Zydus Lifesciences Limited (NSE:ZYDUSLIFE) announced on 4 August 2026 that it has received final approval from the USFDA for its ANDA for Indocyanine Green for Injection, USP, 25 mg/vial, carrying 180-day Competitive Generic Therapy exclusivity, with a commercial launch in the United States planned shortly.
Key Highlights
- The USFDA granted final approval for Zydus Lifesciences' ANDA for Indocyanine Green for Injection, USP, 25 mg/vial, a sterile lyophilised powder for reconstitution.
- The USFDA has designated the application a Competitive Generic Therapy, making the product eligible for 180-day CGT exclusivity beginning from the date of first commercial marketing.
- The product is the generic equivalent of IC-Green by Diagnostic Green LLC, whose US annual brand sales stood at approximately USD 125.8 million, a growth of 61.0%, as per IQVIA MAT June 2026 data.
- Manufacturing will be carried out at the group's USFDA-approved injectable plant at Jarod, near Vadodara, Gujarat, and the product will be marketed in the US by Zydus Pharmaceuticals (USA) Inc.
About the Company
Zydus Lifesciences Limited, listed on NSE under the ticker ZYDUSLIFE and headquartered in Ahmedabad, Gujarat, is an innovative global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 30,000 people worldwide, including approximately 1,500 scientists in research and development, and operates across pharmaceuticals, biologicals, vaccines, and new chemical entities, serving patients in the United States, India, and other international markets.
Announcement in Detail
The USFDA's final approval covers Zydus Lifesciences' ANDA for Indocyanine Green for Injection, USP, 25 mg/vial, formulated as a sterile lyophilised green powder supplied as a kit with single-dose vials of Sterile Water for Injection, 10 ml. The product is indicated for fluorescence imaging of vessels, blood flow, tissue perfusion, extrahepatic biliary ducts, lymph nodes, and lymphatic vessels, and for ophthalmic angiography, in adults and paediatric patients aged one month and older for certain indications.
The USFDA designated the application a Competitive Generic Therapy. The 180-day CGT exclusivity period, where applicable, runs from the date of first commercial marketing as determined by the USFDA. The reference listed drug, IC-Green by Diagnostic Green LLC, recorded US annual brand sales of approximately USD 125.8 million, representing 61.0% value growth and volume growth of 27.1%, totalling 0.64 million units, per IQVIA MAT June 2026 data. As of 30 June 2026, Zydus holds 445 USFDA approvals from 513 ANDAs filed.
Impact on Investors
The filing shows that the 180-day CGT exclusivity, where it applies, provides a defined period during which Zydus faces limited generic competition for Indocyanine Green for Injection in the United States. Investors will note that the exclusivity period is triggered by the date of first commercial marketing, and the announcement states a launch is planned shortly, though no specific launch date has been confirmed in the filing.
Shareholders will observe that the brand market for the reference drug recorded approximately USD 125.8 million in annual US sales as of IQVIA MAT June 2026, providing context for the addressable opportunity. The disclosed terms indicate the product adds to Zydus' complex injectable and imaging agent portfolio, which the company has identified as a continued area of investment.
Sector / Market Context
The US generic pharmaceuticals market is shaped significantly by USFDA designations such as Competitive Generic Therapy, introduced under the FDA Reauthorization Act of 2017 to accelerate generic entry in markets with limited competition. Indocyanine Green is an established optical imaging agent used in minimally invasive surgical procedures, a segment that has expanded alongside growth in laparoscopic and robotic surgical volumes in the United States.