Aurinia Pharmaceuticals said it reached a settlement with Teva Pharmaceuticals resolving patent litigation over Teva’s planned generic version of Aurinia’s lupus drug LUPKYNIS.
Under the agreement, Teva acknowledged the validity and enforceability of Aurinia’s U.S. Patent Nos. 10,286,036 and 11,622,991, which cover the 7.9 mg oral formulation of voclosporin. The patents are set to expire in December 2037.
Teva secured the right to launch its generic voclosporin product no earlier than December 7, 2036, contingent on U.S. Food and Drug Administration approval. The settlement also resolves related patent disputes involving DifGen Pharmaceuticals, Dr. Reddy’s Laboratories, Hikma Pharmaceuticals, Lotus Pharmaceutical and Sandoz, and Zydus Pharmaceuticals.
Aurinia’s LUPKYNIS was approved by the FDA in January 2021 for treating active lupus nephritis in adults. The company is also developing aritinercept as a potential therapy for autoimmune diseases.
Shares of Aurinia Pharmaceuticals were indicated higher in after-hours trading following the announcement.
