Zydus Lifesciences Limited, in collaboration with MSN Laboratories Private Limited, has announced the launch of the first generic version of Adempas® (riociguat) tablets in the United States. This development marks a significant milestone as Zydus and MSN become the first companies to introduce a generic alternative to Adempas® in the U.S. market. The tablets, available in five strengths ranging from 0.5 mg to 2.5 mg, have been approved by the United States Food and Drug Administration (USFDA) as a generic equivalent to the branded product.
Riociguat is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). These conditions are rare and progressive, often requiring lifelong therapy. 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.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, highlighted the significance of this launch for both the company’s U.S. business and patients with pulmonary hypertension. He emphasised the strength of Zydus’ complex-generics pipeline and the company’s ability to execute day-one launches in specialty categories. Dr. MSN Reddy, Founder and CMD of MSN Laboratories, noted the technical challenges involved in developing riociguat and expressed confidence in the partnership’s ability to deliver a consistent, high-quality supply of the therapy.
The global sales of Adempas® were reported to be approximately EUR 745 million in 2025, according to Bayer’s Annual Report. The entry of a generic version could potentially impact the market dynamics by offering a cost-effective alternative to the branded product. Analysts will likely monitor the market response closely, as the availability of a generic could influence pricing and accessibility for patients.
