Drugmakers Zydus Lifesciences and Hyderabad-based MSN Laboratories have entered into an exclusive licensing and supply agreement for Cabozantinib Tablets, a generic version of cancer drug Cabometyx, for the U.S. market.
Under the agreement, MSN will be in charge of manufacturing and supplying the generic version, following the receipt of regulatory approval, while Zydus will exclusively market, distribute and sell the product in the U.S.
MSN was a first sole ANDA applicant for Cabozantinib Tablets to submit a substantially complete Abbreviated New Drug Application with a paragraph IV certification and thus may be eligible for 180 days of generic drug exclusivity for the version of Cabometyx, Ahmedabad-based Zydus said in a release on Friday.
The total addressable market opportunity of Cabozantinib Tablets in the U.S. is about $1,464 million, the company said citing IQVIA MAT March 2024 numbers.
“Cabozantinib tablets is an important treatment option for many cancer patients and we are pleased to work with MSN to bring the generic version of Cabometyx to the U.S. market,” Zydus Lifesciences MD Sharvil Patel said.
Zydus Lifesciences signed the agreement with MSN through wholly owned subsidiary Zydus Lifesciences Global FZE.
“As a leading global developer and manufacturer of vertically integrated generics, we are pleased to partner with Zydus on this significant first to market opportunity. We are confident that working with Zydus will allow us to successfully commercialise Cabozantinib,” founder and CMD of MSN Group MSN Reddy said.
According to U.S. FDA, Cabometyx is a kinase inhibitor used in the treatment of patients with advanced renal cell carcinoma.
