Tag: generic drug patents
Jan, 24 2026
Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Patents
Paragraph IV certifications let generic drug makers legally challenge brand-name patents before launch. This Hatch-Waxman Act mechanism saves billions in healthcare costs and drives generic competition in the U.S.
Jan, 24 2026
Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Brand Patents
Paragraph IV certifications let generic drug makers legally challenge brand-name patents before market entry. This Hatch-Waxman Act tool drives competition, saves billions, and offers 180-day exclusivity to winners - but only if they navigate complex legal risks.