Tag: Paragraph IV certification
Paragraph IV Certifications: How Generic Drug Companies Challenge Patents Early
Caspian Mortensen Dec, 2 2025 4Paragraph 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.
More Detail