Tag: ANDA

History of Generic Drugs in the United States: How Cheaper Medicines Became the Norm

History of Generic Drugs in the United States: How Cheaper Medicines Became the Norm

Generic drugs now make up over 90% of U.S. prescriptions but cost only 23% of total drug spending. Learn how the Hatch-Waxman Act and FDA regulations turned generics from rare exceptions into the backbone of affordable medicine.

Hatch-Waxman Act: How Federal Law Shapes Generic Drug Approval in the U.S.

Hatch-Waxman Act: How Federal Law Shapes Generic Drug Approval in the U.S.

The Hatch-Waxman Act created the legal framework for generic drug approval in the U.S., saving billions in healthcare costs. Learn how ANDAs, the Orange Book, and patent challenges make generics possible.