Tag: Hatch-Waxman
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
The first generic drug company to file a patent challenge gets 180 days of exclusive sales - but this rule is often exploited to delay cheaper drugs. Here's how it works, who benefits, and why reform is overdue.
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.