Aurinia settles patent dispute with Teva over generic voclosporin
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has reached a settlement with Teva Pharmaceuticals Inc. to resolve patent infringement litigation related to Teva's application to market a generic version of voclosporin 7.9 mg oral capsules in the United States.
Under the settlement terms, Teva acknowledged that Aurinia's U.S. Patent Nos. 10,286,036 and 11,622,991, both expiring in December 2037, are valid, enforceable, and would be infringed by commercial sales of its generic voclosporin product in the United States. Teva agreed not to launch its generic product before December 7, 2036, unless certain defined contingencies occur. Any commercial launch will also require FDA approval.
Aurinia's patent infringement actions against several other generic drug makers continue in the U.S. District Court for the District of New Jersey. The remaining defendants include DifGen Pharmaceuticals LLC, Dr. Reddy's Laboratories Inc. and its affiliate, Galenicum Health S.L.U., Hikma Pharmaceuticals USA Inc., Lotus Pharmaceutical Co. Ltd. and its affiliate, Sandoz Inc., and Zydus Pharmaceuticals (USA) Inc. and its affiliate.
Voclosporin is marketed by Aurinia under the brand name Lupkynis and is approved by the FDA for the treatment of adult patients with active lupus nephritis.
