dosage forms and all are having their own market size.

As there is huge Levetiracetam market and company is looking this

Levetiracetam product as a blockbuster product, so company wants to grab the

maximum market share from competitors as fast as possible.

So the company has decided to launch its Levetiracetam product in most

appropriate form i.e. in most appropriate strength and dosage form.

For this, those strengths and dosage forms will be selected which is maximum

market size.

Tactical planning

A tactical planning gives a short-term vision about the new product. After

creating a strategically planning, an approach for launching the new product

has to be defined. The outcome of this activity is a tactical plan.

The tactical planning contains the following-

(i) Create a theme

It is not necessary that every new launching brand have a theme; however it is

better that a new brand is launched with a theme.

A theme was generated for launching a new brand of Levetiracetam.

Since the product is an antiepileptic drug so a theme related to this action was

to be made.

The theme was generated on the basis of above thought/statement and it is as

follows:-

“A WAY OF LIFE”

Choose brand name:

A brand for the product has to be chosen. The company has to decide whether

to create a new brand, make an extension of a brand, or that the product falls

under an existing brand.

Purpose is to place the new product in the line of other products in the

company.

It is decided by the company to launch a new brand which contains the

Levetiracetam.

For a new brand, there are several methods for choosing a new brand name

like it can be among words from generic name of drug or similar to remaining

brands of company or similar to innovator brand of the drug or from slogan of


http://en.wikipedia.org/wiki/Brand


the launching product or related to theme of the product and from randomized

method.

Any single or combination of any of these method can be used, but care should

be taken that the brand name should be very catchy, easy to write and

understand and easy to remember.

The brand name of the launching product has been chosen by using

combination of two methods i.e. related to theme of the product and among

words from generic name of drug.

The brand name which was chosen is PROLEVA.

The PRO word is the initial of the company, and LEVA is related to compound

Levetiracetam. So this antiepileptic product is related to the Promed group.

The PROLEVA name was chosen as it was very catchy, easy to write, remember

and related to theme as well.

Further the name PROLEVA does not matched with the name of already

available Levetiracetam brands.

Selection of strength and dosage form:

The strength and dosage form of PROLEVA has to be decided. It was found

from primary and secondary survey analysis that the strength for

Levetiracetam was available in 250 mg, 500mg, 750mg and 1000 mg. About

95 % of companies have their Levetiracetam formulation in 250 mg, 500mg

and 750mg strength as these were found enough to treat the epilepsy with

monotherapy or with adjunctive therapy with other AED’s.

The Levetiracetam can be given by orally. The most convenient route is the

oral route so company decided to launch PROLEVA in the oral dosage form.

In the oral dosage form, the Levetiracetam is available in the tablet, and in

solution forms in the Indian market i.e. in oral dosage form again it can be

given as solid dosage form or as liquid dosage form.

It was found from secondary data analysis that total current Levetiracetam

market was 1.91 billion (MAT 08/2009 report) and out of this total 73.29 %

Levetiracetam has been sold in solid dosage form i.e. Levetiracetam solid has

market of 1.40 billion while Levetiracetam liquid has market of Rs. 0.51 billion

(MAT 08/2009 report).

Further, it was found that the Levetiracetam market is growing by 18 % (in Rs

value) while the Levetiracetam solid dosage form market is growing by 20 %

and Levetiracetam liquid dosage form market is growing by just 5 %. It means

that its solid dosage form’s market is growing much faster than its total

Levetiracetam market.

In unit wise market, the total Levetiracetam is growing by 14 % while

Levetiracetam solid is growing by 16 % (MAT 08/2009 report).



It was very clear that Levetiracetam solid market is fastest growing market so

company decided to launch PROLEVA in solid dosage form.

So company has decided to launch PROLEVA in tablet dosage form with

1000mg strength. This strength will be promoted to neurologists, and

surgeon’s specialty. The selected strength with their specialty is shown in table

9.

TABLE 9: STRENGTH SELECTED FOR SPECIALTY

S.NO. SPECIALTY TARGET STRENGTHS

1. Neurologists 1000 mg2. Surgeons 1000mg

Composition:

The each tablet of PROLEVA 1000 mg contains the Levetiracetam which is

equivalent to Levetiracetam 1000 mg. as well as Vitamin B-complex.

