Ahmedabad – – October 05, 2026 -- Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, has launched the first generic version of riociguat in the United States, undercutting a branded drug whose maker, Bayer, reported approximately EUR 745 million (roughly USD 850 million) in global sales for 2025.

FDA clears five generic strengths matching Adempas

The U.S. Food and Drug Administration approved Riociguat Tablets in 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg doses as generic equivalents of Bayer's Adempas Tablets across all strengths. MSN developed and manufactures the product, while Zydus handles U.S. commercialization.

Drug targets two rare, life-threatening lung conditions

Riociguat is a soluble guanylate cyclase stimulator approved for adults with pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capacity, WHO functional class and delay clinical worsening. It is also indicated for persistent, recurrent or inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) following surgical treatment. Patients with these progressive conditions typically require lifelong therapy, and until this launch riociguat was available in the U.S. only as the branded product.

Executives frame launch as proof of complex-generics capability

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, called the first-to-market launch "a milestone for our U.S. business and for patients with pulmonary hypertension,