generic product

A generic product is a copy of a previously branded medicine, sold under the drug's own name rather than a brand name, after the originator's patent has expired. When a blockbuster's patent lapses, other manufacturers may legally make the same drug, usually much more cheaply.

To be approved, a generic must contain the same API at the same strength in the same dosage form by the same route, and must demonstrate bioequivalence — that it delivers the drug to the bloodstream at essentially the same rate and extent as the original. Its excipients, shape and colour may differ, but its clinical performance should not.

Generics drive down medicine costs enormously without sacrificing quality, since they meet the same pharmacopoeial and manufacturing standards as branded products. A common misunderstanding is that generics are weaker or inferior; in fact a well-approved generic is held to the same therapeutic standard, differing mainly in price, appearance and inactive ingredients.