Lupin receives FDA approval for Sitagliptin and Metformin tablets, a generic Janumet®, enhancing diabetes care options

Lupin Limited, a global pharmaceutical leader, announced receiving tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application  (ANDA) for Sitagliptin and Metformin Hydrochloride Tablets in dosages of 50 mg/500 mg and 50 mg/1000 mg. This approval allows Lupin to produce a generic version of Janumet® Tablets, initially developed by Merck Sharp & Dohme LLC, at its manufacturing facility in Pithampur, India.

The combination drug, Sitagliptin and Metformin Hydrochloride Tablets is prescribed as a supplement to diet and exercise to enhance glycaemic control in adults with type 2 diabetes. This development expands treatment accessibility for diabetic patients by offering a cost-effective alternative to branded medication.

Janumet® Tablets, in these specific dosages, have generated annual sales of approximately $1.145 billion in the U.S., according to IQVIA data as of September 2024. With this tentative approval, Lupin is assured of entering a significant market segment upon final approval. This milestone emphasises Lupin’s commitment to providing affordable and high-quality healthcare solutions while supporting its presence in the U.S. pharmaceutical market.