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Feb 2, 2026

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Patents

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Patents

by Ray Fothergill

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Paragraph IV certifications let generic drug makers legally challenge brand-name patents before launch. This Hatch-Waxman Act tool has saved over $1.7 trillion in healthcare costs and drives competition in the U.S. drug market.

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