Adalvo has commenced pivotal bioequivalence (BE) studies for its generic Linagliptin and Metformin fixed-dose combination (FDC) tablet.
Coming soon after the company received DCP approval and marketing authorization for its Linagliptin 5mg film-coated tablet, the study is a key milestone for one of the most commercially relevant oral diabetes therapies in the global generics market.
Developed as a generic of Jentadueto, Linagliptin and Metformin FDC is indicated for the treatment of type 2 diabetes mellitus in adults. Linagliptin blocks the DPP-4 enzyme, stimulating insulin production after meals. Metformin reduces the amount of glucose released by the liver, enabling the body to use insulin more effectively. Combined in a single tablet, they deliver complementary glycaemic control without the risk of hypoglycaemia.
Type 2 diabetes represents 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 — 11.1% of the world's population — are currently living with diabetes. By 2050, that figure is projected to reach 853 million. In 2024 alone, the disease caused 3.4 million deaths and accounted for over $1 trillion in global health expenditure.
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 $878 million in 2025. With cases of type 2 diabetes set to keep rising, the commercial opportunity for licensing partners is substantial and growing.
To discuss licensing opportunities for Linagliptin and Metformin FDC, or to explore Adalvo's full diabetes portfolio, get in touch.