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Trump's Budget Request To Include ANDA Exclusivity Changes

 
• By Derrick Gingery

180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.

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President Trump plans to propose changes to the generic drug exclusivity provisions in the Hatch-Waxman Act that could compress the time before a first generic faces competitors on the market.

In his fiscal year 2019 budget request, expected to be released Feb. 12, Trump will propose the 180-day exclusivity period...

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