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Tag: ANDA filing

First Generic Entry: Why the First Filer Gets 180-Day Exclusivity

First Generic Entry: Why the First Filer Gets 180-Day Exclusivity

3 Aug
Medications Peyton Holyfield

Discover why the first generic drug filer receives 180-day exclusivity under the Hatch-Waxman Act. Learn how Paragraph IV certifications, patent challenges, and FDA rules shape the generic drug market.

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