Tag: Hatch-Waxman Act
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.
Patent Term Restoration (PTE): How It Extends Drug Patent Life
Patent Term Restoration (PTE) lets pharmaceutical and medical device companies recover time lost during FDA approval. Learn how it works, who qualifies, and why it’s critical - and controversial - for drug pricing.