These data files provide digital versions of the US Food and Drug Administration (FDA)'s Orange Book patent and exclusivity tables for years 1985-2016 (no Orange Book was published in 1986). PDF ...

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

The FDA produces "Approved Drug Products with Therapeutic Equivalence Evaluations", commonly referred to as the Orange Book. The Orange Book "identifies drug products approved on the basis of safety ...

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 ...

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.