Indocyanine Green Patent Expiration

Indocyanine Green is used for visualizing blood flow in various surgical procedures and organ transplants. It was first introduced by Renew Pharmaceuticals Ltd in its drug Ic-Green on Approved Prior to Jan 1, 1982. Other drugs containing Indocyanine Green are Zyogreen, Spy Agent Green Kit. 4 different companies have introduced drugs containing Indocyanine Green.


Indocyanine Green Patents

Given below is the list of patents protecting Indocyanine Green, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Spy Agent Green Kit US11712320 Methods and systems to automate surgical interventions Jul 14, 2039 Novadaq Tech
Spy Agent Green Kit US10631746 Quantification of absolute blood flow in tissue using fluorescence-mediated photoplethysmography Aug 04, 2035 Novadaq Tech
Spy Agent Green Kit US8406860 Method for evaluating blush in myocardial tissue Apr 09, 2029 Novadaq Tech
Spy Agent Green Kit US8647605 Real time imaging during solid organ transplant Feb 11, 2029 Novadaq Tech
Spy Agent Green Kit US8185176 Method and apparatus for vasculature visualization with applications in neurosurgery and neurology Jun 04, 2028 Novadaq Tech
Spy Agent Green Kit US9421280 Real time imaging during solid organ transplant Nov 24, 2025

(Expired)

Novadaq Tech
Spy Agent Green Kit US7881777 Method and apparatus for performing intra-operative angiography Sep 22, 2021

(Expired)

Novadaq Tech
Spy Agent Green Kit US6915154 Method and apparatus for performing intra-operative angiography Aug 01, 2021

(Expired)

Novadaq Tech
Spy Agent Green Kit US8892190 Method and apparatus for performing intra-operative angiography Aug 11, 2020

(Expired)

Novadaq Tech



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Indocyanine Green's patents.

Given below is the list recent legal activities going on the following patents of Indocyanine Green.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 11 Sep, 2024 US8406860
Payment of Maintenance Fee, 8th Year, Large Entity 07 Feb, 2024 US9421280
Payment of Maintenance Fee, 4th Year, Large Entity 11 Oct, 2023 US10631746
Recordation of Patent eGrant 01 Aug, 2023 US11712320
Mail Patent eGrant Notification 01 Aug, 2023 US11712320
Patent eGrant Notification 01 Aug, 2023 US11712320
Patent Issue Date Used in PTA Calculation 01 Aug, 2023 US11712320
Email Notification 01 Aug, 2023 US11712320
Electronic Review 01 Aug, 2023 US11712320
Recordation of Patent Grant Mailed 01 Aug, 2023 US11712320


Indocyanine Green's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Indocyanine Green:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Sentinel Node Biopsy in Endometrial Cancer Queensland Centre for Gynaecological Cancer NA RECRUITING
(Sep 1, 2026)
PHASE3
Indocyanine Green (ICG) Guided Tumor Resection St. Jude Children's Research Hospital NA COMPLETED
(Sep 1, 2026)
PHASE1
Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI) OPTOSURGICAL, LLC NA TERMINATED
(Sep 1, 2026)
PHASE1
Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery City of Hope Medical Center NA COMPLETED
(Aug 1, 2026)
PHASE1
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery Institut de Cancérologie de Lorraine NA COMPLETED
(Aug 1, 2026)
PHASE3
A Study of Intra-operative Imaging in Women With Ovarian Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Magnetic Sentinel Lymph Node Mapping in Gastric Cancer M.D. Anderson Cancer Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship The University of Texas Health Science Center, Houston NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat Syndrome Xiang-Qian NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
ICG Fluorescence in Knee Arthroscopy Study Henry Ford Health System NA RECRUITING
(Aug 1, 2026)
PHASE1
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy NYU Langone Health NA COMPLETED
(Jul 1, 2026)
PHASE1
Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors Medical University of South Carolina NA RECRUITING
(Jul 1, 2026)
PHASE2
Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial City of Hope Medical Center NA RECRUITING
(Jun 1, 2026)
PHASE2
Intraoperative Tumor Margin Identification With ICG Dye Imaging Massachusetts General Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2
Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia Boston Children's Hospital NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
TumorGlow Intraoperative Molecular Imaging (IMI) University of Pennsylvania NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging. Johns Hopkins University NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1


Indocyanine Green Generic API Manufacturers

Several generic applications have been filed for Indocyanine Green. The first generic version for Indocyanine Green was by Renew Pharmaceuticals Ltd and was approved on Nov 21, 2007. And the latest generic version is by Zydus Lifesciences Global Fze and was approved on Aug 3, 2026.

Given below is the list of companies who have filed for Indocyanine Green generic, along with the locations of their manufacturing plants worldwide.