SPY AGENT GREEN KIT Drug Patent Profile

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Which patents cover Spy Agent Green Kit, and what generic alternatives are available?

Spy Agent Green Kit is a drug marketed by Novadaq Tech and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in eleven countries.

The generic ingredient in SPY AGENT GREEN KIT is indocyanine green. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Spy Agent Green Kit

A generic version of SPY AGENT GREEN KIT was approved as indocyanine green by RENEW PHARMS on November 21^st, 2007.

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Summary for SPY AGENT GREEN KIT

International Patents:	55
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPY AGENT GREEN KIT
DailyMed Link:	SPY AGENT GREEN KIT at DailyMed

Drug patent expirations by year for SPY AGENT GREEN KIT

Paragraph IV (Patent) Challenges for SPY AGENT GREEN KIT

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 SPY AGENT GREEN KIT

SPY AGENT GREEN KIT is protected by eight US patents and one FDA Regulatory Exclusivity.

Patents protecting SPY AGENT GREEN KIT

Quantification of absolute blood flow in tissue using fluorescence-mediated photoplethysmography
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Patented Use: MEASURING TIME-VARYING CHANGE IN BLOOD IN A TISSUE VOLUME USING MODIFIED BEER-LAMBERT LAW IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY

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Method and apparatus for vasculature visualization with applications in neurosurgery and neurology
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Patented Use: VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF VESSEL WITH ARTERIOVENOUS MALFORMATION IN VASCULAR,GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY

Method for evaluating blush in myocardial tissue
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Patented Use: VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION IN SURGICAL FLAPS IN VASCULAR,GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY

Real time imaging during solid organ transplant
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Patented Use: VISUALIZATION OF EXTRAHEPATIC BILIARY DUCT ATTACHED TO TRANSPLANTED ORGAN IN PATIENTS 12 YEARS AND OLDER

Real time imaging during solid organ transplant
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Patented Use: VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF TRANSPLANTED ORGAN OR ATTACHED VESSEL IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY

Real time imaging during solid organ transplant
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Patented Use: VISUALIZATION OF VESSELS, BLOOD FLOW AND TISSUE PERFUSION OF DONOR ORGAN OR ATTACHED VESSEL IN VASCULAR, GASTROINTESTINAL, ORGAN TRANSPLANT, AND PLASTIC, MICRO- AND RECONSTRUCTIVE, INCLUDING MINIMALLY INVASIVE, SURGERY

FDA Regulatory Exclusivity protecting SPY AGENT GREEN KIT

FOR FLUORESCENCE IMAGING OF LYMPH NODES AND DELINEATION OF LYMPHATIC VESSELS DURINGLYMPHATIC MAPPING IN ADULTS WITH BREAST CANCER FOR WHICH THIS PROCEDURE IS A COMPONENT OF INTRAOPERATIVEMANAGEMENT
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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
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	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
>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 SPY AGENT GREEN KIT

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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 SPY AGENT GREEN KIT

See the table below for patents covering SPY AGENT GREEN KIT around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	101759850		⤷ Sign Up
Japan	2017534361		⤷ Sign Up
Canada	3011310	PROCEDE D'EVALUATION D'UNE OPACIFICATION D'UN TISSU MYOCARDIQUE (METHOD FOR EVALUATING BLUSH IN MYOCARDIAL TISSUE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration