Ahmedabad, India and Pennington, New Jersey, U.S., October 5, 2026
Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, has announced the U.S. launch of generic riociguat tablets, becoming the first companies to introduce a generic version of Adempas® (riociguat) in the American market. The product is available in five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg, providing an alternative to the branded therapy for eligible patients with pulmonary hypertension. Developed and manufactured by MSN Laboratories, the product has received approval from the U.S. Food and Drug Administration (FDA) as a generic equivalent of Adempas across all five strengths.
First Generic Riociguat Reaches U.S. Market
Riociguat is a soluble guanylate cyclase (sGC) stimulator used to treat adults with specific forms of pulmonary hypertension. The FDA-approved generic is indicated for adults with persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following surgical treatment, as well as patients with inoperable CTEPH. It is also indicated for adults with pulmonary arterial hypertension (PAH). Treatment with riociguat can improve exercise capacity and WHO functional class and delay clinical worsening in appropriate patients. With the first generic launch, Zydus and MSN are expanding pharmaceutical options in a specialty therapeutic area where riociguat had previously been available in the United States only as the branded product. The availability of all five approved strengths is intended to support prescribing and dispensing across the required dosage range.
Zydus and MSN Expand Complex Generic Portfolio
The launch highlights the companies’ capabilities in complex generic drug development, formulation, manufacturing, and U.S. commercialization. MSN Laboratories developed and manufactures the riociguat product, while Zydus brings its established U.S. commercial platform to the partnership. According to the companies, riociguat is a technically demanding molecule, requiring integrated expertise in active pharmaceutical ingredient development and finished-dose formulation. The partners say the first-to-market launch reflects their ability to develop and manufacture specialty pharmaceutical products and bring them to patients following regulatory approval. For Zydus, the launch represents another milestone in its U.S. business and its strategy of expanding access to complex and specialty generic medicines. MSN’s integrated API and formulation R&D capabilities provide the manufacturing and development foundation for the product.
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Generic Option Targets Rare Pulmonary Hypertension
Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension are rare, progressive, and potentially life-threatening diseases that often require long-term treatment. PAH is classified as WHO Group 1 pulmonary hypertension, while CTEPH is categorized as WHO Group 4. Patients with these conditions may require continuous therapy to manage symptoms, maintain functional capacity, and reduce disease progression. The introduction of generic riociguat provides a new source of supply in the U.S. market and may broaden access to an established therapy. According to Bayer’s 2025 Annual Report, global sales of Adempas were approximately €745 million, or about $850 million, in 2025, underscoring the commercial significance of the therapy. The launch also demonstrates the continued development of the U.S. specialty generics market, where technically complex products can create opportunities for pharmaceutical companies with specialized development and manufacturing capabilities. Zydus and MSN’s first-to-market launch of generic riociguat therefore represents a significant pharmaceutical manufacturing and market-access milestone in the treatment of pulmonary hypertension.
Source: Zydus Lifesciences press release
