Tag: Paragraph IV certification

Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
The first generic drug filer gets 180 days of exclusive market rights under U.S. law. But this rule, meant to speed up affordable drugs, is now being used to delay competition. Here’s how it works-and why it’s changing.
How Paragraph IV Patent Challenges Speed Up Generic Drug Entry
How Paragraph IV Patent Challenges Speed Up Generic Drug Entry
Paragraph IV certification under the Hatch-Waxman Act lets generic drugmakers challenge brand patents before they expire, speeding up affordable drug access. Learn how it works, why it succeeds, and how big pharma fights back.