Zydus Lifesciences Limited and MSN Laboratories Private Limited have successfully launched the first generic version of Adempas (Riociguat tablets) in the US market, according to a regulatory filing. The partnership has achieved this milestone by developing and manufacturing the generic equivalent of the original medication, marking a significant development in the pharmaceutical industry's access to this specialized treatment. As per PRNewswire, this launch represents the first generic version of Adempas® (riociguat) in the U.S. market, with the product being developed and manufactured by MSN Laboratories and approved by the US Food and Drug Administration (USFDA) as a generic equivalent of Adempas tablets in all five strengths.
The launch encompasses Riociguat tablets in all five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg, as reported by the regulatory filing. The product was developed and manufactured by MSN Laboratories and has received approval from the US Food and Drug Administration (USFDA) as a generic equivalent of Adempas tablets. This comprehensive coverage across dosage strengths ensures broad market accessibility for the generic version, with the partnership being the first companies to launch a generic version of Adempas® (riociguat) in the U.S. market and the first generic alternative to Adempas® in the United States. The introduction of a generic version is expected to provide a more affordable option for patients in the U.S., who previously had access only to the branded version of the medication. As noted by the companies, until now, riociguat was available in the US only as the branded product, making this launch particularly significant for patients with these rare conditions.
Riociguat is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of 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. Additionally, it is indicated for adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to delay clinical worsening, as detailed in the regulatory filing. According to PRNewswire, PAH and CTEPH are rare, progressive and life-threatening conditions in which patients typically remain on therapy for life, with riociguat being available in the United States only as the branded product until now. For patients with CTEPH, the drug is indicated after persistent or recurrent disease following surgery, or when the condition cannot be treated through surgery. For PAH, it is used to improve exercise capacity and functional status and delay clinical worsening, making access to lower-cost versions particularly significant for these patients.
According to Bayer's Annual Report 2025, global sales of Adempas were approximately EUR 745 million (approximately USD 850 million) in 2025. This substantial market size provides significant opportunity for the generic version, with the partnership positioning itself to capture a portion of this established revenue base in the US market. The entry of a generic version could potentially impact market dynamics by offering a cost-effective alternative to the branded product, as noted by PRNewswire. Analysts will likely monitor the market response closely, as the availability of a generic could influence pricing and accessibility for patients seeking treatment for these rare and progressive conditions. The launch opens the market to a lower-cost alternative for patients with certain forms of pulmonary hypertension, making treatment more accessible for patients who typically remain on therapy for life.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, stated that being the 'first to market with generic riociguat is a milestone for our U.S. business and for patients with pulmonary hypertension', reflecting the strength of their complex-generics pipeline and execution capabilities. He emphasized that enabling access to the drug across all five strengths allows physicians and pharmacies to transition patients with confidence, and highlighted the strength of Zydus's complex-generics pipeline and the company's ability to execute day-one launches in specialty categories. Dr. MSN Reddy, Founder & CMD of MSN Laboratories, noted that bringing the first generic of the technically-demanding molecule demonstrates the depth of MSN's integrated API and formulation R&D and manufacturing scale, expressing confidence in the partnership's ability to deliver a consistent, high-quality supply of the therapy. The partnership combines Zydus's established U.S. commercial platform with MSN's manufacturing capabilities to deliver this important therapy to patients.
