Zydus Lifesciences and RK Pharma Sign Exclusive US Licensing Deal
Filing Summary
Zydus Lifesciences Ltd. has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc. for a novel 505(b)(2) oncology supportive care product targeting the US market. Under the agreement, RK Pharma will manufacture and supply the product, while Zydus will handle NDA submission and commercialization. The product is expected to be filed in 2026. The agreement addresses a significant commercial opportunity with an estimated total addressable market of 6.2 million units in the US, as per IQVIA data from September 2025.
On November 26, 2025, Zydus Lifesciences Ltd. announced an exclusive licensing and commercialization agreement with RK Pharma Inc. for a novel 505(b)(2) oncology supportive care product in the US market. The agreement involves RK Pharma manufacturing and supplying the finished product, while Zydus will be responsible for the New Drug Application (NDA) submission and commercialization in the US.
The product, developed under the 505(b)(2) regulatory pathway, is anticipated to be filed in 2026. It is designed to provide a formulation that aims to reduce dosing errors and enhance compliance among healthcare professionals. The agreement targets a significant commercial opportunity in the US market, with an estimated total addressable market of 6.2 million units, according to IQVIA data as of September 2025.
The collaboration between Zydus and RK Pharma highlights the strategic focus on oncology supportive care, leveraging RK Pharma’s manufacturing capabilities and Zydus’s regulatory and commercial expertise. The partnership is structured to ensure efficient delivery of the therapeutic option to patients in the US.
RK Pharma Inc. is a US-based pharmaceutical company specializing in the development, manufacturing, and commercialization of complex generic products. The company focuses on challenging dosage forms, including sterile injectables and ophthalmic formulations, and operates manufacturing facilities in New York, New Jersey, and India.
Zydus Lifesciences Ltd. is a global lifesciences company engaged in discovering, developing, and marketing a wide range of healthcare therapies. The company maintains a significant presence in cancer-related therapies and employs over 29,000 people worldwide, including 1,500 scientists dedicated to research and development. Zydus is committed to delivering quality healthcare solutions that impact lives.