SPY AGENT GREEN KIT Drug Patent Profile

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 five patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-six 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. Two 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.

Summary for SPY AGENT GREEN KIT

International Patents:	56
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	28
Patent Applications:	7,127
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPY AGENT GREEN KIT
DailyMed Link:	SPY AGENT GREEN KIT at DailyMed

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 six US patents and one FDA Regulatory Exclusivity.

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	8,647,605
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	8,406,860
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes	8,185,176

Expired US Patents for SPY AGENT GREEN KIT

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	6,915,154
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018	8,892,190
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018	7,881,777
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018	9,421,280

International Patents for SPY AGENT GREEN KIT

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

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)

SPY AGENT GREEN KIT Market Dynamics and Financial Trajectory: Sales Trends, Competitive Pressure, and Exclusivity/Litigation Overhang

Last updated: July 23, 2026

No market dynamics or financial trajectory can be produced for “SPY AGENT GREEN KIT” because the request does not provide verifiable identifiers linking the product to an approved drug, a specific NDA/BLA, an active ingredient, a dosage form, a manufacturer, a GUDID/NDC labeler, or a commercial geography. Without those identifiers, any sales, reimbursement, competitive, exclusivity, or litigation assessment would be fabricated.

Key takeaways

• The product cannot be mapped to a specific regulated drug approval or commercial label using the provided name alone.
• No defensible analysis of pricing, revenue, growth, payer adoption, or competitive entry risks is possible without a drug identity (NDA/BLA/NDC/labeler/active ingredient/manufacturer).

FAQs

1. What approval status does “SPY AGENT GREEN KIT” have with FDA (NDA/BLA)?
2. Is “SPY AGENT GREEN KIT” listed in the FDA Orange Book, and what patents are associated?
3. Which generic or biosimilar products could compete with “SPY AGENT GREEN KIT”?
4. What exclusivity timelines apply (3-year/5-year/7-year, pediatric, orphan, REMS)?
5. What litigation history exists (Paragraph IV, Hatch-Waxman settlements, TRO/PI actions)?

References (APA)
No sources cited because the product could not be verified to a specific approved drug entity based on the provided input.