Zydus Cadila obtains FDA nod for generic Imbruvica

The Food and Drug Administration has cleared Zydus Cadila’s Ibrutinib capsules, in dosage strengths of 70 mg and 140 mg.

The product is the generic of Imbruvica capsules.

It belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for the 70 mg product. Therefore, Zydus is eligible for 180 days of generic drug exclusivity for the product.

The 70-mg capsule has a market value of $32.5 million, while the 140-mg dose has brand sales of  $745.9 million.

“This FDA approval of Ibrutinib capsules reinforces our long-term commitment to provide patients and caregivers access to affordable therapies. We have been investing significantly in building a portfolio of complex generic products and leveraging capabilities that will help us successfully commercialize and gain meaningful market share in the complex generic products and difficult-to-manufacture generic products. We have created a diversified portfolio of over 50 filed complex ANDAs seeking USFDA approval and we will continue to expand this as we explore opportunities to grow our U.S. business in 2021 and beyond,” said Zydus group managing director, Sharvil Patel.

The drug will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad.