Tag: Hatch-Waxman Act
Multiple Generics: How Competitors Enter After the First Generic Market Entrant
After the first generic enters the market, competitors flood in, triggering dramatic price drops and supply chain instability. Learn how patent rules, PBMs, and manufacturing risks shape the chaotic second phase of generic drug competition.
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What Is an ANDA? The Complete Guide to Abbreviated New Drug Applications
An ANDA is the FDA pathway that lets generic drug makers prove their product works just like a brand-name drug - without repeating costly clinical trials. It's how 90% of U.S. prescriptions are filled at a fraction of the cost.
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Nifedipine and Insomnia: Tips for Better Sleep
27 Mar 2025