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Duexis® (ibuprofen / famotidine)
Case Name:
Horizon Medicines LLC v. Alkem Labs. Ltd., No. 18-1014-RGA, 2020 WL 7022591 (D. Del. Nov. 30, 2020) (Andrews, J.)
Drug Product and Patent(s)-in-Suit: Duexis® (ibuprofen / famotidine); U.S. Patent No. 8,067,033 (“the ’033 patent”)
Nature of the Case and Issue(s) Presented: Duexis® is a tablet formulation indicated for relief from rheumatoid arthritis/osteoarthritis and is intended to decrease the risk of developing upper-gastrointestinal ulcers. The ’033 patent recited a pharmaceutical composition comprising (i) a first portion with 800 mg ibuprofen, (ii) a second portion with 26.6 mg famotidine, (iii) no more than 1% sulfamide, (iv) certain stability requirements, and (v) three-times-a-day dosing. The court presided over a bench trial, considered the parties’ post-trial briefs, and found that claims 1, 8, 11, and 14 of the ’033 patent were invalid for obviousness and not infringed. The court further found that the assert