Tag: Paragraph IV certification
Paragraph IV Certification: How Generic Drugs Challenge Patents and Enter the Market
Learn how Paragraph IV certification under the Hatch-Waxman Act allows generic drugs to challenge patents and enter the market early, lowering costs for consumers.
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
The first generic drug filer gets 180 days of market exclusivity under U.S. law to encourage patent challenges. But loopholes let some companies delay competition-costing patients billions. Here’s how it works and why reform is coming.