Tag: Hatch-Waxman Act
Patent Litigation and Authorized Generics: Impact on Pharmaceutical Competition
Explore how authorized generics distort pharmaceutical competition by allowing brand owners to undercut independent generics during exclusivity periods, impacting prices and patent litigation outcomes.
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Bioavailability Studies for Generics: What They Test and Why
Discover what bioavailability studies test in generic drug approval. Learn how the FDA uses AUC and Cmax metrics to ensure generics are safe, effective, and equivalent to brand-name medications.
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How FDA Approves Generic Drugs: The ANDA Process Explained
Discover how the FDA approves generic drugs through the ANDA process, ensuring safety and cost savings for millions of Americans.
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Market Exclusivity Extensions: Mechanisms Beyond Patents Explained
Explore how pharmaceutical companies extend monopolies beyond patent expiration using regulatory exclusivity, PTEs, and orphan drug incentives in the US and EU.
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FDA Generic Drug Approval: A Step-by-Step Guide to the ANDA Process
Learn the step-by-step FDA generic drug approval process, from ANDA submission and bioequivalence testing to navigating the Hatch-Waxman Act and GDUFA timelines.
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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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