Top 25 Drugs in USA 2012Data provided by IMS HealthBy prescription volume in the millions (i.e

10=10,000,000)For the full list please visit:

http://www.pharmacytimes.com/publications/issue/2013/July2013/Top-200-Drugs-of-2012

Rank

Drug Manu. Other Names

Used for RX Volume (in the millions)

1 Hydrocodone/APAP

Actavis Vicodin, Lorcet, Norco, Maxidone

Pain managment 56

2 Levothyroxine Mylan Levoxyl, Synthroid, Unithroid

Hypothyroidism 47

3 Hydrocodone/APAP

Mallinkrodt

Vicodin, Lorcet, Norco, Maxidone

Pain managment 44

4 Lisinopril Lupin Prinvil, Zestril

CHF, HTN 42

5 Hydrocodone/APAP

Qualitest See 1,3 See 1,3 27

Rank Drug Manu Other Names

Used for Rx Volume (millions)

6 Simvastatin Lupin Zocor Secondary Prevention of MI by reducing cholesterol

27

7 Azithromycin

Teva Zithromax, Z-Pak, ZMax, TriPak

Upper Respiratory Infections

26

8 Proair HFA Teva Albuterol, Accuneb, Vospire ER, Proventil

COPD, Asthma

25

9 Crestor AstraZeneca Rosuvastatin Secondary Prevention of MI by reducing cholesterol

25

10 Levothyroxine

Lannett Synthroid, levoxyl, unithroid

Hypothyroidism

25

Rank Drug Manu Other Names

Used for Rx Volume (in millions)

11 Synthroid Abbvie Synthroid, levoxyl, unithroid

Hypothyroidism

23

12 Nexium AstraZeneca Esomeprazole

GERD, acid reflux, and Zollinger Ellison

22

13 Atorvastatin Ranbaxy Lipitor Secondary Prevention of MI by reducing cholesterol

22

14 Ibuprofen Amneal Motrin, Advil, Addaprin, Ultraprin

Pain, Inflammation

21

Rank Drug Manu. Also KnownAs

Used for RX Volume (in the millions)

15 Trazodone Teva Oleptro, Desyrel

Depression, Sleep aid,

21

16 Metoprolol Mylan Lopressor, Toprol

MI (IV form); CHF, HTN

20

17 Azithromycin Greenstone Zithromax URI 20

18 Warfarin Taro Coumadin, Jantoven

Anticoagulant for TE disorders

19

19 Cymbalta Eli Lilly Duloxetine Antidpressant, Neuropathic pain (unlabeled)

18

20 Fluticasone Proprionate

Roxane Flonase (nasal), Flovent, Veramyst (Nasal)

COPD, seasonal allergic rhinitis

18

Rank

Drug Manu Other Names

Used for Rx Volume(in the millions)

21 Singulair Merck Montelukast Asthma N/G

22 Hydrochlorothazide Qualitest HCTZ, Hydrodiuril, Microzide

HTN N/G

23 Ventolin HFA GlaxoSmith Kline

Albuterol, Accuneb, Proventil

asthma N/G

24 Advair Diskus GlaxoSmith Kline

Fluticasone/Salmeterol

COPD, asthma

N/G

25 Amoxicillin Sandoz Amoxil, Moxatag

URI, Otitis Media

N/G

Rank

Drug Used for Dollar Sales (billions)

1 Nexium ®(Esomeprzole) GERD 5.9

2 Abilify ® (Aripiprazole) Schizoprenia, Bipolar disorder

5.8

3 Crestor ® (Rosuvastatin) Hypercholesterolemia

5

4 Advair Diskus ®(fluticasone/Salmeterol)

COPD 4.8

5 Cymbalta (Duloxetine) Depression, Neuropathic pain (unlabeled)

4.7

Top 25 Drugs in 2012 in the US by Dollar Sales

Rank

Drug Used for Dollar Sales (billions)

6 Humira ® (adalimumab) RA, UC, Crohn’s Disease, AS

4.6

7 Enbrel ®(etanercept) RA, UC, Crohn’s Disease, AS

4.3

8 Remicade ® (Infliximab) RA, UC, Crohn’s Disease, AS

3.8

9 Copaxone ® (glatiramer Acetate)

Relapsing Remitting MS

3.5

10 Neulasta ® (Pegfilgrastim) Prevention of infection in chemo receiving patients

3.4

Rank

Drug Used for Dollar Sales (billions)

11 Singulair® (Montelukast) Asthma 3.3

12 Rituxan ®(Rituximab) CD20 AB

Chronic Lymphocytic leukemia, and in severe RA

3.1

13 Plavix ® (clopidgrel) Stroke/MI prevention

2.9

14 Atripla ®emtricitabine/tenofovir/efavirenz

HIV infection

2.8

15 Spiriva® (Tiotropium) COPD, asthma

2.8

Rank

Drug Used for Dollar Sales (billions)

16 Oxycontin® (Oxycodone) Pain 2.8

17 Januvia ® (sitagliptin) Type 2 DM 2.6

18 Avastin ® (bevacizumab) Colorectal Cancer

2.6

19 Lantus ® (Insulin Glargine)

Type 1 and Type 2 DM, basal insulin

2.3

20 Truvada® (emtricitabine/tenofovir)

HIV infection 2.3

Rank

Drug Used for Dollar Sales (billions)

21 Lantus Solostar ®(insulin glargine) (Pen filled dose form)

Type 1 and Type 2 DM

NG

22 Epogen ® (erythropoetin) Anemia due to chemo , renal and other blood disorders

NG

23 Diovan ® (Valsartan) CHF, MI and HTN

NG

24 Lyrica® (Pregabalin) Neuropathic Pain relief

NG

25 Lipitor® (Atorvastatin) Cholesterol reduction

NG

FDA Drug Approval ProcessIn general, the process involves:

Chemical drug developmentAnimal testingHuman testingFiling application to FDA

New Drug Application (NDA) Biologics License Application (BLA)

Approval by FDAContinuous Market Surveillance

Chemical development involves knowledge of the drug’s chemical properties and proposed pharmacology

Animal testing involves testing the drug in animal primarily for excessive toxicity (rat and mice)

IND (investigational new drug) application is filed to FDA for review

If IND approved, clinical trials begin

Phase 1 trials20-100 human volunteersTests drug for safety and drug actionGeneral people are healthy volunteersUsually paid and/or reimbursements

Phase 2 trials100-1,000 peoplePeople with the disease state in questionDetermines minimal dose rangesCan be compensated

Phase 3 trialsInvolves thousands of people with the disease state in questionDosage is pushed to determine max effectivenessInvolves medical centers and major medical centersInvolves IRB’s

After this the NDA (new drug application) is filedFDA review this applicationThousands of pages longRequires scientist, clinician and statistician

preparation and reviewDrug manufacturer submits proposed drug labeling

If the application is approved, marketing of the drug is permitted in the US

Phase IV trialsInvolves post marketing surveillance of drug in the

population at large