Indocyanine green - Generic Drug Details

What are the generic drug sources for indocyanine green and what is the scope of freedom to operate?

Indocyanine green is the generic ingredient in four branded drugs marketed by Renew Pharms, Zydus Lifesciences, Novadaq Tech, and Provepharm Sas, and is included in five NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for indocyanine green

International Patents:	56
US Patents:	5
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	256
Patent Applications:	7,154
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for indocyanine green
What excipients (inactive ingredients) are in indocyanine green?	indocyanine green excipients list
DailyMed Link:	indocyanine green at DailyMed

Recent Clinical Trials for indocyanine green

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Nada Mahmoud Soliman	PHASE2
The University of Hong Kong	PHASE3
Medical University of South Carolina	PHASE2

See all indocyanine green clinical trials

Generic filers with tentative approvals for INDOCYANINE GREEN

Applicant	Application No.	Strength	Dosage Form
		40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION
		10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION
		50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for indocyanine green

Coloring Agents

Anatomical Therapeutic Chemical (ATC) Classes for indocyanine green

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

Paragraph IV (Patent) Challenges for INDOCYANINE GREEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPY AGENT GREEN KIT	For Injection	indocyanine green	25 mg/vial	211580	1	2022-11-28

US Patents and Regulatory Information for indocyanine green

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes
Provepharm Sas	ZYOGREEN	indocyanine green	SOLUTION;INTRAVENOUS, INTERSTITIAL	218579-001	Jul 10, 2026		RX	Yes	Yes
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	No
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes			Y
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for indocyanine green

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018

International Patents for indocyanine green

Country	Patent Number	Title	Estimated Expiration
Australia	2014408488	Quantification of absolute blood flow in tissue using fluorescence-mediated photoplethysmography
Australia	2019250179	QUANTIFICATION OF ABSOLUTE BLOOD FLOW IN TISSUE USING FLOURESCENCE-MEDIATED PHOTOPLETHYSMOGRAPHY
Canada	2963450	QUANTIFICATION DE CIRCULATION SANGUINE ABSOLUE DANS UN TISSU A L'AIDE DE PHOTOPLETHYSMOGRAPHIE INDUITE PAR FLUORESCENCE (QUANTIFICATION OF ABSOLUTE BLOOD FLOW IN TISSUE USING FLUORESCENCE-MEDIATED PHOTOPLETHYSMOGRAPHY)
China	107427247	使用荧光介导的光电容积描记法的组织中的绝对血液流动的定量 (QUANTIFICATION OF ABSOLUTE BLOOD FLOW IN TISSUE USING FLUORESCENCE-MEDIATED PHOTOPLETHYSMOGRAPHY)
European Patent Office	3203902	QUANTIFICATION DE CIRCULATION SANGUINE ABSOLUE DANS UN TISSU À L'AIDE DE PHOTOPLÉTHYSMOGRAPHIE INDUITE PAR FLUORESCENCE (QUANTIFICATION OF ABSOLUTE BLOOD FLOW IN TISSUE USING FLUORESCENCE-MEDIATED PHOTOPLETHYSMOGRAPHY)
European Patent Office	3915467	QUANTIFICATION DE CIRCULATION SANGUINE ABSOLUE DANS UN TISSU À L'AIDE DE PHOTOPLÉTHYSMOGRAPHIE INDUITE PAR FLUORESCENCE (QUANTIFICATION OF ABSOLUTE BLOOD FLOW IN TISSUE USING FLUORESCENCE-MEDIATED PHOTOPLETHYSMOGRAPHY)