Tag: Hatch-Waxman Act

11 Feb

Future Role of Authorized Generics: Market Outlook

by Melissa Kopaczewski Feb 11 2026 0 Pharmaceuticals

Authorized generics let brand manufacturers sell their own drugs under a generic label after patent expiration. As more high-revenue drugs lose exclusivity, this strategy is evolving - with faster FDA approvals and a shift toward U.S.-made production changing how they impact prices and competition.

30-Month Stay: How Litigation Delays Generic Drug Approval

by Prudence Bateson Jan 19 2026 11 Pharmaceuticals

The 30-month stay under the Hatch-Waxman Act delays generic drug approval by locking in patent litigation, often for years after patents expire. Learn how it works, who benefits, and why it's under fire.

Cost Comparison: Authorized Generics vs First-to-File Generics in the U.S. Drug Market

by philip onyeaka Jan 9 2026 13 Pharmacy Savings

Authorized generics and first-to-file generics both cut drug costs, but authorized generics drive deeper price drops during the critical 180-day exclusivity window. Learn how they compare and how to save more on prescriptions.