Tag: ANDA
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.
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.