The Detailed Composition is shown in table no.10

TABLE 10: COMPOSITION OF LEVETIRACETAM

Packing:

The strategy has to plan for packing of product at every level. It depends upon

the type of drug used and total days of therapy.

Packaging is the art of and the operations involved in the preparation of

articles or product for carriage, storage and delivery.

In most retailing today, products come in packages; indeed, the package has

become an integral part of the product. It protects the product, promotes and

advertises the product (labeling design, coupons, and reusable containers) and

may display the product or make it more visible. It may be a convenient means

for dispensing contents (liquid soaps, oil, glue, toothpaste), and may carry

important information about the contents of the product (required by law) and

directions for its use.


Levetiracetam 1000 mg.

Crossmellose Sodium 43.0 mg.

Macrogol 6000 10.0 mg.

Anhydrous colloidal silica 20.75 mg.

Magnesium stearate 1.25 mg.

Opadry with polyvinyl alcohol 32.25 mg.

Talc 20.0 mg.


The packaging should be planned for the following-

Blister/strip packing:

It is to be finalized in which package, the PROLEVA will be packed. For the

packing of PROLEVA the Aluminum blister packaging is decided, as it will be

attractive than other packing and it will not effect on selling of PROLEVA

product.

A blister package is a form of unit dose packaging that is commonly used for

the packaging of tablets and capsules. A blister package is formed by feeding

two webs of a heat-sealed flexible film through either a heated crimping roller

or a heated reciprocating plate, the product is dropped in between the

aluminum sheets and sealing is done.

Sales pack:

It is to be decided that a strip of PROLEVA contain how many tablets. The company

has decided that a strip of PROLEVA will contain seven tablets. This will be more

convenient for patients to purchase a whole strip in spite of more or less tablets.

The tablets in sales packing are shown in table 11.

TABLE 11: SALES PACKING OF PROLEVA

S.No. Sales packing Tablets/strip

1. PROLEVA1000 mg

7 tablets

Box packing:

Box packing means that a box of PROLEVA contains how many strips. Again it

varies from company to company. Although the variations in box packing doesn’t

affects the sale of the product. However, it should be convenient for distributor,

wholesaler, chemist and patients. So the company has decided that a box of

PROLEVA shall contain seven strips of product.

TABLE 12: BOX PACKING OF PROLEVA

S.NO. BOX PACKING STRIPS/BOX

1. PROLEVA

1000 mg

7 strips

Carton pack:

Carton packing is the packing of PROLEVA boxes in a carton that is made of

cardboard; opens by flaps on top. It is the name of certain types of containers



typically made from paperboard, which is also sometimes known as

"cardboard".

The carton pack shall also be used for storage and transport of PROLEVA i.e. as

the shipper pack.

The carton packing has been decided as per the sales objectives of PROLEVA. It

was kept in mind while deciding the carton packing of PROLEVA that when the

wholesalers place an order requisition for PROLEVA, they will receive the

product either in sufficient quantity or some more quantity so that the problem

of product shortage will not be there hence it doesn’t affect the sale of

PROLEVA.

As 1000mg strength of PROLEVA will be promoted to physician, neurologists

and the surgeons, hence it is expected that the sale of 1000 mg of PROLEVA

will be more. So the carton packing for both the strength will be different.

It was decided that a carton of PROLEVA 1000 mg will contain the twenty boxes

of PROLEVA 1000 mg. The carton packing for PROLEVA is shown in table 14.

TABLE 13: CARTON PACKING OF PROLEVA

S.NO. CARTON PACKING BOXES/CARTON

1. PROLEVA 1000 mg 20 boxes

Sample Pack

The sample pack means that the numbers of PROLEVA tablets packed in a strip

which will be given to doctors as a “physician sample”. These sample packs are

not for sale and “Physician sample, not for sale” is also written on every strip of

the sample pack

The main purpose of the sample pack is to remind the PROLEVA brand to the

doctors and also to help the poor patients by providing free samples to them.

