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Adalvo prepares multiple filings for generic linagliptin/metformin FDC tablet

Business
24 June 2026

Adalvo is preparing filings for its generic linagliptin/metformin fixed-dose combination (FDC) tablet across multiple regions, including Europe via the DCP. The move advances the programme towards global market entry. 

It also reinforces Adalvo’s focus on expanding access to established, effective therapies for type 2 diabetes, particularly in markets where affordability and supply constraints remain a significant barrier to treatment

Globally, 589 million people are living with type 2 diabetes, with the majority based in low- and middle-income countries. With patient numbers forecast to reach 853 million by 2050, the need for affordable, accessible treatments is expected to grow in parallel. 

The cost of GLP-1 therapies can restrict patient access, particularly in regions with limited cold-chain infrastructure. 

This reinforces the role of oral, fixed-dose combination therapies such as linagliptin/metformin. As a solid formulation, it avoids the need for cold-chain logistics, enabling a more reliable supply

Combining two complementary treatments into a single tablet also supports patient adherence — a persistent challenge in long-term diabetes management. 

These characteristics support broader adoption across diverse healthcare settings, particularly where simplicity, affordability and supply reliability are critical. 

Adalvo remains committed to building a diverse and differentiated portfolio that is aligned with evolving global healthcare needs, and which improves access to essential therapies. 

To discuss licensing opportunities for linagliptin/metformin FDC, or to see Adalvo's full diabetes portfolio, email enquiries@adalvo.com