RELATED LITERATURE AND STUDIES

A generic drug requires having the same quality and performance as brand name drugs. It also allows a 45 percent difference in the effectiveness of the generic drugs. It also does not allow a 45 percent difference in the effectiveness of the generic drug product. When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product. Cheaper does not mean lower quality because FDA monitors adverse events reports for genre drug and FDA s actively engaged in making all regulated products including generic drugs safer Food and Drug Administration FDA.

A brand name drug is a medicine that’s discovered, developed and marketed by a pharmaceutical company. Once a new drug is discovered, the company files for a patent to protect against other companies making copies and selling the drug. At this point the drug has two names: a generic name that’s the drug’s common scientific name and a brand name to make it stand out in the marketplace. This is true of prescription drugs as well as over-the-counter drugs. An example is the pain reliever Tylenol. The brand name is Tylenol and the generic name is acetaminophen. Generic drugs have the same active ingredients as brand name drugs already approved by the Food and Drug Administration FDA. Generics only become available after the patent expires on a brand name drug. Patent periods may last up to 20 years on some drugs. The same company that makes the brand name drug may also produce the generic version. Or, a different company might produce it Depression and Bipolar Support Alliance –DBSA. (Patricia Camille Fajilan, 2015)

A generic is a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.

Generic drugs are marketed under a non-proprietary or approved name rather than a proprietary or brand name. Generic drugs are frequently as effective as, but much cheaper than, brand-name drugs. For example, paracetamol is a chemical ingredient found in a number of brand-name painkillers, but is also sold as a generic drug not under a brand name. Because of their low price, generic drugs are often the only medicines that the poorest can access. The Trade-Related Aspects of Intellectual Property Rights TRIPS agreement does not prevent governments from requiring accurate labeling or allowing generic substitution. Indeed, it is argued that competition between drug companies and generic producers has been more effective than negotiations with drug companies in reducing the cost of drugs, in particular those used to treat HIV/AIDS.A brand name is a name given to a drug by the manufacturer. The use of the name is reserved exclusively for its owner.

A brand name is a name given to a drug by the manufacturer. The use of the name is reserved exclusively for its owner.

Counterfeit medicine is medicine that is deliberately and fraudulently

mislabeled with respect to identity and/or source. Counterfeiting can apply to

both branded and generic products. Counterfeit products may include

products with the correct ingredients or the wrong ingredients, lacking active

ingredients, with incorrect quantities of active ingredients, or fake packaging

World Health Organization.

Generic drugs are copies of brand-name drugs that have exactly the same

dosage, intended use, effects, and side effects, route of administration, risks,

safety, and strength as the original drug. Brand names are usually capitalized

while generic names are not. A generic drug, one used for hypertension,

ismetoprolol, whereas a brand name for the same drug is Lopressor.The FDA

U.S. Food and Drug Administration requires that generic drugs be as safe and

effective as brand-name drugs. A patent is granted that gives the company

that developed the drug an exclusive right to sell the drug as long as the

patent is in effect. As the patent nears expiration, manufacturers can apply to

the FDA for permission to make and sell generic versions of the drug; and

without the startup costs for development of the drug, other companies can

afford to make and sell it more cheaply. The FDA applies the same standards

for all drug manufacturing facilities, and many companies manufacture both

brand-name and generic drugs. The FDA requires that generic drugs work as

fast and as effectively as the original brand-name products. Sometimes,

generic versions of a drug have different colors, flavors, or combinations of

inactive ingredients than the original medications.