Morepen Laboratories Files First U.S. ANDA for Generic Sitagliptin Tablets
核心洞察
Morepen Laboratories (搜索) submitted ANDA No. 221758 to the U.S. FDA on September 25, 2026, for sitagliptin tablets USP in 25 mg, 50 mg and 100 mg strengths.
The filing is the Indian company's first U.S. finished-dose submission and extends its API and CDMO work into formulation development, bioequivalence and regulatory dossier preparation.
The relevant U.S. sitagliptin phosphate salt patent expires in November 2026, with paediatric exclusivity running to May 2027, and Morepen estimates 24 to 36 months to approval and commercial supply.
Morepen Laboratories (搜索) 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 company said on September 28, 2026. The application, ANDA No. 221758, was filed on September 25, 2026.
Sitagliptin is an established oral treatment for adults with type 2 diabetes (搜索) and belongs to the DPP-4 (搜索) inhibitor class, commonly known as gliptins. The innovator product, Januvia, recorded worldwide sales of approximately USD 1.604 billion in 2025, according to Merck (搜索)'s 2025 annual report. Morepen noted that this figure represents historical innovator sales rather than the total generic market or a forecast of its own potential revenue.
From API supplier to finished-dose filer
The submission extends Morepen's established active pharmaceutical ingredient and contract development and manufacturing organisation capabilities into integrated finished dosage development and regulatory filing. The sitagliptin programme covers formulation development and scale-up, analytical method development and validation, impurity control, stability studies and manufacture of regulatory batches under GMP systems. It also incorporates bioequivalence strategy, coordination with contract research organisations and integration of development and study data into the regulatory dossier.
"Capability building is central to Morepen's next phase of growth. Our first ANDA submission brings together the scientific, manufacturing and regulatory skills needed to take an API through finished dosage development to a U.S. filing," said Sanjay Suri, managing director of Morepen Laboratories (搜索).
Suri added that the milestone, alongside a planned Innovation Hub and investments in advanced chemistry and technology, strengthens the company's ability to undertake specialised CDMO assignments and build long-term development partnerships.
Morepen said the programme broadens the scope and complexity of customer programmes it can undertake, spanning API development, finished dosage formulation and regulatory submission. The company intends to build on the foundation through customer development programmes, technology transfer, co-development and licensing opportunities, and said the capabilities can also support product and dossier development for regulated markets across Europe and Asia, tailored to each jurisdiction's requirements. Over time, Morepen aims to explore differentiated formulations, including potential U.S. 505(b)(2) development programmes, subject to product-specific studies and regulatory requirements.
Patent timing and approval expectations
The relevant U.S. sitagliptin phosphate salt patent is scheduled to expire on November 24, 2026, with associated paediatric exclusivity extending to May 24, 2027. Morepen said settlement arrangements permit certain manufacturers to enter earlier.
Morepen currently estimates 24 to 36 months from submission to progress towards approval and commercial supply, subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements, and applicable patent and exclusivity requirements.
The company stated that the submission does not constitute FDA acceptance for substantive review, product approval or authorisation for U.S. commercial supply. References to Europe, Asia and potential 505(b)(2) programmes describe future development opportunities, each of which would require its own supporting data and applicable regulatory submissions and approvals.
Morepen Laboratories (搜索) is an Indian pharmaceutical company with established expertise in active pharmaceutical ingredients and a growing focus on contract development and manufacturing. The company said it is expanding its scientific, manufacturing and regulatory capabilities to support integrated development programmes and long-term partnerships with global pharmaceutical customers.