Zydus Cadila gains 180-day exclusivity for Xeljanz generic in USA

23 August 2021

Zydus Cadila, a part of Cadila Healthcare (BOM: 532321), today announced it has received final approval from the US Food and Drug Administration to market a generic version of US pharma giant Pfizer’s (NYSE: PFE) KAK inhibitor Xeljanz XR (tofacitinib) extended-release tablets, 11mg and 22mg in the USA.

Zydus was the first Abbreviated New Drug Application (ANDA) filer on tofacitinib extended-release tablets 22mg and currently holds 180-day exclusivity on this strength.

Tofacitinib extended-release tablets had annual sales of around $2,082 million in the USA for the year ending June 2021 according to IQVIA data. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

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