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Tag: Hatch-Waxman Act

30-Month Stay: How Patent Litigation Delays Generic Drug Approval
20 November 2025 14 Comments Maya Tillingford

30-Month Stay: How Patent Litigation Delays Generic Drug Approval

The 30-month stay under the Hatch-Waxman Act delays generic drug approval by freezing FDA approval during patent litigation. Learn how this legal tool is used - and abused - to block cheaper medications, costing billions annually.

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