Tag: Hatch-Waxman Act
Effective Patent Life: Why Market Exclusivity in Pharmaceuticals Is Shorter Than You Think
Effective patent life is often just 10-13 years for new drugs, not the full 20 years. Learn why patents expire faster than you think, how companies stretch exclusivity, and what it means for drug prices and patient access.
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.