India Pharma Outlook Team | Tuesday, 06 October 2026
Zydus advances its specialty ambitions with the first generic launch of Adempas in the United States.
This move delivers a lower-cost alternative for patients with rare pulmonary hypertension.
Zydus Lifesciences partners with MSN Laboratories to bring riociguat tablets to market across all five approved strengths.
MSN handles development and manufacturing while Zydus leads commercialization and marketing. Until now, only Bayer’s branded Adempas reached U.S. patients.
The first-to-market generic opens a sizeable opportunity in a therapy that patients typically take for life and signals Zydus’s growing focus on complex, higher-value products.
Zydus Managing Director Sharvil Patel calls the launch a milestone for the company’s U.S. business. He highlights the strength of its complex-generics pipeline, its ability to execute day-one launches in specialty categories, and the partnerships that complement its commercial reach.
Patel notes that offering all five strengths allows physicians and pharmacies to transition patients with confidence. MSN Founder and CMD Dr M.S.N. Reddy describes riociguat as a technically demanding molecule.
Bringing the first generic to the U.S. demonstrates the depth of MSN’s integrated API and formulation R&D plus its manufacturing scale. He expresses confidence that the combination with Zydus’s established commercial platform will deliver consistent, high-quality supply.
The move fits Zydus’s pattern of pursuing high-barrier products that can support a shift toward higher-margin specialty offerings. Following the announcement, Zydus shares rose more than 1.5 percent on the NSE.
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Riociguat is a soluble guanylate cyclase stimulator. Doctors prescribe it for adults with persistent or recurrent chronic thromboembolic pulmonary hypertension after surgery, or when surgery is not an option, to improve exercise capacity and WHO functional class.
They also use it for pulmonary arterial hypertension to improve exercise capacity, functional class, and delay clinical worsening. These rare, progressive conditions often require lifelong treatment. The arrival of a generic option across every strength gives patients and clinicians a lower-cost pathway that was previously unavailable.
Key details of the launch:
Bayer reported global Adempas sales of roughly €745 million, or about USD 850 million, in 2025. The drug lost patent protection in the U.S. this year after earlier losses in markets such as China, Canada, and Brazil. Sandoz already markets a generic in Canada and awaits U.S. approval, making the Zydus-MSN first-mover position strategically important.
Through securing the initial generic entry, Zydus and MSN position themselves to capture share in a specialty segment where patients stay on therapy for years. The launch reinforces Zydus’s push into complex generics and specialty products that can offset pressure in more commoditized categories while expanding affordable access for people living with pulmonary hypertension.
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