The United States Food and Drug Administration has granted final approval to Zydus Lifesciences’ subsidiary Zydus Pharmaceuticals (USA) Inc. for Tofacitinib Tablets, 5 mg and tentative approval for Tofacitinib Tablets, 10 mg (USRLD: Xeljanz Tablets) (USFDA). Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Tofacitinib Tablets, 5 mg, making it eligible for 180 days of shared generic drug exclusivity.
Tofacitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis, as well as adults with active psoriatic arthritis. It is also approved for the treatment of adult patients suffering from moderate to severe active ulcerative colitis (UC). The drug will be manufactured in Moraiya, Ahmedabad, at the group’s formulation manufacturing facility (India).
In the United States, Tofacitinib Tablets (5 mg and 10 mg) had annual sales of USD 900 million (IQVIA MAT Dec. 2022).