In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...

In an attempt to curb inaccurate patent listings in the Food and Drug Administration’s “Orange Book,” a list of drugs the FDA has deemed safe and effective, the Federal Trade Commission has ...

with the U.S. Food and Drug Administration (FDA). The petition formally requests correction of the Orange Book listings for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets to accurately reflect the ...

Teva insisted panel’s narrow interpretation of ‘claims the drug’ will have a seismic effect on the Orange Book | Stay granted while en banc rehearing is under question | Decision could reshape patent ...

On December 20, 2024, the US Court of Appeals for the Federal Circuit released its opinion in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, affirming a lower court decision ...

In the Notice Letter in January 2023, Teva stated that it intended to market a generic version of Firdapse before the expiration of multiple of Catalyst’s patents listed in the FDA Orange Book.