Zydus Lifesciences Limited (Zydus) has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, USP, 25 mg/vial, a sterile lyophilised powder for reconstitution. The product is the generic equivalent of IC-Green®, the reference listed drug marketed by Diagnostic Green LLC. The USFDA has designated Zydus’ application as a Competitive Generic Therapy (CGT). Zydus plans to launch the product shortly, which will trigger the applicable 180-day CGT exclusivity period. The exclusivity period, where applicable, is determined by the USFDA and begins from the date of first commercial marketing.
Indocyanine Green for Injection is an optical imaging agent used in fluorescence imaging of blood vessels, blood flow and tissue perfusion in a range of surgical procedures, including vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries and general minimally invasive procedures. It is also indicated for fluorescence imaging of extrahepatic biliary ducts, lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer, as well as for ophthalmic angiography.
The product is indicated for adults and, for specified indications, paediatric patients aged one month and older. The product will be manufactured at Zydus’ USFDA-approved injectable manufacturing facility at Jarod, near Vadodara, Gujarat, and marketed in the United States through Zydus Pharmaceuticals (USA) Inc.
Dr Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said: “Indocyanine Green combines pharmaceutical precision with the requirements of advanced imaging. Its development calls for close control of chromophore purity, photostability and lyophilisation. Securing this approval reflects the capabilities we have developed with our partner and our focus on maintaining high standards in complex products. The launch will expand our presence in functional dyes and imaging agents while supporting access to essential medicines and diagnostic technologies.”
The product will be supplied as a kit containing single-patient-use vials of Indocyanine Green for Injection, 25 mg, as a sterile lyophilised green powder for reconstitution, along with single-dose vials containing 10 mL of Sterile Water for Injection. According to IQVIA MAT June 2026 data, the US market for the reference product recorded annual sales of approximately US$125.8 million, representing 61.0% growth, with volumes of approximately 0.64 million units, up 27.1%. With this approval, Zydus now has 445 approvals and has filed 513 ANDAs with the USFDA as of 30 June 2026.
Zydus Lifesciences is a global life sciences company engaged in the discovery, development, manufacturing and marketing of healthcare products. The group employs more than 30,000 people worldwide, including around 1,500 scientists involved in research and development. Its portfolio spans vaccines, therapeutics, biologicals and new chemical entities, with a focus on developing healthcare solutions for unmet medical needs.
