INDOCYANINE GREEN - Generic Drug Details

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

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

Indocyanine green has fifty-five patent family members in eleven countries.

There are three drug master file entries for indocyanine green. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for INDOCYANINE GREEN

International Patents:	55
US Patents:	6
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	217
Patent Applications:	6,982
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
University of Alabama at Birmingham	Phase 4
Stryker Nordic	Phase 4
Northwestern University	Phase 4

See all INDOCYANINE GREEN clinical trials

Generic filers with tentative approvals for INDOCYANINE GREEN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	25MG/VIAL	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION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

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Glossary

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

Expired US Patents for INDOCYANINE GREEN

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

International Patents for INDOCYANINE GREEN

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Country	Patent Number	Title	Estimated Expiration
Japan	2017534361		⤷ Sign Up
Russian Federation	2011111078	ОПРЕДЕЛЕНИЕ МЕСТОПОЛОЖЕНИЯ И АНАЛИЗ ЛОСКУТОВ ПЕРФОРАТОРА ДЛЯ ПЛАСТИЧЕСКОЙ И ВОССТАНОВИТЕЛЬНОЙ ХИРУРГИИ	⤷ Sign Up
Canada	3011310	PROCEDE D'EVALUATION D'UNE OPACIFICATION D'UN TISSU MYOCARDIQUE (METHOD FOR EVALUATING BLUSH IN MYOCARDIAL TISSUE)	⤷ Sign Up
Canada	2811847	LOCALISATION ET ANALYSE DE LAMBEAUX PERFORANTS POUR UNE CHIRURGIE PLASTIQUE ET RECONSTRUCTIVE (LOCATING AND ANALYZING PERFORATOR FLAPS FOR PLASTIC AND RECONSTRUCTIVE SURGERY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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