Tag: Hatch-Waxman Act
FDA Safety Alerts: Understanding Communications About Generic Drug Problems
Explore how FDA safety alerts work for generic drugs, the labeling gaps caused by the Hatch-Waxman Act, and what patients need to know about MedWatch and bioequivalence.
Why Brand Companies Launch Authorized Generics: Strategy Explained
Brand companies launch authorized generics not to lose money, but to keep it. By selling their own exact drug at generic prices, they prevent total revenue collapse when patents expire - and keep patients on trusted medications.
30-Month Stay: How Patent Litigation Delays Generic Drug Approval
The 30-month stay under the Hatch-Waxman Act delays generic drug approval by freezing FDA approval during patent litigation. Learn how this legal tool is used - and abused - to block cheaper medications, costing billions annually.
