Tag: first generic filer

Nov, 26 2025
Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

The first generic drug company to file an ANDA with a Paragraph IV certification gets 180 days of market exclusivity-a powerful incentive under the Hatch-Waxman Act. But loopholes let some companies delay launches, blocking competition and keeping prices high.

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