In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation ...

Megan Chacon, Madelyn McCormick, Evan Sumner Ph.D. For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic ...

Two appeals came from the Federal Circuit regarding the court’s application of Hatch-Waxman’s safe harbor ... provision applies when the infringing act, here the importation of Meril’s ...

Under provisions in the Hatch-Waxman Act, the FDA permits marketing of generics for older indications that no longer have patent protection, even if the brand-name drug develops new, patented uses.

A U.S. Postal Service letter carrier's campaign for Rockford City Council is raising questions about a 1939 law that ...

During his time in Congress, Waxman used legislative tools to unmask the tobacco industry after years of deception and authored the Affordable Care Act, which has helped 20 million more Americans get ...

The company also asserts that, under the Hatch-Waxman Act, Liquidia’s decision to file an amendment instead of a new NDA allowed it to avoid a potential 30-month stay on approval for PH-ILD.