Lupin, Zydus Secure USFDA Nod for Dapagliflozin Tablets
New Delhi: Lupin Limited and Zydus Lifesciences Limited have received approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg, strengthening their presence in the anti-diabetic segment in the US market.
Lupin announced that it has received approval for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, which are bioequivalent to the reference listed drug Farxiga of AstraZeneca. The approval enables the company to market the product in the United States for the approved indications.
On the other hand, Zydus Lifesciences has received final USFDA approval for the same strengths of Dapagliflozin Tablets. With this approval, Zydus becomes eligible for 180 days of shared generic drug exclusivity, providing a competitive advantage in the US generics market.
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Highlighting the market opportunity, Zydus noted that Dapagliflozin tablets recorded annual sales of approximately USD 10.2 billion in the United States for the twelve months ending February 2026, underscoring the strong demand for the drug. The company also stated that the product will be manufactured at its formulation facility located in the Special Economic Zone (SEZ) in Ahmedabad.
In terms of regulatory progress, Zydus has received a total of 436 approvals and has filed 505 ANDAs since the start of its filing process in FY 2003-04, reflecting its growing footprint in the global generics space.
Lupin, headquartered in Mumbai, is a global pharmaceutical company with operations in over 100 markets and a diverse portfolio spanning generics, complex generics, biotechnology products, and active pharmaceutical ingredients across key therapeutic areas including cardiovascular and anti-diabetic segments.
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