Zydus, MSN launch generic riociguat in US
Riociguat Tablets are approved by the USFDA as a generic equivalent of Adempas Tablets in five strengths
Zydus Lifesciences (Zydus), in partnership with MSN Laboratories (MSN), has announced the launch of Riociguat Tablets, 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg, in the United States. Zydus and MSN are the first companies to launch a generic version of Adempas (riociguat) in the US market. The product was developed and is manufactured by MSN.
Riociguat Tablets are approved by the United States Food and Drug Administration (USFDA) as a generic equivalent of Adempas Tablets in all five strengths. Riociguat is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class; and for adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to delay clinical worsening.
Commenting on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences, said, “Being first to market with generic riociguat is a milestone for our U.S. business 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 & CMD, MSN Laboratories, said, “Riociguat is a technically demanding molecule, and bringing the first generic to the U.S. demonstrates the depth of MSN’s integrated API and formulation R&D and the scale of our manufacturing. 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. So far, riociguat was available in the United States only as the branded product.
Sales of riociguat are not reported by IQVIA. According to Bayer’s Annual Report 2025, the global sales of Adempas were approximately EUR 745 million (approximately USD 850 million) in 2025.