Pfizer suing Aurobindo over generic Xeljanz

Pfizer has asked a Delaware federal court to block Aurobindo Pharma from moving forward with its plans to market a generic version of Pfizer's arthritis drug Xeljanz (tofacitinib).

Pfizer is claiming that the proposed generic versions of the arthritis drug’s 5-mg and 10-mg tablets will infringe two patents.

According to the complaint, filed Jan. 11, Pfizer is seeking a court order blocking copies until the patents have expired, which according to the supplemental filing expires in March 2023 and December 2025.

In December 2018, Pfizer sued Teva over a patent that covers the 11 mg tablets of Xeljanz XR; a bench trial for that case, also in Delaware, is set for January 2022.

In September last year, the FDA approved Xeljanz for treating children/adolescents age 2 and older with active polyarticular course juvenile idiopathic arthritis. 

In November, Aurobindo sent a letter to Pfizer notifying it that it had filed its abbreviated application seeking approval to market and sell generic copies of Xeljanz before the expiration of the ’027 and RE’783 patents. It also alleged that the ’027 and RE’783 patents “are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale” of the generic drugs.