Drugmakers Zydus Lifesciences and Hyderabad-based MSN Laboratories have entered into an unique licensing and provide settlement for Cabozantinib Tablets, a generic model of cancer drug Cabometyx, for the U.S. market.
Under the settlement, MSN might be in control of manufacturing and supplying the generic model, following the receipt of regulatory approval, whereas Zydus will completely market, distribute and promote the product within the U.S.
MSN was a primary sole ANDA applicant for Cabozantinib Tablets to submit a considerably full Abbreviated New Drug Application with a paragraph IV certification and thus could also be eligible for 180 days of generic drug exclusivity for the model of Cabometyx, Ahmedabad-based Zydus stated in a launch on Friday.
The complete addressable market alternative of Cabozantinib Tablets within the U.S. is about $1,464 million, the corporate stated 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 stated.
Zydus Lifesciences signed the settlement with MSN by means of 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 stated.
According to U.S. FDA, Cabometyx is a kinase inhibitor used within the remedy of sufferers with superior renal cell carcinoma.
