Tag: tentative approval

Tentative Approval and Litigation: How Generic Drug Makers Wait for Market Entry
Rob Visor
4 Dec 2025
Tentative Approval and Litigation: How Generic Drug Makers Wait for Market Entry

Tentative approval from the FDA lets generic drug makers prepare for market entry before patents expire, but litigation and timing mistakes can cause costly delays. Learn how the Hatch-Waxman Act shapes the race to bring affordable drugs to patients.

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