Zydus Lifesciences Ltd. announced that it has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc. for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market. Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals.
The novel 505(b)(2) product targets a significant commercial opportunity in the U.S. market, with an estimated total addressable market (TAM) of 6.2 million units, according to IQVIA data MAT September 2025.
