Aurinia Pharmaceuticals Inc. shares declined 2% in after-hours trading on Wednesday after the company announced a patent settlement with Teva Pharmaceuticals Inc. regarding the generic version of voclosporin.
The agreement permits Teva to introduce its generic 7.9 mg voclosporin oral capsules no earlier than December 7, 2036, contingent on FDA approval and the absence of defined contingencies. Teva acknowledged that Aurinia’s U.S. Patent Nos. 10,286,036 and 11,622,991—set to expire in December 2037—are enforceable, valid, and would be infringed by commercial sales of the generic product in the U.S.
The settlement resolves litigation stemming from Teva’s filing of an Abbreviated New Drug Application for the generic version of the drug, which is marketed under the brand name LUPKYNIS. LUPKYNIS, the first FDA-approved oral therapy for adult patients with active lupus nephritis, received approval in January 2021.
The dispute involved multiple generic drugmakers, including DifGen Pharmaceuticals LLC, Dr. Reddy’s Laboratories Inc., Galenicum Health S.L.U., Hikma Pharmaceuticals USA Inc., Lotus Pharmaceutical Co. Ltd., Sandoz Inc., Zydus Pharmaceuticals (USA) Inc., and its affiliate. The resolution removes uncertainty over Teva’s market entry timeline while maintaining Aurinia’s patent protections through late 2037.
