Aurobindo Pharma has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tofacitinib Tablets, 5 mg and 10 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz Tablets, 5 mg and 10 mg, of PF Prism C.V.
The product will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of the company and will be launched immediately. According to IQVIA MAT data for the twelve months ending April 2026, Tofacitinib Tablets, 5 mg and 10 mg have an estimated market size of around $494 million in the US. The company now has a total of 586 ANDA approvals (561 final approvals and 25 tentative approvals) from USFDA.
Tofacitinib Tablets are indicated for: i) the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, ii) the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs), iii) the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
