Tag: Hatch-Waxman Act

Patent Term Restoration (PTE): How to Extend Patent Life for Drugs and Medical Devices

Patent Term Restoration (PTE) lets drug and device makers recover patent time lost during FDA approval. Learn how it works, who qualifies, and why documentation is everything.

Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence

The Orange Book database is the FDA's official list of approved drugs with therapeutic equivalence ratings and patent information. It determines when generic drugs can enter the market, saving billions in healthcare costs.