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The Hatch-Waxman Act (Abbreviated NDA)

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This paper provides an overview of the modern US generic drug industry evolution after the Hatch-Waxman Act of 1984, considered one of the most significant legislation impacting generic drug approval to the US pharmaceutical market.
In the early 1980s, there were very few generic drug products in the US market. Although the Federal Food, Drug, and Cosmetic Act (FD&C Act) made it possible to gain generic drugs approval via the “paper new drug application (NDA)”, it was still difficult for generic companies due to insufficient scientific literature published by innovator companies that supported justification of safety and efficacy. In response, the Hatch-Waxman Act was negotiated and amended the FD&C Act by creating an Abbreviated NDA (ANDA) for approval of a generic drug by the FDA on the basis of bioequivalence – clinically showing the same efficacy and safety as the reference product. …show more content…
To protect innovator companies, the Hatch-Waxman Act allowed extending the patent life of a drug by a portion of time taken for the FDA regulatory review. The Act required the FDA to publicly lists the patents for approved drug products in the Orange Book with therapeutic equivalence evaluations provided by the drug innovator. The Act incentivized generic companies by rewarding the first company filing ANDA containing a paragraph IV certification (a patent challenge) with 180-day marketing exclusivity if their ANDA is successfully approved. The FDA cannot approve another generic during that 180

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