The Hatch-Waxman Act balances brand patent protection with generic drug competition. Learn how the ANDA process, Orange Book listings, and 180-day exclusivity rules drive down medication costs for millions of Americans.
Landmark court decisions in generic patent law shape drug prices and access. Key rulings like Amgen v. Sanofi and Allergan v. Teva define how generics challenge patents, use the Orange Book, and navigate the Hatch-Waxman Act-impacting millions of patients.