The appellate court order stems from a case brought by Teva against drugmaker Amneal Pharmaceuticals (NYSE: AMRX) after the latter sought Food and Drug Administration (FDA) approval to bring a generic ...
Teva Pharmaceuticals failed to convince a U.S. appeals court on Friday to reverse a decision that would remove patents related to its ProAir HFA inhaler ... to provide free generic EpiPens to ...
ProAir HFA inhaler from the Food and Drug Administration’s Orange Book. Amneal plans to market a generic version of the inhaler and had argued that Teva’s patents were incorrectly included on ...
The Federal Circuit's recent ruling that patents listed in the FDA's Orange Book must cover the active ingredient of a drug has sparked significant debate in the pharmaceutical industry. The court's ...
The U.S. Federal Trade Commission, which has warned pharmaceutical companies against submitting irrelevant patents to the FDA to limit generic ... inhaler device and "do not claim or even mention ...