Morepen files first US drug application, eyes generic diabetes market

On September 25, 2026, Morepen Laboratories Ltd filed its initial Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration, seeking approval for Sitagliptin Tablets USP in three different strengths. The submission is the Indian pharmaceutical firm's first attempt at a full regulatory filing for the US market.

Sitagliptin is a medication used to treat Type 2 diabetes, falling under the DPP-4 inhibitor drug class. Its brand name, Januvia, is manufactured by Merck and generated global sales of around $1.604 billion in 2025. The patent on a relevant phosphate salt formulation will expire in November 2026, while paediatric exclusivity will continue until May 2027; however, certain other manufacturers have earlier-entry agreements in place.

Morepen anticipates a 24 to 36-month window from the time of submission to potential approval and subsequent market availability, contingent upon FDA review, facility inspections, and patent clearance. The specific ANDA reference number assigned to this application is 221758. The company is clear that the filing does not imply FDA acceptance or product approval.

The Sitagliptin development program encompassed various stages, including formulation development, analytical method validation, impurity control, stability studies, bioequivalence strategy establishment, and coordination with external research organizations. These activities, according to Morepen's Managing Director Sanjay Suri, represent a significant milestone in building the company's capabilities in contract development and manufacturing organization (CDMO) services.

As of Monday, Morepen's shares traded at ₹122.00 on the National Stock Exchange, representing a 1.35 percent increase, and the company's market capitalization stands at approximately ₹6,683 crore. The stock has increased by nearly 196 percent year-to-date and trades at a trailing price-to-earnings ratio of 46.94.