Zydus Lifesciences Expands US Portfolio with Exclusive Cabozantinib Agreement

Zydus Lifesciences Ltd., a prominent Indian pharmaceutical company renowned for its innovation, announced a significant agreement for the US market. Zydus Lifesciences Global FZE, a wholly-owned subsidiary, has entered an exclusive licensing and supply agreement with MSN Laboratories for Cabozantinib Tablets, the generic version of the established drug CABOMETYX®.

Strategic Partnership for US Market Entry

This strategic collaboration leverages the strengths of both companies. MSN Laboratories, with its established manufacturing capabilities, will be responsible for producing the generic Cabozantinib Tablets following the all-important regulatory approval from the US Food and Drug Administration (FDA). Zydus Lifesciences, on the other hand, will leverage its extensive US market experience to exclusively market, distribute, and sell the product throughout the country.

Potential for Exclusivity and Market Access

The agreement holds particular significance as MSN Laboratories was the first applicant to submit a substantially complete Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Cabozantinib Tablets. This positioning may grant MSN Laboratories 180 days of marketing exclusivity for the generic version upon receiving FDA approval, a valuable advantage in the competitive US market.

Addressing a High-Value Market Opportunity

The generic Cabozantinib Tablets target a substantial market opportunity in the US. According to IQVIA MAT data for March 2024, the total addressable market for this medication is estimated at approximately USD 1.464 billion, highlighting the significant potential for Zydus Lifesciences and MSN Laboratories.

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