Zydus Lifesciences Ltd on Thursday said its subsidiary Zydus Worldwide DMCC has received final approval from the US health regulator to market its generic version of Selexipag tablets with 180 days of shared exclusivity.
The approval granted by the US Food and Drug Administration (USFDA) is to market Selexipag tablets of strengths 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg, the company said in a regulatory filing.
Zydus said it was one of the first ANDA (Abbreviated New Drug Application) applicants to “submit a substantially complete ANDA with a paragraph IV certification” for the Selexipag tablets and “and therefore is eligible for 180 days of shared generic drug exclusivity”.
Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) to delay disease progression and reduce the risk of hospitalisation, the company said.
The drug will be manufactured in the group’s formulation manufacturing facility at Ahmedabad SEZ.
Selexipag tablet had annual sales of USD 577 million in the US, the company said, citing IQVIA data for September 2022. PTI RKL ABM ABM
