Tag: Paragraph IV certification
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
Posted by Ellison Greystone on Mar, 20 2026
The first generic drug company to file an ANDA with a Paragraph IV certification gets 180 days of market exclusivity under U.S. law. This incentive drives competition, lowers drug prices, but is often exploited to delay generic entry.