Legislation, generic drugs

History of Generic Drug Legislation in United States... 

This legislation represented a compromise that also allowed easier FDA approval for generic drugs after patent expiration. The law also allows two types of exclusivity not related to patent status—a 5-year exclusivity for new chemical entities not eligible for a patent and a 3-year exclusivity for new uses of approved chemical entities. TMs appendix discusses the 3-year exclusivity in greater detail in the following section. 

Some practices utilized by brand firms to delay generic competition have been the target of recent FTC and legislative actions. One concern was the practice of listing several new patents late in the product life cycle in an apparent effort to trigger successive 30-month stays to delay generic competition. To prevent this practice, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 limited each branded product to one 30-month stay (Padden and lenkins 2004). 

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