Tag: FDA ANDA

30-Month Stay: How Litigation Delays Generic Drug Approval
19 Jan

30-Month Stay: How Litigation Delays Generic Drug Approval

by Prudence Bateson Jan 19 2026 11 Pharmaceuticals

The 30-month stay under the Hatch-Waxman Act delays generic drug approval by locking in patent litigation, often for years after patents expire. Learn how it works, who benefits, and why it's under fire.

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