Zydus Lifesciences announced today that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive licensing and supply agreement with Vivit Pharmaceuticals (Vivit). This agreement covers the US market for gadobutrol injection (generic version of GADAVIST™) and gadoterate meglumine injection (generic version of DOTAREM®).
Under the terms of the agreement, Vivit will handle ANDA submission, manufacturing, and supply of these generic MRI contrast agents, pending regulatory approval. Zydus will take charge of marketing, distribution, and sales of these products within the US. This marks the first inclusion of Gadolinium-based MRI contrast agents in Zydus’ injectable portfolio for the US market.
The total addressable market for gadobutrol injection is estimated at $120 million, while gadoterate meglumine injection is valued at $117 million in the US, according to IQVIA MAT data from July 2024.
