Tag: 180-day exclusivity

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Brand-Name Patents
Dec 20 2025 Charlie Hemphrey

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Brand-Name Patents

Paragraph IV certifications let generic drug makers legally challenge brand-name patents before launch. This Hatch-Waxman Act tool drives down drug prices by enabling 180-day market exclusivity for the first challenger - but it comes with high legal risks and complex rules.

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