Tag: Paragraph IV certification
180-Day Exclusivity: How Patent Law Shapes Generic Drug Market Entry
Explore how 180-day exclusivity under the Hatch-Waxman Act incentivizes generic drug companies to challenge patents and impact market pricing.
FDA's 180-Day Exclusivity: How First Generic Applicants Gain Market Advantage
FDA's 180-day exclusivity gives the first generic drug applicant a legal edge to launch without competition-but loopholes let companies delay entry. Here's how it works, who benefits, and why reform is urgent.