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What is the Hatch Waxman Act and what does it mean for generics?

April 26, 2017ACT generics hatch mean waxman

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What is the Hatch Waxman Act and what does it mean for generics?

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The 1984 Drug Price Competition and Patent Term Restoration Act of 1984 is commonly known as the Hatch Waxman Act. On the one hand, it introduced a five-year period of data exclusivity for innovative medicines in the US. On the other hand, it simplified the approval process for generics.