Zydus launches first generic Riociguat tablets in US
- Zydus Lifesciences and MSN Laboratories launched the first generic of Adempas (Riociguat) in the US
- The product is approved by USFDA in all five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg
- Global sales of branded Adempas were approximately USD 850 million in 2025 according to Bayer
*this image is generated using AI for illustrative purposes only.
Zydus Lifesciences , in partnership with MSN Laboratories, launched the first generic version of Adempas (Riociguat Tablets) in the United States on October 5, 2026.
Launch details and market impact
The jointly launched product marks the first generic entry for Riociguat Tablets in the US market. The collaboration brings this generic version to American patients living with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Zydus and MSN are the first companies to launch a generic version of Adempas in the US.
| Parameter | Details |
|---|---|
| Product | Riociguat Tablets (generic Adempas) |
| Market | United States |
| Partners | Zydus Lifesciences and MSN Laboratories |
| Generic status | First generic version |
| Strengths | 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg |
| Developer/Manufacturer | MSN Laboratories |
The launch represents a significant milestone for both companies. Being first to market with a generic equivalent typically provides a competitive advantage in the US pharmaceutical space. The product was developed and is manufactured by MSN, leveraging their integrated API and formulation R&D capabilities.
Clinical indications and regulatory approval
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 adults with persistent or recurrent CTEPH (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class. It is also indicated for adults with PAH (WHO Group 1) to improve exercise capacity, improve WHO functional class, and delay clinical worsening.
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, stated that being first to market reflects the strength of their complex-generics pipeline and ability to execute day-one launches in specialty categories. Dr. MSN Reddy, Founder & CMD, MSN Laboratories, highlighted that riociguat is a technically demanding molecule, demonstrating the depth of MSN's manufacturing scale.
Market context
PAH and CTEPH are rare, progressive, and life-threatening conditions where patients typically remain on therapy for life. Until this launch, riociguat was available in the United States only as the branded product. According to Bayer's Annual Report 2025, global sales of Adempas were approximately EUR 745 million (approximately USD 850 million) in 2025. Sales of riociguat are not reported by IQVIA.
How will the first-mover advantage impact Zydus and MSN's market share capture rate against Bayer's branded Adempas in the initial 12 months?
What pricing strategy are Zydus and MSN adopting for the generic Riociguat, and how does it compare to the branded product's current reimbursement rates?
Are there pending Paragraph IV certifications or litigation risks from Bayer that could threaten the exclusivity period of this first generic launch?
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