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IC-GREEN

NDA

INDOCYANINE GREEN | N011525 | RENEW PHARMACEUTICALS LTD

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2024-P-3699 · 4 docket documents Zydus Pharmaceuticals (USA) Inc. filed this petition on August 2, 2024, requesting that the FDA determine whether IC-GREEN (indocyanine green for injection, USP) 25 mg (NDA 011525), held by Renew Pharmaceuticals Ltd., was withdrawn from the market for reasons of safety or effectiveness under 21 CFR	505(q)	2024-08-05	Granted	Zydus Pharmaceuticals (USA) Inc.
Citizen Petition from Foley & Lardner LLP FDA-2018-P-1734 · 5 docket documents Foley & Lardner LLP filed this citizen petition under 21 CFR 10.30 and 21 CFR 314.161 requesting that the FDA determine whether Akorn Inc. voluntarily withdrew IC-GREEN (Indocyanine Green) Injection in 10mg/vial, 40mg/vial, and 50mg/vial strengths (NDA 011525) from the commercial market for safety o	505(q)	2018-05-03	Granted	Foley & Lardner LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

135 trials from ClinicalTrials.gov — 6 recruiting, 4 active, 85 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer NCT00264602	Phase 1	Active	Dana-Farber Cancer Institute	57	2009-02-18 → 2029-12-01
Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions NCT02802553	N/A	Active	Case Comprehensive Cancer Center	2	2017-12-28 → 2024-12
Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy NCT04340752	Phase 1	Active	NYU Langone Health	20	2021-01-27 → 2025-09-01
PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer NCT01737619	N/A	Active	M.D. Anderson Cancer Center	101	2013-04-03 → 2028-12-31
Synapse 3D With Intravascular Indocyanine Green NCT03953144	Phase 1/2	Recruiting	St. Joseph's Healthcare Hamilton	32	2022-12-01 → 2026-12-31
Bronchial NIR Image-guided Resection NCT03097575	Phase 1/2	Recruiting	Massachusetts General Hospital	100	2015-01-06 → 2029-01-01
Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer NCT02570815	Phase 1	Recruiting	St. Joseph's Healthcare Hamilton	250	2016-10 → 2026-12
Indocyanine Green (ICG) Guided Tumor Resection NCT04084067	Phase 1	Recruiting	St. Jude Children's Research Hospital	230	2020-02-07 → 2027-12-31
Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)NCT03760575	Phase 1	Recruiting	Abramson Cancer Center at Penn Medicine	20	2023-01-10 → 2027-02-01
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma NCT03941756	N/A	Recruiting	M.D. Anderson Cancer Center	252	2018-08-14 → 2027-12-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

WEYLCHEM ORGANICA GMBHINDOCYANINE GREEN DRUG SUBSTANCE

DMF 196012006

BIOPHORE INDIA PHARMACEUTICALS PVT LTDINDOCYANINE GREEN

DMF 366472021

ICROM SRLINDOCYANINE GREEN

DMF 381042023

MACSEN DRUGSINDOCYANINE GREEN USP

DMF 401642024

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)INDOCYANINE GREEN, USP

DMF 402952024

NANTONG JINGHUA PHARMACEUTICAL CO LTDINDOCYANINE GREEN

DMF 406052024

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDINDOCYANINE GREEN USP

DMF 430852025

DISTILLATION PROD INDS DIV EASTMAN KODAK COInactiveINDOCYANINE GREEN

DMF 2941958

PCASInactiveINDOCYANINE GREEN

DMF 194232006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 24, 2026	SUPPL -43	View Letter (PDF)
Dec 6, 2024	SUPPL -39	View Letter (PDF)
Feb 9, 2023	SUPPL -31	View Letter (PDF)
Sep 27, 2006	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982