Lupin Limited has announced the U.S. launch of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. This medication, approved by the U.S. FDA, is bioequivalent to Xigduo® XR. Available in multiple strengths including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg, the product launch expands Lupin’s portfolio in the anti-diabetic therapeutic space.
Expansion of Diabetes Care Portfolio
On April 22, 2026, Lupin Limited officially announced the launch of its latest generic pharmaceutical product in the United States: Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. This launch represents a strategic step for the company in strengthening its presence in the highly competitive U.S. anti-diabetic market.
Product Specifications and Regulatory Status
The product has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). The tablets are recognized as a bioequivalent to Xigduo® XR, a reference drug developed by AstraZeneca AB. The generic medication is now available in four distinct dosage strengths to cater to specific patient needs:
- 5 mg / 500 mg
- 5 mg / 1,000 mg
- 10 mg / 500 mg
- 10 mg / 1,000 mg
Impact on Global Operations
This addition to the U.S. market reinforces Lupin’s capabilities as a global pharmaceutical leader. With a robust research and development infrastructure, the company continues to focus on complex formulations. This launch is expected to enhance patient access to cost-effective treatment options for managing diabetes, further solidifying Lupin’s reputation in the cardiovascular and anti-diabetic therapeutic areas.
Source: BSE
