Mumbai: Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, announced on October 5, 2026, the launch of Riociguat Tablets in the United States. The tablets are available in 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg strengths.
Market Launch
Zydus and MSN are the first companies to introduce a generic version of Adempas® (riociguat) in the US market. The product was developed and is manufactured by MSN.
Regulatory Approval
Riociguat Tablets have received approval from the United States Food and Drug Administration (USFDA) as a generic equivalent of Adempas® Tablets across all five strengths. The medication is indicated for treating adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH).
Management Commentary
Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said being first to market with generic riociguat is a milestone for their US business and for patients with pulmonary hypertension. He stated it reflects the strength of their complex-generics pipeline and their ability to execute day-one launches in specialty categories.
Partner's Contribution
MSN Reddy, Founder and CMD, MSN Laboratories, said Riociguat is a technically demanding molecule. He added that bringing the first generic to the US demonstrates the depth of MSN's integrated API and formulation R&D and the scale of their manufacturing.
Market Impact
The launch aims to provide a lower-cost riociguat to US patients living with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Bayer's Annual Report 2025 indicated global sales of Adempas® were approximately EUR 745 million (about USD 850 million) in 2025.
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