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Morepen Labs Files First U.S. Sitagliptin ANDA Across Three Strengths
Morepen Laboratories has asked the U.S. Food and Drug Administration to approve its sitagliptin tablets.
The tablets come in three strengths: 25 mg, 50 mg, and 100 mg.
Sitagliptin is used to help treat Type 2 diabetes.
Morepen developed the tablets, tested them, and made batches under quality rules.
The company says this filing shows it can develop medicines from the active ingredient through to the final application.
It also wants to attract more contract development and manufacturing work.
Approval and commercial supply may take 24 to 36 months.
The timing will depend on the FDA’s review and applicable patent requirements.
Morepen Laboratories submitted its first U.S. ANDA for Sitagliptin Tablets USP in 25 mg, 50 mg, and 100 mg strengths.
The programme covered formulation development, scale-up, analytical validation, impurity control, stability studies, and GMP regulatory-batch manufacturing.
Managing Director Sanjay Suri said the filing combines the company’s API, finished-dose, manufacturing, and regulatory capabilities.
Morepen expects approval and commercial supply could take 24–36 months, subject to FDA review and patent requirements.
The relevant U.S. sitagliptin phosphate salt patent is scheduled to expire on 24 November 2026, with paediatric exclusivity until 24 May 2027.
- Who
- Morepen Laboratories, led in the statement by Managing Director Sanjay Suri, submitted the application to the U.S. Food and Drug Administration.
- What
- The company submitted its first Abbreviated New Drug Application for Sitagliptin Tablets USP in three strengths.
- Where
- The announcement was issued from Mumbai, and the application was submitted to the U.S. Food and Drug Administration.
- When
- The announcement was made on 28 September 2026; the relevant U.S. patent is scheduled to expire on 24 November 2026, with paediatric exclusivity through 24 May 2027.
- Why
- The filing is intended to support potential U.S. approval and commercial supply while expanding Morepen’s finished-dose development and specialised CDMO capabilities.
Key facts
- Applicant
- Morepen Laboratories Ltd
- Product
- Sitagliptin Tablets USP
- Submitted strengths
- 25 mg, 50 mg, and 100 mg
- Application
- First U.S. Abbreviated New Drug Application
- Expected timeline
- 24–36 months for approval and commercial supply, subject to FDA review and patent requirements
- Innovator product
- Januvia, with reported worldwide sales of approximately ₹13,380 crore in 2025
- Patent timing
- Sitagliptin phosphate salt patent scheduled to expire 24 November 2026; paediatric exclusivity extends to 24 May 2027
Sources
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