Dec 17, 2025
Gastrointestinal Combination Products: Generic Availability and Alternatives
Tag: generic drug approval
30-Month Stay Explained: How Patent Litigation Delays Generic Drug Approval
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Explore how the 30-month stay under the Hatch-Waxman Act delays generic drug approval through patent litigation, impacting costs and market access.
FDA Authorization of Generics: Legal Basis and Approval Process
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The FDA approves generic drugs through a strict legal process based on the Hatch-Waxman Act. Generics must match brand drugs in active ingredients, strength, and bioequivalence - not just cost. Over 90% of U.S. prescriptions are for generics, saving billions annually.
