Zydus Lifesciences received USFDA approval for generic Indocyanine Green for Injection with Competitive Generic Therapy designation and 180-day exclusivity.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration 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® (Diagnostic Green LLC). The USFDA has designated the application as a Competitive Generic Therapy (CGT). Where applicable, the designation provides eligibility for 180 days of marketing exclusivity, with the exclusivity period beginning from the date of the product’s first commercial marketing.
Approved Clinical Indications for Fluorescence Imaging
Indocyanine Green for Injection is an optical imaging agent approved for fluorescence imaging of vessels, blood flow, and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro, reconstructive, and minimally invasive surgical procedures. It is also indicated for fluorescence imaging of extrahepatic biliary ducts, lymphatic mapping in adults with cervical and uterine cancers, and ophthalmic angiography. While the product is primarily indicated for adults, certain approved indications also extend to pediatric patients aged one month and older.
Manufacturing and US Commercialisation Strategy
The approved product will be manufactured at Zydus’ USFDA-approved injectable manufacturing facility in Jarod, Gujarat, and commercialised in the United States through Zydus Pharmaceuticals (USA) Inc. The company plans to launch the product shortly, which will trigger the commencement of the 180-day CGT exclusivity period. The injectable will be supplied as a kit containing a single-patient-use 25 mg vial of Indocyanine Green for Injection together with a single-dose vial of Sterile Water for Injection (10 mL) for reconstitution.
Executive Perspective
Commenting on the approval, Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said that developing indocyanine green required precise control of chromophore purity, photostability, and lyophilisation, reflecting the company’s growing expertise in complex injectable formulations. He added that achieving approval for such a complex product with its development partner demonstrates the capabilities Zydus has built while advancing its commitment to making essential medicines and diagnostic products more accessible. According to Patel, the approval also strengthens the company’s presence in the functional dye and imaging agent segment, where it continues to invest.
Portfolio Expansion and Market Opportunity
The approval further expands Zydus’ portfolio of complex injectable and imaging products. It also reflects the company’s development strategy of combining in-house formulation and analytical expertise with an external development partner selected for the specific programme. Zydus stated that it continues to invest in the functional dye and imaging agent segment as part of its broader complex injectable strategy.
According to IQVIA MAT June 2026 data, the reference product generated approximately USD 125.8 million in annual U.S. sales, representing 61.0% year-over-year value growth, while unit volumes increased 27.1% to approximately 0.64 million units, highlighting a growing commercial opportunity in the surgical imaging market.
Regulatory Milestone Strengthens US Generic Portfolio
The latest approval increases Zydus’ cumulative USFDA approvals to 445, while the company had filed 513 ANDAs as of June 30, 2026. The Competitive Generic Therapy designation provides eligibility for 180 days of exclusivity following first commercial marketing, as determined by the USFDA, further strengthening Zydus’ portfolio of complex generic injectable products.
Reference
Microsoft Word – Press Release_ZLL USFDA Indocyanine Green Injection
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.
