Tag: Hatch-Waxman Act

29 January 2026 12 Comments Tessa Marley

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

The Orange Book is the FDA's official list of approved drugs with therapeutic equivalence ratings. It enables generic drug competition, saves billions annually, and helps patients access affordable medications.

22 January 2026 12 Comments Tessa Marley

Why Brand Companies Launch Authorized Generics: Strategy Explained

Brand companies launch authorized generics to keep revenue after patent expiration. These are exact copies of their branded drugs sold at lower prices - a smart move that lowers costs for patients and keeps the manufacturer in the game.

17 January 2026 15 Comments Tessa Marley

Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible

The Hatch-Waxman Act of 1984 revolutionized U.S. drug policy by creating the modern generic drug approval system. It cut costs, boosted access, and balanced innovation with affordability-changing healthcare for millions.