A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient.
A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use.In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies.
In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.
The US generics market was estimated at US$18.1 billion in 2004; the leading European generics markets together totalled between US$10 US$11 billion for the same period. This new report asks why there is such a difference in value.
Contrasts in regulatory systems, legislative background and market characteristics increase the difficulties for companies from one area who are trying to enter another market. US and European Prescription Generic Markets reviews these divergent characteristics and also looks at those areas where the two sides are moving closer together.