Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, has launched Riociguat Tablets in the United States, becoming the first companies to market a generic version of Bayer’s Adempas® (riociguat) in the country.
The generic riociguat is available in 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg strengths. The product was developed and manufactured by MSN Laboratories and has been approved by the U.S. Food and Drug Administration (USFDA) as a generic equivalent of Adempas® across all five strengths.
Riociguat is a soluble guanylate cyclase (sGC) stimulator used to treat adults with certain forms of pulmonary hypertension.
The drug is indicated for adults with:
- Persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) following surgical treatment or in patients with inoperable CTEPH, to improve exercise capacity and WHO functional class.
- Pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity and WHO functional class and delay clinical worsening.
PAH and CTEPH are rare, progressive and potentially life-threatening conditions, with patients often requiring long-term treatment.
The launch gives U.S. patients and healthcare providers access to a lower-cost generic alternative to branded riociguat. Until now, riociguat was available in the United States only as the branded product.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said the first-to-market launch represents a milestone for the company's U.S. business and highlights its capabilities in complex generics and specialty pharmaceutical products.
He also noted that availability across all five strengths is intended to provide physicians and pharmacies with flexibility when transitioning patients to the generic product.
According to Dr. MSN Reddy, Founder and CMD of MSN Laboratories, riociguat is a technically demanding molecule. He said the U.S. launch demonstrates MSN's capabilities in API and formulation research and development as well as its manufacturing capacity.
The launch could represent a significant commercial opportunity for the Zydus-MSN partnership. Riociguat sales are not separately reported by IQVIA, according to the companies.
However, Bayer reported global Adempas® sales of approximately €745 million in 2025, equivalent to approximately US$850 million, according to Bayer's 2025 Annual Report.
With Zydus bringing its established U.S. commercial platform and MSN supplying the product, the partnership is targeting a specialty market where the branded product previously had no generic competition.
The first-to-market status also positions Zydus and MSN to compete for generic riociguat prescriptions as U.S. healthcare providers and pharmacies gain access to an alternative to Adempas®.
