Tag: Orange Book
Pediatric Exclusivity: How the FDA Extends Market Protection for Drug Companies
Pediatric exclusivity gives drugmakers six extra months of market protection after they study their medicines in children. It doesn't extend patents-but it blocks generics anyway. Here's how it works.
Hatch-Waxman Act: How U.S. Law Makes Generic Drugs Affordable and Accessible
The Hatch-Waxman Act revolutionized U.S. drug access by creating a fast-track path for generic drugs while protecting brand innovation. It's why 90% of prescriptions are now filled with affordable generics.