Implications of drug price competition and Patent term Restoration Act (DPCPTRA) on Indian pharma industry

The Drug Price Competition and Patent Term Restoration Act (DPCPTRA), informally known as the ‘Hatch-Waxman Act’, introduced in 1984, modified the Patent Act of 1952 and Federal Food, Drug, and Cosmetic Act Section 21 U.S.C. 355(j) to simplify approval process of generic drugs by FDA by filing Abbreviated New Drug Applications (ANDAs). This Act also provided some incentives to innovators as well as generic companies by way of patent extension based on regulatory delays as well as 180-day exclusivity to generic companies that have the first-to-file (FTF) ANDA against patents listed in Orange Book. This paper reports the first-time generic drugs approved by FDA during 2004-08 and the number of ANDAs receiving 180-day exclusivities as well as the impact of DPCPTRA on Indian pharma industry.