The approved drug is a generic version of AstraZeneca’s Xigduo XR and will be produced at the company’s Unit-IV facility of APL Healthcare, a wholly owned subsidiary. The company said the product will be launched immediately.
The combination therapy is indicated as an adjunct to diet and exercise to improve glycaemic control in adults where treatment with both medicines is appropriate.
According to IQVIA data, the approved product has an estimated market size of $514 million for the twelve months ending February 2026.
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Aurobindo also said it is eligible for 180 days of shared generic exclusivity as one of the first applicants to file for the drug.
As of March 31, 2026, the company had a total of 579 ANDA approvals from the USFDA, including 554 final approvals and 25 tentative approvals.
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