By: IPP Bureau
Last updated : June 05, 2026 9:26 am
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Tofacitinib Tablets in 5 mg and 10 mg strengths, the generic equivalent of Xeljanz Tablets developed by PF Prism C.V.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz, and will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of Aurobindo Pharma.
The company announced that the product will be launched in the United States immediately.
Tofacitinib is an oral Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
It is also approved for adult patients with active psoriatic arthritis who have not responded adequately to methotrexate or other disease-modifying antirheumatic drugs (DMARDs), as well as for adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to TNF blockers.
According to IQVIA MAT data for the 12-month period ending April 2026, the U.S. market for Tofacitinib Tablets, 5 mg and 10 mg, is estimated at approximately $494 million, presenting a significant commercial opportunity for the company.