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Tag: patent challenge

Paragraph IV Certifications: How Generic Drug Companies Challenge Patents Early

Paragraph IV Certifications: How Generic Drug Companies Challenge Patents Early

Caspian Mortensen Dec, 2 2025 4

Paragraph IV certifications let generic drug makers challenge brand patents before they expire. Under the Hatch-Waxman Act, this legal tool speeds up affordable drug access, saves billions annually, and drives competition - despite patent thickets and pay-for-delay deals.

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