The U.S. FDA has given tentative approval to Sandoz (OTCQX:SDZNY) for a generic version of Pfizer’s (NYSE:PFE) kidney cancer drug Inlyta (axitinib).
The tentative approvals are for both the 1 mg and 5 mg tablets.
The axitinib generic cannot be launched immediately doing to patent litigation filed in November 2024 by Pfizer against Sandoz (OTCQX:SDZXF) alleging that a key Inlyta patent is infringed. That patent expires in June 2031.