Extending the company's dossier list in one of the most commercially relevant oral diabetes therapies in the global generics market.
Zug, Switzerland, 10 August 2026: Adalvo today announced the submission of its Decentralised Procedure (DCP) for its generic Linagliptin and Metformin fixed-dose combination (FDC) tablets. The filing builds on the recent DCP approval and marketing authorisation of Adalvo's Linagliptin 5mg film-coated tablet extending the company's dossier list in one of the most commercially relevant oral diabetes therapies in the global generics market. With one of the few generic's portfolios spanning both oral and injectable diabetes treatments, Adalvo is establishing itself as a leader in this space.
Developed as a generic of Jentadueto®, the Linagliptin and Metformin fixed-dose combination is indicated for the treatment of type 2 diabetes mellitus in adults.
Type 2 diabetes is one of the most urgent and fast-growing challenges in global healthcare. A 2025 report from the International Diabetes Federation estimates that 589 million adults of adults aged 20-79, 11.1% are living with diabetes, a figure projected to reach 853 million by 20501.
Low- and middle-income countries carry 80% of the diabetes burden, and over half of those affected in these regions remain undiagnosed. As diagnostic coverage improves, patient numbers will rise sharply, driving significant demand for affordable oral therapies.
According to IQVIA, the total addressable market for Linagliptin and Metformin was USD 393M as of 2025, and with type 2 diabetes cases set to keep rising, the commercial opportunity for licensing partners is substantial and growing. The submission reflects Adalvo's long-term investment in complex generics and its clearly defined intellectual property strategy.
"Filing this fixed-dose combination shows exactly how we work: disciplined regulatory execution matched to real patient need. Type 2 diabetes is one of the defining health challenges of our time, and affordable, high-quality oral therapies will be central to meeting it. I am proud of the team, and proud that Adalvo continues to give partners early access to the medicines patients' needs most."
This submission reflects Adalvo's commitment to advancing high-quality, differentiated generic medicines and expanding future treatment options for patients through rigorous development and regulatory execution.
Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force.
Jentadueto® is a registered trademark of Boehringer Ingelheim International GmbH.
- Magliano DJ, Boyko EJ; Diabetes Atlas 11th edition scientific committee. Brussels: International Diabetes Federation; 2025.