180 days shared US FDA exclusivity for Zydus' Selexipag Tablets

Indian generics major Zydus Lifesciences (NYSE: ZYDUSLIFE), formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. This is a generic copy of Uptravi, which is marketed by Johnson & Johnson’s (NYSE: JNJ) pharmaceutical arm, Janssen.

Zydus was one of the first abbreviated new drug applicants to submit a substantially complete ANDA with a paragraph IV certification for Selexipag Tablets, at the above does and therefore is eligible for 180 days of shared generic drug exclusivity for Selexipag Tablets.

Selexipag 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 hospitalization for PAH. The drug will be manufactured in the group’s formulation manufacturing facility at Ahmedabad SEZ, India.