Tag: Paragraph IV certification

FDA's 180-Day Exclusivity: Benefits, Risks, and Future for Generic Drug Applicants

FDA's 180-Day Exclusivity: Benefits, Risks, and Future for Generic Drug Applicants

Explore the FDA's 180-day exclusivity for generic drugs. Learn how it works, the financial benefits for first movers, risks of forfeiture, and upcoming regulatory reforms affecting the pharmaceutical market.

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180-Day Exclusivity and Authorized Generics: Legal Risks and Real-World Impact

180-Day Exclusivity and Authorized Generics: Legal Risks and Real-World Impact

The 180-day exclusivity rule was designed to reward generic drug companies for challenging patents-but authorized generics let brand-name companies undercut them legally. This is how the loophole works, why it’s hurting competition, and what’s being done to fix it.

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