Zydus Lifesciences and MSN Laboratories have launched the first generic version of Adempas (riociguat) in the US, opening the door to a lower-cost treatment option for patients with pulmonary hypertension.

 

The companies said they have launched Riociguat Tablets in all five strengths — 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg — making them the first companies to bring a generic version of the drug to the U.S. market.

 

The product was developed and manufactured by MSN Laboratories and has been approved by the US Food and Drug Administration as a generic equivalent of Adempas tablets across all five strengths.

 

Riociguat is a soluble guanylate cyclase (sGC) stimulator used to treat 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), with the aim of improving exercise capacity and WHO functional class and delaying clinical worsening.

 

Calling the launch a milestone for the company's US business, Zydus Lifesciences Managing Director Sharvil Patel said, "Being first to market with generic riociguat is a milestone for our U.S. business and for patients with pulmonary hypertension. 

 

"It reflects the strength of our complex-generics pipeline, our ability to execute day-one launches in specialty categories, and the strength of our partnerships that complement our commercial reach in the United States. We are pleased to enable access to the drug across all five strengths, allowing physicians and pharmacies to transition patients with confidence."

 

MSN Laboratories Founder and CMD MSN Reddy said the launch highlights the company's capabilities in developing and manufacturing complex therapies.

 

"Riociguat is a technically demanding molecule, and bringing the first generic to the US demonstrates the depth of MSN's integrated API and formulation R&D and the scale of our manufacturing. Together with Zydus' established US commercial platform, we are confident of delivering consistent, high-quality supply of this important therapy."

 

The first-to-market launch strengthens Zydus' presence in the US specialty-generic market while leveraging MSN's development and manufacturing capabilities.