180-Day Exclusivity Changes Pushed In Biden’s Budget Proposal

The legislative proposal would make first-filer exclusivity function similar to the competitive generic therapy program, allowing additional approvals if the commercial launch is delayed.

No ANDA parking
The FDA still wants to crack down on generic exclusivity "parking." • Source: Nielsen Hobbs; the Pink Sheet | Alamy, Shutterstock images

The Biden administration is attempting to revive a proposal that it argues would speed approvals of ANDAs and drive “significant cost savings” but that generic firms worry would upend their business model and erode one their most valuable incentives.

Included among the legislative proposals in the US Food and Drug Administration’s fiscal year 2023 budget request congressional justification,...

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