Tag: Hatch-Waxman Act
Caroline Wagstaff
Jan
29
29
Hatch-Waxman Amendments: How Landmark Law Created the Modern Generic Drug Market
The Hatch-Waxman Act of 1984 created the modern generic drug system in the U.S., balancing innovation incentives with affordable access. It cut approval costs by 90%, boosted generic use to 90% of prescriptions, and sparked ongoing debates over patent abuse and drug pricing.
Caroline Wagstaff
Jan
8
8
How Paragraph IV Patent Challenges Speed Up Generic Drug Entry
Paragraph IV certification under the Hatch-Waxman Act lets generic drug makers challenge brand-name patents to speed up affordable drug access. Learn how it works, why it succeeds - and why some drugs stay expensive.
