Tag: Hatch-Waxman Act

Patent litigation in generic drug markets is delaying affordable medicines by years. With serial lawsuits, improper patent listings, and complex settlements, patients pay billions more than they should. Here’s how the system works - and why it’s broken.

Paragraph IV certifications let generic drug companies challenge brand-name drug patents before launch, speeding up affordable medicine access. This legal tool under the Hatch-Waxman Act has saved consumers trillions since 1984.

An ANDA is the FDA application that allows generic drugs to enter the market without repeating costly clinical trials. It's how 90% of U.S. prescriptions are filled at a fraction of the cost.