Aurinia Pharmaceuticals (AUPH) has reached a patent infringement settlement with Teva Pharmaceuticals (TEVA) over its flagship lupus drug Lupkynis (voclosporin).
The deal should prevent Teva from launching a generic version of voclosporin in the United States until December of 2036, providing Aurinia with a significant window of market protection.
The settlement terms remain in place unless “certain defined contingencies occur earlier,” Aurinia confirmed in a release, and also assumes Teva will secure FDA approval of its generic version.
Investors responded positively to the news, with Aurinia’s share price climbing 7% on Thursday as the deal provided greater clarity on the company’s exclusivity timeline.
This is not the first patent infringement case Aurinia has resolved in connection with Lupkynis, which received FDA approval back in 2021.
In 2023, the company settled with India’s Sun Pharma, with both parties agreeing to file a joint motion to terminate an ongoing Inter Partes Review directed at Aurinia’s original patent for voclosporin.
That arrangement came in exchange for Aurinia dropping a patent infringement challenge related to Sun’s branded dry eye disease eye drops Cequa.
An Inter Partes Review is a re-examination conducted by the U.S. Patent and Trademark Office to assess whether a patent is valid, and can be initiated by third parties based on prior art as a lower-cost alternative to full patent infringement litigation.
Despite the Teva resolution, Aurinia confirmed it remains in ongoing patent infringement litigation with generics players DifGen, Dr. Reddy’s, Hikma, Sandoz, and Zydus, with each case being handled in U.S. District Court in New Jersey.
Protecting exclusivity over Lupkynis carries enormous commercial weight for Aurinia, as the calcineurin inhibitor remains the Canada-based company’s only marketed product.
Earlier this month, the company reported first-half 2026 revenue of $161 million, representing a 21% increase year over year, demonstrating the drug’s continued commercial momentum.
Aurinia also guided to full-year 2026 revenue of between $315 million and $325 million, signalling confidence in Lupkynis’s sustained market performance through the rest of the year.
In the competitive lupus treatment landscape, Aurinia faces pressure from blockbuster therapies including GSK’s Benlysta and Roche’s Gazyva, as well as AstraZeneca’s Saphnelo, which was also approved in 2021 and generated sales of $483 million last year.