Regulatory Approval Details

Aurobindo Pharma Limited received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tofacitinib Tablets in 5 mg and 10 mg strengths. The approval confirms the product as bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz Tablets, 5 mg and 10 mg, of PF Prism C.V.

Manufacturing and Launch Plans

The product will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of the company. The press release states that the product "will be launched immediately" following approval.

Market Size and Commercial Potential

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 approximately US$ 494 million in the U.S. market.

Therapeutic Indications

Tofacitinib Tablets are indicated for:

  • Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate
  • 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)
  • 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

Company ANDA Approval Status

With this approval, Aurobindo Pharma now has a total of 586 ANDA approvals from USFDA, consisting of 561 final approvals and 25 tentative approvals.

Company Background

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 30+ manufacturing and packaging facilities approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company's product portfolio spans seven major therapeutic areas: CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic.