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Horizon Sues Apotex to Block Early Launch of Pennsaid 2% Copy

May 16, 2022, 10:09 PM

Horizon Therapeutics Plc filed a lawsuit alleging that Apotex Inc.’s copy of Pennsaid 2% infringes a patent for the topical osteoarthritis treatment because Apotex “has begun or is imminently about to begin” selling it despite a Teva unit’s 180 days of regulatory exclusivity for its generic version.

The Federal Circuit in October 2019 upheld the patent’s validity, rejecting arguments by Teva’s Actavis that it didn’t cover a new idea. The patent, which expires in October 2027, covers a gel formulation that includes diclofenac sodium and is used for topical treatment of pain, such as that from osteoarthritis. ...