Tag: Hatch-Waxman Act
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.
Nov, 14 2025
Generic Drug Availability: How Long After Patent Expiration Do They Actually Hit the Market?
Generic drugs don't hit shelves right after patents expire. Legal battles, regulatory delays, and strategic patenting can push availability out by years - costing patients billions. Here's how the system really works.