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Indocyanine green - Generic Drug Details

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What are the generic drug sources for indocyanine green and what is the scope of indocyanine green patent protection?

Indocyanine green is the generic ingredient in three branded drugs marketed by Akorn, Diagnostic Green, and Novadaq Tech, and is included in three NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indocyanine green has sixty-eight patent family members in sixteen countries.

There are three drug master file entries for indocyanine green. Seven suppliers are listed for this compound.

Summary for indocyanine green

International Patents:	68
US Patents:	7
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Suppliers / Packagers:	7
Bulk Api Vendors:	65
Clinical Trials:	153
Patent Applications:	5,924
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for indocyanine green
DailyMed Link:	indocyanine green at DailyMed

Pharmacology for indocyanine green

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

Medical Subject Heading (MeSH) Categories for indocyanine green

Coloring Agents

Synonyms for indocyanine green

1H-Benz(e)indolium, 2-(7-(1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz(e)indol-2-ylidene)-1,3,5-heptatrien-1-yl)-1,1-dimethyl-3-(4-sulfobutyl)-, inner salt, sodium salt (1:1)

1H-Benz(e)indolium, 2-(7-(1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz(e)indol-2-ylidene)-1,3,5-heptatrienyl)-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt

1H-Benz(e)indolium, 2-(7-(1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz(e)indol-2-ylidene)-1,3,5-heptatrienyl)-1,1-dimethyl-3-(4-sulfobutyl)-, inner salt, sodium salt

1H-Benz[e]indolium,2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, inner salt, sodiumsalt

2-(7-(1,1-Dimethyl-3-(4-sulfobutyl)benz(e)indolin-2-ylidene)-1,3,5-heptatrienyl)-1,1-dimethyl-3-(4-sulfobutyl)-1H-benz(e)indolium hydroxide, inner salt, sodium salt

2-(7-(1,3-Dihydro-1,1-dimethyl-3-(4-sulfobutyl)benz(e)indolin-2-ylidene)-1,3,5-heptatrienyl)-1,1-dimethyl-3-(4-sulfobutyl)-1H-benz(e)indoliumhydroxide inner sodium salt

2-[7-[1,3-Dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e]indol-2-ylidene]-1,3,5-heptatrien-1-yl]-1,1-dimethyl-3-(4-sulfobutyl)-1H-benz[e]indolium Inner Salt Sodium Salt

2475AH

3599-32-4

4,5-Benzoindotricarbocyanine

58984-23-9

A823083

AC1L2DMU

AC1NR00S

AC1NR4PA

AK116044

AKOS000813771

AKOS015896404

AKOS016010308

Anhydro-3,3,3',3'-tetramethyl-1,1'-bis(4-sulfobutyl)-4,5,4',5'-dibenzoindotricarbocyanine hydroxide inner salt sodium salt

AS-11023

C-23505

C43H47N2O6S2.Na

Cardio Green

Cardio-Green

Cardiogreen

Cardiogreen, for microscopy

Cardiogreen, polymethine dye

CAS-3599-32-4

CC-29507

CHEBI:31696

CHEMBL1646

CS-3173

D01342

DB09374

DSSTox_CID_3145

DSSTox_GSID_23145

DSSTox_RID_76889

DTXSID2023145

EINECS 222-751-5

F9995-0163

Fox Green

Foxgreen

GT1409

GTPL4844

HMS2231C04

HSDB 3413

HWD Indocyanine Green

HY-D0711

I0535

I06-1999

IC Green

IC-Green

IC-Green (TN)

ICG

Indocyanin Green

Indocyanine Green (~90%)

Indocyanine green (JAN/USP)

Indocyanine green [USAN:JAN]

Indocyanine green [USP:JAN]

Indocyanine green, United States Pharmacopeia (USP) Reference Standard

Indocyanine green(Cardiogreen)

