Aurinia Settles Patent Litigation with Teva, Securing U.S. Exclusivity for LUPKYNIS Until 2036
核心洞察
Aurinia Pharmaceuticals and Teva Pharmaceuticals reached a settlement resolving patent litigation over Teva's proposed generic 7.9 mg voclosporin oral capsules.
Teva stipulated that Aurinia's U.S. Patent Nos. 10,286,036 and 11,622,991 are valid, enforceable, and would be infringed by its generic product.
Under the agreement, Teva may not launch its generic voclosporin before December 7, 2036, contingent on FDA approval.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced on August 19, 2026, that it and its subsidiary, Aurinia Pharma U.S., Inc., have entered into a settlement agreement with Teva Pharmaceuticals Inc. (搜索) to resolve patent infringement litigation concerning Teva's filing of an Abbreviated New Drug Application (ANDA) seeking to market a generic 7.9 mg voclosporin oral capsule in the United States.
Under the terms of the settlement, Teva has stipulated that Aurinia's U.S. Patent Nos. 10,286,036 and 11,622,991 — which expire in December 2037 — are enforceable, valid, and would be infringed by commercial sales within the United States of its generic voclosporin product. The settlement further provides that Teva may launch its generic voclosporin product no earlier than December 7, 2036, unless certain defined contingencies occur earlier. Teva's ability to market its generic voclosporin product in the United States will also be contingent on obtaining approval from the United States Food and Drug Administration (FDA).
Ongoing Litigation Against Other Generic Filers
Aurinia's related patent infringement actions continue against each of 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, in the United States District Court for the District of New Jersey.
About LUPKYNIS and Aurinia's Pipeline
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (搜索). Aurinia is also developing aritinercept (搜索), a dual inhibitor of B cell-activating factor (BAFF (搜索)) and a proliferation-inducing ligand (APRIL (搜索)) for the potential treatment of autoimmune diseases.