Zydus and MSN Collaborate to Introduce First Generic Adempas in U.S. Market

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

In a significant advancement for patients suffering from pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), Zydus Lifesciences Limited has partnered with MSN Laboratories Private Limited to launch the first generic version of Adempas® in the United States. This new offering includes Riociguat Tablets available in several strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg.

The U.S. Food and Drug Administration (FDA) has approved these tablets as a generic equivalent to the branded Adempas® product. As a soluble guanylate cyclase (sGC) stimulator, riociguat is essential in treating adults with these life-threatening conditions by improving exercise capacity and delaying clinical worsening.

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, emphasized the significance of this development, stating, "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 and our ability to execute day-one launches in specialty categories."

This launch is particularly important in light of the fact that PAH and CTEPH are rare and progressive conditions that often require lifelong treatment. Before this introduction, riociguat was only available in the U.S. as a branded medication, which could limit accessibility due to higher costs. As the first company to deliver a generic alternative, Zydus and MSN aim to provide patients and healthcare providers with more affordable treatment options.

Dr. MSN Reddy, Founder and CMD at MSN Laboratories, commented on the complex nature of riociguat as a molecule, highlighting that its successful development underlines the capabilities of MSN's research and development. With 25 manufacturing facilities across India and the USA and a unified research and development ecosystem, MSN is well-positioned to deliver a consistent and quality supply of this vital therapy.

According to Bayer's Annual Report of 2025, Adempas® achieved global sales of approximately EUR 745 million (USD 850 million), underscoring its importance in the treatment landscape for pulmonary hypertension. With the collaboration between Zydus and MSN, patients will now have better access to treatments that can significantly improve their quality of life.

Established in 2003, MSN Laboratories is a research-driven, fully integrated pharmaceutical company committed to making high-quality medicines affordable worldwide. The company has a robust presence, having filed over a thousand patents globally and is recognized for its extensive portfolio of active pharmaceutical ingredients (APIs) and finished dosage forms across various therapeutic areas.

With this new launch, Zydus Lifesciences not only enhances its product range but also contributes to the health and well-being of patients dealing with serious medical conditions. Their mission is consistent with their overarching goal to empower individuals to live healthier lives. As they continue to innovate and transform the healthcare landscape, both Zydus and MSN exemplify a commitment to providing solutions that effectively address unmet medical needs.

For more information about Zydus Lifesciences and the new Riociguat tablets, visit www.zyduslife.com and learn about the commitment to quality healthcare solutions.