Tag: FDA approval

The Hatch-Waxman Act created the modern system for generic drugs in the U.S., balancing innovation and affordability. It let generics enter faster while giving brand companies patent extensions-saving billions but also opening the door to abuse.

Complex generic drugs face major scientific and regulatory hurdles that make approval far harder than for simple generics. Despite high demand and patent expirations, few reach the market due to technical challenges, unclear FDA guidance, and high development costs.