Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride extended-release tablets in multiple strengths such as 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg.
The approved formulation is bioequivalent and therapeutically equivalent to the reference listed drug, Xigduo XR Tablets, originally marketed by AstraZeneca.
Immediate launch from APL Healthcare facility
According to the company, the product will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma. The company has indicated that commercial launch will follow immediately, enabling it to tap into the US market without delay.
Strong market opportunity
The approved product addresses a sizeable market opportunity, with an estimated market size of $514 million for the 12 months ended February 2026, as per IQVIA MAT data. The approval further strengthens Aurobindo Pharma’s presence in the US generics space.
Exclusivity advantage boosts competitive position
Aurobindo Pharma is among the first Abbreviated New Drug Application (ANDA) applicants to submit a substantially complete filing with a Paragraph IV certification for this combination therapy. This status makes the company eligible for 180 days of shared generic drug exclusivity, offering a significant competitive edge in the early phase of market entry.
Expanding US generics portfolio
With this approval, Aurobindo Pharma’s cumulative tally of USFDA approvals has reached 579 ANDAs, comprising 554 final approvals and 25 tentative approvals as of March 31, 2026. The milestone underscores the company’s sustained focus on expanding its generics portfolio in regulated markets.
Therapeutic relevance in diabetes care
Dapagliflozin and Metformin Hydrochloride extended-release tablets are prescribed as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 diabetes mellitus, particularly where dual therapy is considered appropriate.