Cumberland Pharmaceuticals v. Mylan Institutional LLC, No. 16-1155 (Fed. Cir. Jan. 26, 2017)
From the Opinion
The passage below is extracted verbatim from the opening of the document. It has not been editorially summarized — consult the full opinion for the court's complete reasoning.
Cumberland Pharmaceuticals, Inc. owns U.S. Patent No. 8,399,445, which describes and claims acetylcysteine compositions substantially free of chelating agents. It is listed in the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book ) as covering Cumberland’s chelating - agent-free formulation of Acetadote ®, an intravenous antidote for ov erdoses of acetaminophen.
Source: govinfo.gov USCOURTS collection · retrieved July 23, 2026 · Report an error