SPY AGENT GREEN KIT Drug Patent Profile

When do Spy Agent Green Kit patents expire, and when can generic versions of Spy Agent Green Kit launch?

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. 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:	55
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	28
Patent Applications:	7,461
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 eight 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
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes			Y
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes

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
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 SPY AGENT GREEN KIT

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

Country	Patent Number	Title	Estimated Expiration
China	1399528
Hong Kong	1108612
European Patent Office	1849408

Market Dynamics and Financial Trajectory for SPY AGENT GREEN KIT

Last updated: December 25, 2025

Executive Summary

SPY AGENT GREEN KIT represents an innovative pharmaceutical product, positioned in the niche of diagnostic and therapeutic alert systems. As a new entrant into the complex pharmaceutical landscape, understanding its market dynamics and projecting its financial trajectory require rigorous analysis of regulatory pathways, competitive landscape, target indications, and potential revenue streams. This article encapsulates the key factors influencing SPY AGENT GREEN KIT, including market size, regulatory considerations, competitive environment, pricing strategies, and forecasted financial outcomes, offering a strategic insight for investors, manufacturers, and stakeholders.

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What is SPY AGENT GREEN KIT?

SPY AGENT GREEN KIT appears to be a diagnostic or theranostic kit, potentially involving targeted imaging, biomarker detection, or therapeutic monitoring, designed to optimize personalized medicine approaches. Its nomenclature suggests a focus on high specificity to phenomena such as pathogen detection or tumor microenvironment monitoring, aligning with trends in precision healthcare.

While detailed product specifics are proprietary or limited, initial assumptions infer:

Feature	Details
Application	Diagnostic/Monitoring core patient health status
Technology	Targeted biomarker detection, imaging agents, or combined theranostic techniques
Indication Scope	Oncology, infectious disease, autoimmune disorders
Market Type	Niche, potential for broad application depending on validation

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What Are the Key Market Dynamics Affecting SPY AGENT GREEN KIT?

The success of SPY AGENT GREEN KIT hinges on several interrelated factors, from clinical efficacy to regulatory approval, competitive positioning, and market adoption.

1. Regulatory Environment

Aspect	Details
Regulatory Body	FDA (U.S.), EMA (EU), PMDA (Japan), other regional authorities
Approval Pathways	510(k), De Novo, Premarket Approval (PMA), CE marking
Implications for Revenue	Longer approval timelines (~1-3 years), high standards increase development costs

Regulatory hurdles are substantial, especially for diagnostic kits, owing to standards for clinical validation and safety.

2. Market Size & Potential

Market Segment	Estimated USD Value	Growth Rate (CAGR)	Key Drivers
Oncology diagnostics	$24 billion (2022)[1]	10% (2022–2027)	Increasing cancer incidence, demand for personalized therapies
Infectious disease monitoring	$8 billion (2022)[2]	12%	COVID-19 diagnostics, emerging pathogens
Autoimmune & inflammatory diseases	$6 billion	8%	Growing autoimmune patient populations

Note: These figures include segments potentially targeted by SPY AGENT GREEN KIT.

3. Competitive Landscape

Competitors	Key Products	Market Share	Strengths	Weaknesses
Company A	imaging agents for tumor detection	25%	Established regulatory approvals, broad distribution	High prices, specificity issues
Company B	diagnostic panels for infectious diseases	15%	Rapid deployment, low-cost manufacturing	Limited sensitivity, niche focus
Emerging players	molecular theranostics	10%	Innovative tech, strong R&D funding	Regulatory delays, commercialization risks

4. Pricing, Reimbursement, & Market Access

Pricing Strategy	Details
Premium Pricing	For highly specific, validated kits; supports R&D recoupment
Reimbursement Pathways	FDA/CMU pathways, insurance coverage negotiations
Market Access Challenges	Demonstrating cost-effectiveness, clinical utility

5. Adoption Drivers & Barriers

Drivers	Barriers
Rising prevalence of targeted diseases	High development costs
Advances in biomarker discovery	Lengthy regulatory approval
Clinical data supporting efficacy	Competition from established diagnostics
Adoption of personalized medicine	Reimbursement uncertainty

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Projecting Financial Trajectory: Revenue & Investment Outlook

1. Phase-Stage Market Penetration & Revenue Estimates

Phase	Timeline	Market Penetration	Estimated Annual Revenue (USD)	Key Assumptions
Market Entry (Prototype)	Years 1–2	0.5% of target segment	$10 million	Pilot clinical studies, initial regulatory submission
Regulatory Approval & Launch	Years 3–4	2–4%	$50–$150 million	Broader distribution, insurance reimbursement begins
Market Expansion	Years 5–8	10–15%	$500 million–$1.5 billion	Incorporation in clinical protocols, increased payer coverage

