Morepen Laboratories500288New product launch

First U.S. ANDA submitted to USFDA for Sitagliptin Tablets in three strengths

Morepen has submitted its first-ever Abbreviated New Drug Application (ANDA) to the U.S. FDA — for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths.

By ScoutQuest · Mon 28 Sep 2026, 8:54 AM IST · 2 min read

ANDA Number: ANDA No. 221758
Submission Date: 25th September 2026
Drug Name and Strengths: Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths
Estimated Timeline to Approval: 24–36 months from submission to progress towards approval and commercial supply
Innovator Product 2025 Sales: Januvia recorded worldwide sales of about US$1.604 billion in 2025

What was announced

Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths. The application, ANDA No. 221758, was submitted on 25th September 2026.

What an ANDA is

An ANDA is the application a company files to sell a generic version of an already-approved drug in the United States. Update it is a step, not an approval: the company itself notes that submission does not constitute FDA acceptance for substantive review, product approval, or authorization for U.S. commercial supply.

Why the company calls it a capability milestone

Morepen is known mainly for active pharmaceutical ingredients (APIs). This programme brought together formulation development and scale-up, analytical method development and validation, impurity control, stability studies, manufacture of regulatory batches under GMP systems, bioequivalence strategy, coordination with contract research organizations, and integration of study data into the dossier.

The company says these capabilities strengthen its ability to take on specialized CDMO (contract development and manufacturing) assignments spanning API development, finished dosage formulation and regulatory submission.

Timeline indicated

Morepen estimates 24–36 months from submission to progress towards approval and commercial supply.
This is subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements, and applicable patent and exclusivity requirements.

About the molecule and market context

Sitagliptin is an oral treatment for adults with Type 2 diabetes, in the DPP-4 inhibitor class (gliptins). The innovator product, Januvia, recorded worldwide sales of approximately US$1.604 billion in 2025 per Merck's 2025 Annual Report. The company clarifies this is historical innovator sales, not the size of the generic market nor a forecast of Morepen's revenue.

On patents: the relevant U.S. sitagliptin phosphate salt patent is scheduled to expire on 24th November 2026, with associated paediatric exclusivity extending to 24th May 2027. Settlement arrangements permit certain manufacturers to enter earlier.

Management commentary

Managing Director Mr. Sanjay Suri said capability building is central to Morepen's next phase of growth, and that the first ANDA brings together the scientific, manufacturing and regulatory skills needed to take an API through finished dosage development to a U.S. Update. He linked it to the planned Innovation Hub and investments in advanced chemistry and technology.

Stated forward plans

Customer development programs, technology transfer, co-development and licensing opportunities.
Product and dossier development for regulated markets in Europe and Asia, tailored to each jurisdiction.
Over time, exploring differentiated formulations including potential U.S. 505(b)(2) programs, subject to product-specific studies and regulatory requirements.

How investors may read this

The announcement is a capability and pipeline development rather than a revenue event. There is no order value, contract or earnings figure attached. Any commercial outcome depends on FDA review, facility inspection and patent/exclusivity conditions, and on the competitive intensity in the U.S. generic sitagliptin market. The company itself flags that these are forward-looking statements subject to regulatory outcomes, development results and market conditions.

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