Tag: Hatch-Waxman Act
Patent Term Restoration (PTE): How Drug Patents Get Extra Time
Patent Term Restoration lets drug makers recover time lost during FDA approval. Learn how the Hatch-Waxman Act works, who qualifies, and why it keeps drug prices high.
When Do Drug Patents Expire? Understanding the 20-Year Term and Real-World Timeline
Drug patents last 20 years from filing, but most drugs face generic competition in 7-12 years due to FDA approval delays. Patent extensions, regulatory exclusivity, and layered patents shape when prices drop.
First Generic vs Authorized Generic: When Timing Changes Everything in Drug Pricing
First generics were meant to drive down drug prices-but authorized generics, launched by brand manufacturers on the same day, are undercutting them. Here’s how timing changes who wins and who pays.