Generally in one sample pack, the number of tablets is less than its main strip

pack. As the main PROLEVA strip pack contains ten tablets of PROLEVA, so its

sample pack will contain less tablets of PROLEVA in its one sample pack.

The company has decided that the one sample pack of PROLEVA will contain

only two tablets of PROLEVA, as this tablet is expensive too.

TABLE 14: SAMPLE PACKING OF PROLEVA

S.NO. SAMPLE PACKING CAPSULES/STRIP

1. PROLEVA

1000 mg

02 TABLETS

Promotion expenditures



Promotional budget is the sum allocated in a particular accounting period for

expenditure on promotion.

A detailed budget for the promotion activities has to be defined. With this

budget, the promotion of the new product can be designed and started.

Generally the promotional expenditures for a new launching product are higher

than the promotional expenditure of the existing brands.

“Rs. 3.5 lack” (hypothetical) was decided as the promotional expenditure for

PROLEVA.

This promotional expenditure includes Promotional Inputs, Samples, Launching

activity

Sales force intensity

The size of the sales force has to be defined. The size depends on the

expectations of the product; will it demand much effort to sell and will it sell

much?

This plan contains information about the promotion costs and activities and is

part of the tactical plan.

For the PROLEVA promotion, the sale force is decided as same as sale force for

other products of Promed Group.

The sale force for PROLEVA is 25 for New Delhi.

Distribution plan

The distribution channel has to be chosen. It could be an existing distribution

channel, that the company already uses, or it could also be a new kind of

distribution channel.

The combination of “define distribution expenditures” and “define distribution

intensity” forms a distribution plan.

The purpose of defining the distribution expenditures is that it gives a clear

view on the costs for distributing the new product. This information can be

used in calculating the price level of the product.

For PROLEVA, the distribution channel is decided as the same as existing one;

as it was time tested with the existing products of Promed Group.

Pricing policy

(1) Discount/ scheme policy

The company has to make a price policy. Discounts can be given to wholesalers

or chemists, who buy large batches of a product. It is also possible to create

different price levels for different customer groups and geographical locations.

Purpose to create attractive opportunities for consumers, so that they tend to

buy the product faster.


http://en.wikipedia.org/wiki/Quantity_discounts


It was found from analysis of primary and secondary data that 80 % of

companies are not giving any discount or scheme to wholesalers and chemists.

As Levetiracetam is the new launching brand and not new in the market so it is

decided that on PROLEVA 15% - 20 % scheme shall be given to the chemists on

purchasing at least one box (containing seven strips) of PROLEVA and 10% - 12

% scheme to the wholesalers on purchasing at least ten box of PROLEVA.

It is also decided that no scheme will be given to the chemists and wholesalers,

if they do not purchase the specified quantity of PROLEVA.

Launching activity

Any launching of a new product with a special theme or activity, it will give more

impact on the customers. For launching the PROLEVA, the special activity has to

be planed and that is divided into two parts i.e. pre launching activity and

launching activity.

(i) Pre launching activity

Pre launching activity is a part of launching of a new product to the market.

This activity was carried out by company itself i.e. from company’s head-

quarter. The main aim behind this activity is to generate the queries among

doctors for a new product before actual launching of it to the market.

For this, the mailer (treasures) was prepared. Several things were kept in mind

while preparing this mailer like theme of the product, brand name of new

launching product, indications and unique points etc.

The mailer was sent one month before the launching month to the doctors from

the company’s head-quarter. Before sending this mailer to doctors, the mailing

list of 50 doctors (only campaign doctors) has been collected from medical

representatives from each territory.

In this mailer the indications were written and a sentence. This sentence was

“Why to control your patients seizure attacks for a while, when we are bringing

you the freedom “. Company mane should also be there in mailer. This will give

a click into doctor’s mind that company is coming with an antiepileptic drug

product which will be used in these indications.


Lachoo Memorial College of Science and Technology, Pharmacy Wing, Jodhpur

Lachoo Memorial College Of Science and Technology, Pharmacy Wing, Jodhpur

Umang Project

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