Zydus Lifesciences Ltd in partnership with MSN Laboratories Private Ltd have partnered to launch Riociguat tablets in the USA.
Riociguat, developed and manufactured by MSN, is approved by the FDA as a generic equivalent of Adempas, a medicine used to treat pulmonary hypertension. The launch applies to 0.5mg, 1mg, 1.5mg, 2mg and 2.5mg.
“Being first to market with generic Riociguat is a milestone for our US business and for patients with pulmonary hypertension,” said Zydus managing director Dr Sharvil Patel. “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 US.”
Riociguat is a soluble guanylate cyclase (sGC) stimulator used to treat adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment, or inoperable CTEPH; and for adults with pulmonary arterial hypertension.
“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,” said MSN founder Dr MSN Reddy. “Together with Zydus’ established U.S. commercial platform, we are confident of delivering consistent, high-quality supply of this important therapy.”
PAH and CTEPH are rare, progressive and life-threatening conditions in which patients typically remain on therapy for life. Until now, Riociguat was only available in the US as the branded product.
