India-based pharmaceutical companies Zydus Lifesciences Limited and MSN Laboratories Private Limited announced on Monday the launch of Riociguat Tablets, 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg, in the United States.
Zydus and MSN say that they are the first companies to launch a generic version of Adempas (riociguat) in the US market. The product was developed and is manufactured by MSN.
Riociguat Tablets are approved by the US Food and Drug Administration (FDA) as a generic equivalent of Adempas Tablets in all five strengths. 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; and for adults with pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise capacity, improve WHO functional class and to delay clinical worsening.
PAH and CTEPH are rare, progressive and life-threatening conditions in which patients typically remain on therapy for life. Until now, riociguat has only been available in the United States as the branded product.
Adempas is a brand of German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY).
Sales of riociguat are not reported by IQVIA. According to Bayer's Annual Report 2025, its global sales of Adempas were approximately EUR745m (approximately USD850m) in 2025.
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