Tag: Hatch-Waxman Act

Patent Term Restoration (PTE): How Drug Patents Get Extra Time
Joseph Michael Thompson by Joseph Michael Thompson

Patent Term Restoration (PTE): How Drug Patents Get Extra Time

20 Mar, 2026

Patent Term Restoration lets drug makers extend their patents to make up for FDA approval delays. Learn how it works, who qualifies, and why it's both vital and controversial in the pharmaceutical industry.

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Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence Ratings
Joseph Michael Thompson by Joseph Michael Thompson

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

24 Dec, 2025

The Orange Book is the FDA's official database of approved generic and brand-name drugs with therapeutic equivalence ratings. It helps pharmacists, doctors, and patients identify interchangeable medications and predict when generics will become available, saving billions annually.

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