Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, has launched the first generic version of Adempas® (riociguat) tablets in the United States. The product has received approval from the US Food and Drug Administration (USFDA) and is available in five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg.
Developed and manufactured by MSN Laboratories, the tablets are approved as a generic equivalent of Adempas® across all five strengths. The launch expands the availability of riociguat, a prescription medicine used to treat certain forms of pulmonary hypertension.
Riociguat belongs to a class of medicines known as soluble guanylate cyclase (sGC) stimulators. It is indicated for adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH), classified as WHO Group 4, following surgical treatment or in cases where surgery is not possible. The medicine is used to improve exercise capacity and World Health Organization (WHO) functional class.
It is also indicated for adults with pulmonary arterial hypertension (PAH), classified as WHO Group 1, to improve exercise capacity and functional class and delay clinical worsening. CTEPH and PAH are serious conditions that affect the blood vessels in the lungs and can limit patients’ ability to carry out physical activities. Treatment is aimed at managing symptoms, improving functional capacity and slowing disease progression.
Dr Sharvil Patel, Managing Director of Zydus Lifesciences Limited, said, “Being first to market with generic riociguat is a milestone for our USbusiness and for patients with pulmonary hypertension. It reflects the strength of our complex-generics pipeline, our ability to execute day-one launches in specialty categories, and the strength of our partnerships that complement our commercial reach in the United States. We are pleased to enable access to the drug across all five strengths, allowing physicians and pharmacies to transition patients with confidence.”
Dr MSN Reddy, Founder and Chairman and Managing Director of MSN Laboratories, said, “Riociguat is a technically demanding molecule, and bringing the first generic to the US demonstrates the depth of MSN’s integrated API and formulation R&D and the scale of our manufacturing. Together with Zydus’ established US commercial platform, we are confident of delivering consistent, high-quality supply of this important therapy.”
The launch combines MSN Laboratories’ research, formulation development and manufacturing capabilities with Zydus’ established commercial presence in the US pharmaceutical market. The companies aim to supply the medicine across all five approved strengths.
Zydus Lifesciences is a global life sciences company engaged in discovering, developing, manufacturing and marketing healthcare products. The group employs more than 30,000 people worldwide, including approximately 1,500 scientists working in research and development.
MSN Laboratories is an Indian pharmaceutical company with capabilities in active pharmaceutical ingredients (APIs), formulation development and manufacturing. Its work includes the development of complex pharmaceutical products for domestic and international markets.
