India Pharma Outlook Team | Wednesday, 08 April 2026
Aurobindo Pharma has secured a key Aurobindo Pharma USFDA approval to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the U.S.
This Aurobindo Pharma USFDA approval covers four strengths—5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg—marking a significant step in the company’s diabetes portfolio expansion.
The approved product is bioequivalent and therapeutically equivalent to AstraZeneca’s Xigduo XR, a widely prescribed combination therapy for type-2 diabetes. Manufacturing will take place at Unit-IV of APL Healthcare Ltd, a wholly owned subsidiary of Aurobindo, with an immediate launch planned in the U.S. market.
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According to data from IQVIA, the reference product posted an estimated market size of USD 514 million for the 12 months ended February 2026. This highlights a strong near-term revenue opportunity in the U.S. diabetes drug market, especially for combination therapies.
Aurobindo is among the first ANDA applicants with a substantially complete Paragraph IV filing, making it eligible for 180 days of shared generic exclusivity. This gives the company an early-mover advantage in the type-2 diabetes combination therapy segment.
The therapy is used alongside diet and exercise to improve glycemic control in adults with type-2 diabetes where dual treatment is suitable.
With this, Aurobindo’s total approvals from U.S. Food and Drug Administration reach 579 ANDAs, including 554 final and 25 tentative approvals as of March 31, 2026.
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