The Federal Circuit opinion was authored by Judge Prost and joined by Judges Taranto and Hughes.

Precedential and Key Federal Circuit Opinions - TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW ...

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 ...

The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims did not “claim the drug that was approved” or ...

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 ...

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.