IndocyanineGreen

IR 125

IX6J1063HV

KB-52650

KS-00000YFZ

LS-33467

MFCD00013078

MLS001336047

MLS001336048

MLS006011677

MOFVSTNWEDAEEK-UHFFFAOYSA-M

MOLI001001

MolPort-019-996-360

MolPort-044-724-056

Natrium 4-(2-(7-(2,3-Dihydro-1,1-dimethyl-3-(4-sulfobutyl)-1H-benz(e)indol-2-yliden)-1,3,5-heptatrienyl)-1,1-dimethyl-1H-benz(e)indol-3-ol)butan-1-sulfonat

NCGC00181024-01

NK 1611

NK 2611

NK 2612

Opthagreen

potassium 2-{7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-2-ylidene]hepta-1,3,5-trien-1-yl}-1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium

RL03361

SC-09892

SCHEMBL16027582

SCHEMBL23630

SMR000875329

SMR004703418

SO 270

Sodium 2-(7-(3,3-dimethyl-1-(4-sulfonatobutyl)benz(e)indolin-2-ylidene)hepta-1,3,5-trien-1-yl)-3,3-dimethyl-1-(4-sulfonatobutyl)benz[e]indolinium

sodium 2-[(1E,3E,5E)-7-[(2Z)-1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-2-ylidene]hepta-1,3,5-trien-1-yl]-1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium

sodium 4-(2-((1E,3E,5E,7E)-7-(1,1-dimethyl-3-(4-sulfonatobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene)hepta-1,3,5-trien-1-yl)-1,1-dimethyl-1H-benzo[e]indol-3-ium-3-yl)b

sodium 4-(2-((1E,3E,5E,7E)-7-(1,1-dimethyl-3-(4-sulfonatobutyl)-1H-benzo[e]indol-2(3H)-ylidene)hepta-1,3,5-trienyl)-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate

sodium 4-(2-{7-[1,1-dimethyl-3-(4-sulfonatobutyl)-1H-benzo[e]indolium-2-yl]hepta-2,4,6-trien-1-ylidene}-1,1-dimethyl-1,2-dihydro-3H-benzo[e]indol-3-yl)butane-1-sulfonate

sodium 4-[(2E)-2-[(2E,4E,6E)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)-2-benzo[e]indol-3-iumyl]hepta-2,4,6-trienylidene]-1,1-dimethyl-3-benzo[e]indolyl]-1-butanesulfonate

sodium 4-[(2E)-2-[(2E,4E,6E)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethyl-benzo[e]indol-3-yl]butane-1-sulfonate

sodium 4-[(2E)-2-[(2Z,4Z,6Z)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethylbenzo[e]indol-3-yl]butane-1-sulfonate

sodium 4-[(2E)-2-{(2Z,4Z,6Z)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)-1H-benzo[e]indolium-2-yl]hepta-2,4,6-trien-1-ylidene}-1,1-dimethyl-1,2-dihydro-3H-benzo[e]indol-3-yl]butane-1-sulfonate

sodium 4-[(2Z)-2-[(2E,4E,6E)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethylbenzo[e]indol-3-yl]butane-1-sulfonate

sodium 4-[2-[(1E,3E,5E,7Z)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-2-ylidene]hepta-1,3,5-trienyl]-1,1-dimethylbenzo[e]indol-3-ium-3-yl]butane-1-sulfonate

sodium 4-[2-[7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethylbenzo[e]indol-3-yl]butane-1-sulfonate

ST24047406

Sucrose, crude (cane sugar)

Tox21_112674

Ujoviridin

UNII-IX6J1063HV

utane-1-sulfonate

Wofaverdin

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
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes
Akorn	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Akorn	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-004	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for indocyanine green

Country	Patent Number	Estimated Expiration
Russian Federation	2506896
Canada	2339214
Denmark	2910185
South Korea	101759850
Portugal	1143852
World Intellectual Property Organization (WIPO)	2009127972
Germany	60036781