Tag: Paragraph IV certification
Generic Patent Case Law: Landmark Court Decisions Shaping Drug Prices
Explore how landmark court decisions like Amgen v. Sanofi shape generic patent case law, impacting drug prices and availability. Learn about Hatch-Waxman, Orange Book listings, and the rise of IPRs.
FDA's 180-Day Exclusivity: How It Helps First Generic Drug Makers Compete
The FDA's 180-day exclusivity gives the first generic drug maker a head start to challenge patents and bring down prices. But loopholes let companies delay launches-costing patients billions. Here's how it works-and why reform is coming.