Product Launch Details
Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, announced the launch of Riociguat Tablets in the United States market. The launch includes all five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg. This represents the first generic version of Adempas® (riociguat) to enter the U.S. market.
Regulatory Approval and Indications
The Riociguat Tablets are approved by the United States Food and Drug Administration (USFDA) as a generic equivalent of Adempas® Tablets. The product is indicated for:
- 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
- Treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to delay clinical worsening
Riociguat is a soluble guanylate cyclase (sGC) stimulator.
Partnership Structure and Roles
- MSN Laboratories developed and manufactures the Riociguat Tablets
- Zydus Lifesciences leads the commercial distribution in the United States
- The partnership combines MSN's manufacturing and R&D capabilities with Zydus' established U.S. commercial platform
Market Context and Financial Significance
PAH and CTEPH are rare, progressive and life-threatening conditions where patients typically remain on therapy for life. Previously, riociguat was available in the United States only as the branded product Adempas®.
According to Bayer's Annual Report 2025, the global sales of Adempas® were approximately EUR 745 million (approximately USD 850 million) in 2025. Sales of riociguat are not reported by IQVIA.
Management Commentary
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited stated: "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 stated: "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."
Strategic Significance
The launch represents:
- First-to-market generic advantage in the United States
- Demonstration of complex-generics pipeline strength for Zydus
- Execution capability for day-one launches in specialty categories
- Partnership model that complements commercial reach
- Technical manufacturing capability demonstration for MSN
Company Background
Zydus Lifesciences Ltd. employs over 30,000 people worldwide, including 1,500 scientists engaged in R&D. The group has introduced several innovative, first-in class products over the last decade.
MSN Laboratories Group operates 25 manufacturing facilities across India and the USA, with over 1,000 patents filed globally, 200+ ANDA submissions, and a leading position in US DMF filings. The company has a portfolio of 550+ APIs and 400+ finished dosage forms across 35+ therapeutic areas, serving over 50 million patients in more than 100 countries.
Trademark Information
Adempas® is a registered trademark of Bayer. All other trademarks are the property of their respective owners.