Tag: Hatch-Waxman Act
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ANDA Process: Legal Requirements for Generic Drug Approval in the U.S.
The ANDA process enables generic drug approval in the U.S. by proving equivalence to brand-name drugs without clinical trials. Legal requirements include bioequivalence, CMC compliance, patent certifications, and FDA user fees under the Hatch-Waxman Act.
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Why Brand Companies Launch Authorized Generics: The Real Strategy Behind the Move
Brand companies launch authorized generics not to give away profits, but to control the market after patent expiry. These identical drugs let them keep revenue, block competitors, and keep patients loyal - all while lowering prices.