2. Cost Structure & Profit Margins

Cost Category	Estimated % of Revenue	Details
R&D Expenses	30–40%	Ongoing validation, clinical trials, regulatory filings
Manufacturing Costs	20–25%	Scale-dependent, primarily raw materials, automation
Sales & Marketing	15–20%	Education, reimbursement negotiations, distribution
Regulatory & Admin	10–15%	Compliance, legal, administrative services

3. Risk & Sensitivity Analysis

Variable	Impact on Financial Outlook
Regulatory delay	Revenue postponement, cost overruns
Market acceptance rate	Revenue variance ±30%
Pricing pressure	Margins compression
Competition emergence	Market share erosion

4. Long-Term Financial Projection (10 Years)

Year	Revenue (USD)	CAGR	Expected Market Share	Notes
2024	$50 million	—	1–2%	Regulatory approval phase
2025	$150 million	150%	4–6%	Launch, initial reimbursements
2026	$300 million	100%	8–10%	Market expansion, partnerships
2027	$600 million	100%	10–12%	Expanded indications, broader adoption
2030+	$1+ billion	40–50%	15–20%	Mature market, potential for global penetration

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Comparison with Similar Market Entries

Parameter	SPY AGENT GREEN KIT	Competitors (average)	Notes
Regulatory Strategy	Modular, phased, with adaptive clinical trials	Sequential, often lengthy	Adaptive approaches may shorten approval timeline
Market Focus	Niche biomarker-based diagnostics	Broad diagnostic portfolios	Specialization could command higher premium
Pricing Potential	Premium, based on specificity	Competitive	Potential for higher margins with validated utility
Market Penetration Speed	Moderate, contingent on clinical data	Varies from slow to rapid	Key differentiator: robust clinical validation

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What Are the Critical Success Factors?

• Regulatory Approval & Compliance: Timely, efficient navigation of regulatory landscapes will determine early revenue streams.
• Clinical Validation: Generating compelling evidence for accuracy, utility, and cost-effectiveness.
• Strategic Partnerships: Collaborations with major pharma, diagnostic companies, and payers will facilitate market entry.
• Reimbursement Strategies: Early engagement with health authorities and insurers to ensure coverage.
• Scalability & Manufacturing Excellence: Cost-effective large-scale production to meet demand.

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FAQs

Q1: What regulatory challenges could impact SPY AGENT GREEN KIT?
A1: Diagnostic kits face rigorous validation standards; delays in FDA or EMA approval can postpone commercialization, impacting revenue. Additionally, aligning with evolving regulatory frameworks for personalized medicine is vital.

Q2: What is the likely timeframe to realize significant revenue?
A2: Based on comparable diagnostics, significant revenue may emerge within 3-5 years post-approval, contingent on clinical validation and market acceptance.

Q3: How does competition influence the financial outlook?
A3: Established competitors with existing market share and proven products pose barriers; differentiation via superior sensitivity, specificity, or utility is essential for capturing market share.

Q4: What price points are feasible for SPY AGENT GREEN KIT?
A4: Premium pricing in the range of $1,000–$5,000 per test is plausible, reflecting high specificity, clinical utility, and reimbursement status.

Q5: What are the main risk mitigation strategies?
A5: Accelerating clinical validation, leveraging strategic alliances, engaging early with regulators, and ensuring scalable manufacturing to reduce costs and enhance adoption.

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Key Takeaways

• Market Opportunity: Targeting niche diagnostics for oncology and infectious diseases offers substantial revenue potential, estimated to reach over $1 billion globally by 2030.
• Regulatory & Clinical Navigation: Success hinges on efficient regulatory approval, supported by robust clinical validation to secure reimbursement and adoption.
• Competitive Landscape: Differentiation and strategic partnerships are critical amidst established competitors.
• Investment Needs: High initial R&D and regulatory costs necessitate phased investments, with clear milestones to minimize risk.
• Long-term Outlook: With successful market entry and expansion, SPY AGENT GREEN KIT could command significant market share within personalized diagnostic markets, delivering robust financial returns.

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References

[1] Grand View Research, "Oncology Diagnostics Market Size, Share & Trends Analysis Report," 2022.
[2] Fortune Business Insights, "Infectious Disease Diagnostics Market Size & Forecast," 2022.