Zydus Lifesciences, in partnership with MSN Laboratories, has launched generic riociguat tablets in the United States in five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg.
Developed and manufactured by MSN Laboratories, the product has received approval from the United States Food and Drug Administration (USFDA) as a generic equivalent of Adempas tablets in all five strengths.
The companies said they are the first to launch a generic version of Adempas in the US market.
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 and WHO functional class and delay clinical worsening.
“Being first to market with generic riociguat is a milestone for our US business and for patients with pulmonary hypertension,” said Dr Sharvil Patel, managing director, Zydus Lifesciences.
“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,” he added.
Dr MSN Reddy, founder and CMD, MSN Laboratories, described riociguat as a technically demanding molecule, and said bringing its first generic to the US demonstrates the depth of the company’s integrated API and formulation research and development and its manufacturing scale.
“Together with Zydus’ established US commercial platform, we are confident of delivering consistent, high-quality supply of this important therapy,” he added.
PAH and CTEPH are rare, progressive and potentially life-threatening conditions that often require long-term treatment. Until now, riociguat was available in the US only as the branded product, according to the companies.
According to Bayer’s Annual Report 2025, global sales of Adempas reached approximately EUR 745 million (around USD 850 million) in 2025.
