Lupin and Zydus Lifesciences have entered into a licensing and supply agreement to co-market, Saroglitazar Mg for the treatment of NonAlcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steato Hepatitis (NASH) in India.
Under the terms of this agreement, Lupin will have semi-exclusive rights to co-market the product in India under the brand name LINVAS. Zydus launched the drug under the brand names Lipaglyn and Bilypsa and will continue to market them. Lupin will pay Zydus upfront licensing fees and milestone payments based on the achievement of pre-defined milestones.
Saroglitazar Mg was launched in India in September 2013 for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. It reduces co-morbidities (dyslipidemia, hypertriglyceridemia, and diabetes mellitus). In January 2020, Saroglitazar Mg was approved for treating Type 2 Diabetes Mellitus. In March 2020, Saroglitazar Mg received approval for the treatment of NASH. Later that year, the drug was also approved for the treatment of NAFLD.