Nov 26, 2025
How TRIPS Patent Rules Shape Global Access to Generic Medicines
Tag: Hatch-Waxman Act
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.
Cost Comparison: Authorized Generics vs First-to-File Generics
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Authorized generics and first-to-file generics both lower drug costs, but when they compete, prices drop even more. Learn how these two types of generics affect your prescription bills and why competition matters.
