Tag: Hatch-Waxman Act

The Hatch-Waxman Act transformed U.S. drug access by creating a legal path for generic drugs to enter the market. It saved trillions, cut prices, and made medicines affordable-while still protecting innovation.

Patent Term Restoration (PTE) lets drugmakers recover lost patent time due to FDA delays. Learn how it works, who qualifies, why it's controversial, and what's changing in 2025.

Patent litigation in generic drug markets delays affordable medicines, with brand companies using Orange Book listings, serial lawsuits, and pay-for-delay settlements to extend monopolies. Here’s how the system works-and why patients pay the price.