Aurobindo Pharma has received final approval from the US Food and Drug Administration to manufacture and sell Tofacitinib Tablets in 5 mg and 10 mg doses, a generic version of Pfizer’s branded rheumatoid arthritis drug Xeljanz, the company announced via an exchange filing.
The approval, announced on June 4, adds a significant product to the company’s US generics business. The drug will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of Aurobindo, and the company said it intends to launch the product immediately.
A large market opportunity
According to IQVIA moving annual total data for the twelve months ending April 2026, the US market for Tofacitinib Tablets across both strengths is estimated at approximately $494 million.
Tofacitinib belongs to a class of drugs known as JAK inhibitors and is indicated for three conditions. This includes moderately to severely active rheumatoid arthritis in adults who have not responded adequately to methotrexate, active psoriatic arthritis in patients who have not responded to methotrexate or other disease-modifying antirheumatic drugs, and moderately to severely active ulcerative colitis in patients who are intolerant to or have not responded to TNF blockers.
The reference listed drug, Xeljanz, is marketed by PF Prism C.V., a Pfizer entity.
Building out the ANDA portfolio
The approval brings Aurobindo’s total count of Abbreviated New Drug Application approvals from the USFDA to 586, comprising 561 final approvals and 25 tentative approvals, the company said.
The company, listed on both the NSE and BSE, is among India’s larger generic pharmaceutical exporters to the United States. Its manufacturing network spans over 30 facilities approved by regulators including the USFDA, the UK’s MHRA, the WHO, Japan’s PMDA, and Brazil’s ANVISA, among others.
About Aurobindo Pharma
Aurobindo is headquartered in Hyderabad and operates across more than 150 countries, selling generic pharmaceuticals, branded speciality drugs, and active pharmaceutical ingredients. As per the company, its therapeutic focus areas include central nervous system drugs, anti-retrovirals, cardiovascular medicines, antibiotics, gastroenterological treatments, anti-diabetics, and anti-allergics.
