Zydus Lifesciences has entered an exclusive licensing and commercialization agreement with RK Pharma for a novel sterile injectable oncology supportive care product in the US market. RK Pharma will manufacture and supply the finished product, while Zydus will handle NDA submission and commercialization. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026.
Partnership for Oncology Treatment
Zydus Lifesciences Ltd. has announced an exclusive agreement with RK Pharma Inc of the US to license and commercialize a novel sterile injectable 505(b)(2) oncology supportive care product in the US market. The announcement was made on November 26, 2025.
Terms of the Agreement
Under the agreement, RK Pharma will manufacture and supply the product. Zydus will be responsible for the NDA submission and its commercialization in the United States. The product is developed under the 505(b)(2) pathway and is anticipated to be filed in 2026. The new formulation is designed to minimize dosing errors and improve compliance among healthcare professionals.
Management Commentary
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, stated the collaboration with RK Pharma will bring innovative products to patients in the US. He highlighted the partnership reinforces the commitment to providing affordable medicines and improving patient care.
Dr. Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, emphasized the novel 505(b)(2) product is a testament to RK Pharma’s advanced capabilities. The collaboration with Zydus aims to ensure the therapeutic option reaches patients, thus reinforcing their shared mission to improve access to high-quality healthcare in the USA.
Market Opportunity
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.
Source: BSE
