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Tag: generic drug approval

Paragraph IV Patent Challenges: How Generic Makers Challenge Brands
By : Gabrielle Strzalkowski 14 May 2026

Paragraph IV Patent Challenges: How Generic Makers Challenge Brands

Discover how generic drug manufacturers use Paragraph IV certifications to challenge brand-name patents under the Hatch-Waxman Act. Learn about the 180-day exclusivity, FDA approval timelines, and the economic impact on drug prices.

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