Zydus, MSN partner to Launch First Generic of Adempas® (Riociguat Tablets) in the U.S.

First-to-market launch brings a lower-cost riociguat to U.S. patients living with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

AHMEDABAD, India and PENNINGTON, N.J., Oct. 5, 2026 /PRNewswire/ -- Zydus Lifesciences Limited (Zydus), in partnership with MSN Laboratories Private Limited (MSN), today announced the launch of Riociguat Tablets, 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg, in the United States. Zydus and MSN are the first companies to launch a generic version of Adempas^® (riociguat) in the U.S. market. The product was developed and is manufactured by MSN.

Riociguat Tablets are approved by the United States Food and Drug Administration (USFDA) 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) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class; and for adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to 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. So far, 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, the global sales of Adempas^® were approximately EUR 745 million (approximately USD 850 million) in 2025 (source: https://www.bayer.com/sites/default/files/2026-03/bayer-annual-report-2025.pdf).

About Zydus

Zydus Lifesciences Ltd., with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 30,000 people worldwide, including 1,500 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries. Over the last decade, Zydus has introduced several innovative, first-in class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals, and New Chemical Entities. For more details visit www.zyduslife.com

About MSN Laboratories

MSN Laboratories Group is a research-driven, fully integrated pharmaceutical company established in 2003, with a mission to make high-quality medicines accessible and affordable worldwide. The group operates 25 manufacturing facilities across India and the USA, supported by a unified R&D ecosystem spanning both API and finished dosage development. With over 1,000 patents filed globally, 200+ ANDA submissions and a leading position in US DMF filings, MSN has built a strong global presence. With a portfolio of 550+ APIs and 400+ finished dosage forms across 35+ therapeutic areas, MSN serves over 50 million patients in more than 100 countries. For more details visit www.msnlabs.com. 

Adempas^® is a registered trademark of Bayer. All other trademarks are the property of their respective owners.

SOURCE Zydus Lifesciences