Zydus Lifesciences Limited, in a partnership with MSN Laboratories Private Limited, has launched the first generic version of Adempas (Riociguat tablets) in the US market, according to a regulatory filing.
The launch covers Riociguat tablets in all five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg. The product was developed and manufactured by MSN Laboratories and has received approval from the US Food and Drug Administration (USFDA) as a generic equivalent of Adempas tablets, according to the filing on Monday evening.
Riociguat is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment, or inoperable CTEPH. It is also indicated for adults with pulmonary arterial hypertension (PAH) to improve exercise capacity, functional class and delay clinical worsening.
Sharvil Patel, managing director of Zydus Lifesciences, said being the “first to market with generic Riociguat represents a milestone for the company’s US business and reflects the strength of its complex-generics pipeline and execution capabilities”.
MSN Reddy, founder and CMD of MSN Laboratories, noted that bringing the first generic of the technically-demanding molecule to the US demonstrates the depth of MSN’s integrated API and formulation R&D, alongside its manufacturing scale.
According to the Bayer’s Annual Report 2025 cited in the filing, global sales of Adempas were approximately USD 850 million in 2025.
Published on October 6, 2026
