Lupin Launches Generic Anti-Diabetic Tablets in US, Expands Diabetes Care Portfolio

Lupin Limited has launched its generic anti-diabetic drug, Dapagliflozin and Metformin Hydrochloride extended-release tablets, in the United States, expanding its presence in one of the world’s most important pharmaceutical markets. The launch follows approval from the US Food and Drug Administration under the abbreviated new drug application, or ANDA, pathway.

The newly launched product is bioequivalent to Xigduo XR and is intended for the same indications, mainly to improve glycaemic control in adults with type 2 diabetes. Lupin has introduced the medicine in four strengths — 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg — giving physicians and patients greater treatment flexibility.

The launch strengthens Lupin’s strategy of deepening its footprint in the US generics market, especially in chronic therapy areas such as diabetes care. The extended-release combination formulation is designed to improve patient convenience by reducing dosing frequency while maintaining effective blood sugar control.

The development also reflects the broader push by Indian pharmaceutical companies to grow in regulated global markets through cost-effective generic medicines. For Lupin, which has built a diversified portfolio spanning generics, branded formulations and complex therapies, the US remains a key growth market and an important platform for future expansion.

Sources:

https://www.ibef.org/news/lupin-limited-launches-generic-anti-diabetic-tablets-in-united-states
https://www.lupin.com/media/press-releases/lupin-launches-dapagliflozin-and-metformin-hydrochloride-extended-release-tablets-in-the-united-states
https://www.lupin.com/media/press-releases/lupin-announces-approval-of-dapagliflozin-and-metformin-hydrochloride-extended-release-tablets-in-the-united-states