Lupin’s Sitagliptin Tablets secure tentative FDA approval, set to enter $5.7bn market

Global pharmaceutical giant Lupin Limited (Lupin) has announced its receipt of tentative approval from the United States Food and Drug Administration (U.S. FDA) for Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg. This approval paves the way for Lupin to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, originally produced by Merck Sharp and Dohme Corp. (Merck). The product will be manufactured at Lupin’s state-of-the-art facility in Pithampur, India.

Sitagliptin Tablets USP, in the specified dosages, are prescribed as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. This tentative approval marks a significant step for Lupin in expanding its portfolio in the lucrative diabetes medication market.

The market for Sitagliptin Tablets is substantial, with the reference listed drug (RLD) Januvia recording estimated annual sales of $5.8 billion in the U.S. (IQVIA MAT October 2023). Sitagliptin, known by the brand name Januvia among others, is a widely used anti-diabetic medication for treating type 2 diabetes. In the United Kingdom, it is considered less preferred than options like metformin or a sulfonylurea. Sitagliptin is taken orally and is also available in combination with metformin.

Lupin Gains Ground in Diabetes Treatment with Tentative Approval for Generic Januvia

Lupin’s achievement in receiving tentative FDA approval for its Sitagliptin Tablets underscores the company’s commitment to providing affordable and accessible treatment options in the healthcare sector. This approval also highlights the importance of Indian pharmaceutical companies in the global market, particularly in the area of generic drug manufacturing.

The approval not only represents a milestone for Lupin Limited in the U.S. pharmaceutical market but also signifies a significant development in the broader healthcare industry. It contributes to the availability of effective treatments for patients with type 2 diabetes, enhancing the quality of patient care and management of this widespread condition.