generic drug

generic drug, therapeutic substance that is equivalent to a brand-name drug with respect to its intended use, its effects on the body, and its fate within the body.

Every drug has a generic name; most, however, are marketed under a brand name almost exclusively until their patents expire. At that time, other companies may begin manufacturing and selling the generic version. Generic drugs tend to be sold at a much lower price than brand-name drugs, because the companies that manufacture generics bypass the expense of research and development, clinical trials, regulatory approval, and marketing associated with brand-name drugs. The lower price of generic drugs makes them more affordable for health service providers and patients compared with brand-name drugs. The regulation of generic drugs is based mainly on their bioequivalence (degree of similarity) to the original brand-name agents. Generic drugs are required to contain the same active ingredients as the brand-name versions, and they must meet the same requirements for preparation. They also must be of the same strength, use the same route of administration, and have acceptable safety and efficacy profiles.

The manufacture of a generic drug is legal when the patent for the brand-name drug has expired, a patent was never issued, the patent will not be infringed, or the patent is not enforceable in the country where the generic drug is manufactured and sold. A company may also manufacture a generic drug if it can verify that the original brand-name drug patent was invalid or unenforceable. In anticipation of patent expiration, many companies with brand-name drugs create a generic product of their own or license the product to generic companies. Some countries have also allowed their manufacturers to produce generic drugs to treat major diseases when the health services of those countries have not been able to fund the cost of brand-name drugs.