Tag: patent term restoration
Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible
The Hatch-Waxman Amendments of 1984 created the modern generic drug system in the U.S., slashing approval times and costs while balancing innovation incentives. Today, 90% of prescriptions are filled with generics thanks to this landmark law.
Patent Term Restoration (PTE): How Drug Patents Get Extra Years
Patent Term Restoration (PTE) lets drug makers recover lost patent time due to FDA delays. Learn how it works, who qualifies, why it's controversial, and what's changing in 2025.