Zydus Lifesciences Wins USFDA Approval for Generic Indocyanine Green Injection with Competitive Generic Therapy Designation
Key Insights
Zydus Lifesciences received final USFDA approval for its ANDA for Indocyanine Green for Injection, USP, 25 mg/vial, a generic equivalent of Diagnostic Green's IC-Green.
The USFDA designated the application as a Competitive Generic Therapy (CGT), making it potentially eligible for 180-day marketing exclusivity upon first commercial launch.
The reference product recorded annual U.S. sales of approximately $125.8 million with 61% year-on-year growth, according to IQVIA MAT June 2026 data.
Zydus Lifesciences Limited 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. The product is a sterile lyophilised powder for reconstitution and represents the generic equivalent of IC-Green, the reference listed drug (RLD) marketed by Diagnostic Green LLC (search). The USFDA has also designated the application as a Competitive Generic Therapy (CGT), a status that may confer eligibility for 180-day marketing exclusivity beginning from the date of first commercial marketing, subject to USFDA determination.
The approval marks a significant milestone for Zydus in the functional dye and imaging agent segment. According to IQVIA MAT June 2026 data, the reference product recorded annual sales of approximately USD 125.8 million in the United States, reflecting 61% year-on-year growth, with sales volumes reaching 0.64 million units — a 27.1% increase over the prior year.
Clinical Indications and Utility
Indocyanine Green for Injection is an optical imaging agent with a broad range of clinical applications. It is indicated for fluorescence imaging of vessels, blood flow, and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro, and reconstructive surgeries, including minimally invasive procedures. The product is also indicated for fluorescence imaging of extrahepatic biliary ducts, as well as lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer (search). Additionally, it is approved for ophthalmic angiography.
The product is indicated for use in adults and, for certain indications, in pediatric patients aged one month and older.
Manufacturing and Commercialization
The product will be manufactured at Zydus' USFDA-approved injectable manufacturing facility at Jarod, near Vadodara in Gujarat, and will be marketed in the United States through Zydus Pharmaceuticals (USA) Inc. The product will be supplied as a kit containing single-patient-use vials of indocyanine green for injection, 25 mg, as a sterile, lyophilized green powder for reconstitution, together with single-dose vials of sterile water for injection, 10 ml.
Executive Commentary
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, commented on the approval: "Indocyanine green sits at the intersection of medicine and imaging science, requiring precise control of chromophore purity, photostability and lyophilisation. Developing and securing approval for such a complex product with our partner reflects the capabilities we have built and our shared commitment to high standards. It also advances our goal of making essential medicines and diagnostics more accessible, while strengthening our presence in the functional dye and imaging agent segment, where we continue to invest."
Portfolio Growth and Strategic Positioning
The approval adds to the Zydus Group's portfolio of complex injectable and imaging products and reflects a development model applied across that portfolio: internal formulation and analytical capability combined with an external partner selected for the particular program. Zydus continues to invest in the functional dye and imaging agent segment.
With this latest approval, the Zydus Group now holds 445 USFDA approvals and has filed 513 ANDAs as of June 30, 2026.