Lupin Limited (Lupin) has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp and Dohme Corp. (Merck). This product will be manufactured at Lupin's Pithampur facility in India.

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Sitagliptin Tablets (RLD Januvia) had estimated annual sales of USD 5789.3 million in the U.S. (IQVIA MAT October 2023).