The US launch of riociguat tablets across five strengths expands the companies’ presence in specialty generics and targets two serious forms of pulmonary hypertension.
Zydus Lifesciences and MSN Laboratories have launched the first generic version of Bayer’s Adempas in the United States, introducing a generic alternative to riociguat, a prescription medicine used to treat certain forms of pulmonary hypertension.
Announced on October 5, 2026, the launch covers riociguat tablets in five strengths: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg. The US Food and Drug Administration (FDA) has approved the tablets as a generic equivalent of Adempas in all five strengths, according to the companies.
The product was developed and is manufactured by MSN Laboratories, while Zydus is responsible for its commercialisation in the US market. The partnership combines MSN’s pharmaceutical development and manufacturing capabilities with Zydus’ established commercial presence in the country.
A Generic Alternative for Two Serious Lung Conditions
Riociguat belongs to a class of medicines known as soluble guanylate cyclase stimulators. It is approved for adults with pulmonary arterial hypertension (PAH), which affects the blood vessels supplying the lungs, and chronic thromboembolic pulmonary hypertension (CTEPH), a condition associated with persistent blood clots in the lungs’ blood vessels.
For eligible patients with PAH, the medicine can improve exercise capacity and functional status and delay clinical worsening. In CTEPH, it is indicated for patients whose condition persists or recurs after surgery, or for those whose disease cannot be treated surgically, to improve exercise capacity and functional status.
Before this launch, Adempas was the only riociguat product available in the US market, according to the companies’ announcement. The introduction of a generic version creates an additional supply option, although the actual effect on treatment costs and patient access will depend on pricing, insurance coverage and market uptake.
A Specialty Generics Opportunity
The launch also highlights the commercial opportunity in complex generic medicines, where development requires specialised formulation expertise, regulatory compliance and reliable manufacturing.
According to Bayer’s 2025 annual report, Adempas generated approximately €745 million in global sales during 2025, equivalent to around US$850 million. This figure represents worldwide sales of the branded medicine, not the size of the US generic market or the revenue available to the two Indian companies.
For Zydus, the launch adds another product to its US pharmaceutical business and supports its focus on specialty and complex generics. For MSN Laboratories, it marks the commercialisation of a technically demanding medicine developed and manufactured by the company.
The longer-term commercial impact will depend on market adoption, competition, pricing and the companies’ ability to maintain a consistent supply. The launch nevertheless marks a significant entry into the US market for a generic medicine used in the treatment of two serious pulmonary hypertension conditions.
