The Federal Circuit Court holds exclusive authority over U.S. pharmaceutical patent cases, shaping when generics enter the market, how patents are enforced, and how drug prices are affected. Its rulings on ANDA filings, dosing patents, and standing have major real-world impacts.
The FDA approves generic drugs through the ANDA pathway under the Hatch-Waxman Act, ensuring they match brand-name drugs in safety, strength, and bioequivalence. Learn how the legal and scientific process makes generics affordable without compromising quality.