Tag: Hatch-Waxman Act
Generic Drug Shortages: Why Manufacturing Constraints Create Scarcity
Explore why generic drug shortages persist despite high demand. From global supply chain dependencies to economic pressures, discover the manufacturing constraints impacting your medication access.
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.