India-based pharmaceutical company focused on manufacturing generic drugs Zydus Lifesciences Ltd. announced on Friday that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has signed an exclusive licensing and supply agreement with Viwit Pharmaceuticals, a China-based biopharmaceutical and healthcare company.

The contract has been signed for gadobutrol injection (generic version of GADAVISTTM) and gadoterate meglumine injection (generic version of DOTAREM) for the US market. Under the terms of the agreement, Viwit will be responsible for the abbreviated new drug application (ANDA) submission, manufacturing and supplying the generic versions of GADAVISTTM and DOTAREM, following the receipt of requisite regulatory approval.

Zydus will exclusively market, distribute and sell these products in the US market. Both products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus' injectable portfolio for the US market.

The total addressable market opportunity for gadobutrol injection is estimated at USD120m and for gadoterate meglumine injection at USD117m in the US market (as per IQVIA MAT Jul - 2024).