Lupin Receives Tentative FDA Approval for Generic Janumet
Key Insights
Lupin has been granted tentative FDA approval for its generic version of Janumet (sitagliptin and metformin hydrochloride) tablets, used to manage type 2 diabetes.
The generic drug will be available in 50 mg/500 mg and 50 mg/1000 mg strengths, mirroring the original Janumet formulation.
Sitagliptin and metformin hydrochloride tablets are indicated to improve glycemic control in adult patients with type 2 diabetes mellitus (search) when used alongside diet and exercise.
Lupin has secured tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for sitagliptin and metformin hydrochloride tablets, offering a generic alternative to Merck Sharp & Dohme’s Janumet. The approved strengths include 50 mg/500 mg and 50 mg/1000 mg tablets.
The generic medication is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients diagnosed with type 2 diabetes mellitus (search). This condition affects millions of adults in the United States, contributing significantly to healthcare costs and reduced quality of life.
Lupin's sitagliptin and metformin hydrochloride tablets will be manufactured at the company’s Pithampur facility in India. According to IQVIA data from September 2024, the market for Janumet tablets had an estimated annual sales value of $1.145 billion.
This tentative approval allows Lupin to market its generic version of Janumet once all legal and regulatory requirements are met, potentially offering a more affordable treatment option for patients with type 2 diabetes. The availability of generic medications is crucial in reducing healthcare costs and increasing patient access to essential treatments.