Pharma gyan Pandit

Brand name & generic drugs

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 like Calpol, Crocin, Tylenol. The brand name is Calpol, Crocin, 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.

When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.

Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product. 

The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.

Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.

All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.

Cheaper does not mean lower quality. 

Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.