Zydus Cadila gets 180-day exclusivity for Nelarabine injection, announces final approval from US FDA

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market Nelarabine injection 250mg/50ml in the US. Zydus was granted a Competitive Generic Therapy (CGT) designation for Nelarabine injection, 250 mg/50 mL (5 mg/mL), single-dose vial. It is the “first approved applicant” for Nelarabine injection, 250 mg/50 mL (5 mg/mL), single-dose vial, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act. Therefore, with this approval, Zydus is eligible for 180 days of CGT exclusivity for Nelarabine injection, 250 mg/50 mL (5 mg/mL), single-dose vial, under section 505(j)(5)(B)(v) of the FD&C Act, the company said in a statement.

It also said that Nelarabine injection had annual sales of approximately $34.5 million in the US, according to IQVIA data (September 2021). The drug is manufactured at the group’s injection manufacturing facility, Alidac plant in Ahmedabad and shall be launched commercially within the US market immediately.

This medication is a chemotherapy drug and used to treat certain types of leukemia and lymphoma by slowing or stopping the growth of cancer cells. Nelarabine is in a class of medications called antimetabolites, added the statement.

Speaking on the development, Dr Sharvil Patel, Managing Director, Cadila Healthcare, said, “This FDA approval of Nelarabine injection underlines our long-term commitment to patients of providing them access to affordable generics. This approval builds on our proven track record of successfully commercialising and gaining meaningful market share in complex generics products. We have created a diversified portfolio of more than 50 filed complex ANDAs and will continue to focus on complex generic products as we continue to explore opportunities to grow our US business.”

Zydus, in addition to their complex injectable products, has created an industry-leading portfolio of difficult-to-develop oral solids, drug-device combinations, topicals and transdermal patch products. The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.