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Tag: ANDA

Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
By Cedric Mallister 3 Feb 2026

Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market

The first generic filer gets 180 days of exclusivity under the Hatch-Waxman Act to encourage patent challenges and lower drug prices. But loopholes let some companies delay launches, blocking competition and keeping prices high.

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