Zydus, MSN Launch First Generic of Adempas (Riociguat) in US Across 5 Strengths
New Delhi: Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, has launched the first generic version of Adempas (riociguat) in the United States across five strengths, offering a lower-cost treatment option for patients with pulmonary hypertension.
The companies announced the launch of Riociguat Tablets in strengths of 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg. The product was developed and is manufactured by MSN Laboratories.
Riociguat Tablets have received US Food and Drug Administration (USFDA) approval 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) following surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class.
It is also indicated for adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and delay clinical worsening.
Commenting on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences Limited, 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. Until now, 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, global sales of Adempas® were approximately EUR 745 million, or around USD 850 million, in 2025.
Adempas is a registered trademark of Bayer.
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