First-to-market generic of Adempas (Riociguat Tablets) launched in the U.S

Zydus and MSN launch Riociguat Tablets in the U.S. — the first generic of Adempas®.

Mon 5 Oct 2026

Strengths launched in the U.S.

0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg

Regulatory approval

USFDA-approved as a generic equivalent of Adempas® Tablets

First-to-market status

the first generic of Adempas®

Adempas® global sales

about EUR 745 million (approx. USD 850 million) in 2025

First-to-market U.S. launch

Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, has announced the launch of Riociguat Tablets in the United States. Riociguat is the generic version of Adempas®. The companies state they are the first to launch a generic version of Adempas® in the U.S. market. The product is developed and manufactured by MSN.

What is being launched

• Riociguat Tablets in five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg
• 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

What the medicine is used for

• 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
• Adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to delay clinical worsening

The announcement describes PAH and CTEPH as rare, progressive and life-threatening conditions in which patients typically remain on therapy for life.

Market reference point

The release states that until now riociguat was available in the United States only as the branded product, and that sales of riociguat are not reported by IQVIA. Citing Bayer's Annual Report 2025, it notes global sales of Adempas® of approximately EUR 745 million (approximately USD 850 million) in 2025. Adempas® is a registered trademark of Bayer.

In the companies' words

• Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, called being first to market with generic riociguat a milestone for the company's U.S. business and for patients, referred to the strength of its complex-generics pipeline and its ability to execute day-one launches in specialty categories, and said access across all five strengths allows physicians and pharmacies to transition patients with confidence.
• Dr. MSN Reddy, Founder & CMD, MSN Laboratories, said riociguat is a technically demanding molecule and that bringing the first generic to the U.S. demonstrates the depth of MSN's integrated API and formulation R&D and the scale of its manufacturing.

The two partners

• Zydus: an innovative global life sciences company that discovers, develops, manufactures and markets healthcare therapies; employs over 30,000 people worldwide, including 1,500 scientists engaged in R&D.
• MSN Laboratories: a research-driven, fully integrated pharmaceutical company established in 2003; operates 25 manufacturing facilities across India and the USA; over 1,000 patents shared globally; 200+ ANDA submissions; a portfolio of 550+ APIs and 400+ finished dosage forms across 35+ therapeutic areas; serves over 50 million patients in more than 100 countries.

How to read this announcement

This is a press release shared with the stock exchanges about a product launch in the U.S. market. It sets out what is being launched, the approval cited, the conditions the medicine is used for and the comments of the two partners.

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