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 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
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
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
European Patent Office	3278723
Brazil	PI0907272
Germany	60036781
World Intellectual Property Organization (WIPO)	2012038824
South Korea	20160040315

Market Dynamics and Financial Trajectory for SPY AGENT GREEN KIT

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by advances in biotechnology, regulatory changes, and shifting healthcare demands. Among emerging products, SPY AGENT GREEN KIT has attracted attention as an innovative diagnostic and therapeutic tool, potentially redefining practices in personalized medicine. This analysis explores the market dynamics influencing SPY AGENT GREEN KIT and forecasts its financial trajectory amid industry trends, competitive forces, regulatory frameworks, and healthcare innovations.

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Product Overview and Market Position

SPY AGENT GREEN KIT is positioned as a comprehensive diagnostic platform, combining proprietary green fluorescent agents with targeted molecular imaging. Its primary application lies in oncological surgeries and precision diagnostics, facilitating real-time tumor visualization. The device’s unique mechanism—leveraging fluorescence-guided surgery—enables surgeons to achieve cleaner margins, potentially reducing recurrence rates.

The product's appeal hinges on its ability to enhance surgical efficacy, improve patient outcomes, and reduce long-term healthcare costs. Currently, the kit is undergoing clinical validation phases in multiple jurisdictions, with regulatory submissions anticipated within the next 12 months.

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Market Dynamics

1. Growing Demand for Precision Medicine

The global shift toward personalized healthcare fuels demand for advanced diagnostic tools like SPY AGENT GREEN KIT. The increasing incidence of cancers, especially colorectal, breast, and lung cancers, accelerates need for effective intraoperative imaging solutions. According to the World Health Organization (WHO), cancer cases are projected to reach 28.4 million by 2040, a 47% increase from 2020, amplifying market opportunities for targeted surgical adjuncts.

2. Technological Advancements and Innovation

Innovation in molecular imaging, including fluorescent dyes and real-time visualization platforms, supports a conducive environment for SPY AGENT GREEN KIT's adoption. Integration with minimally invasive and robotic surgeries enhances its utility, aligning with the trend toward less invasive, high-precision interventions.

3. Regulatory and Reimbursement Landscape

Regulatory pathways in FDA, EMA, and other jurisdictions shape product commercialization trajectories. SPY AGENT GREEN KIT's clearance hinges on demonstrating safety, specificity, and clinical efficacy. Reimbursement policies further influence market penetration; positive reimbursement decisions can accelerate adoption, whereas uncertainty or delays may hinder growth.

4. Competitive Landscape

The market features key players such as FluOptica, Novadaq (taken over by Stryker), and Medtronic, all offering fluorescence-guided surgical systems. SPY AGENT GREEN KIT’s differentiation lies in its proprietary formulation and potential for enhanced imaging clarity. Competitive intensity prompts ongoing innovation and strategic collaborations, which can influence market share dynamics.

5. Healthcare Infrastructure and Adoption Barriers

Widespread adoption depends on surgical infrastructure, clinician training, and institutional willingness to integrate new technologies. Limited awareness, high upfront costs, and regulatory bottlenecks pose barriers, especially in emerging markets.

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Financial Trajectory Projections

1. Revenue Forecasting

Based on industry analyses, the global fluorescence-guided surgery market is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 10-12% from 2023 to 2030, reaching estimated values of USD 2.5 billion. SPY AGENT GREEN KIT, expected to secure regulatory approval by 2024, could capture 3-5% of this market within five years post-launch, translating to potential revenues of USD 75-125 million annually by 2028.

2. Market Penetration and Adoption Rate

Early adoption will likely be concentrated in developed regions like North America and Europe due to better healthcare infrastructure. Gradual expansion into Asia-Pacific, Latin America, and Africa hinges on regulatory pathways, local partnerships, and affordability strategies. An initial adoption rate of 10-15% among targeted surgical centers is plausible within the first three years post-market entry, increasing as evidence of clinical benefits accumulates.

3. Cost Analysis and Pricing Strategy

Pricing strategies should balance recouping R&D investments and market competitiveness. A price point of USD 2,000-5,000 per kit, aligned with current fluorescence imaging adjuncts, would likely position the product effectively. High-volume sales could enable economies of scale, reducing per-unit costs.

4. Investment and R&D Outlook

Future investments in clinical trials, post-market surveillance, and technological enhancement are critical. Anticipated R&D expenditure of USD 30-50 million over the next five years can solidify product position and foster continuous innovation.

5. Potential Revenue Levers

• Clinical endorsements and published outcomes will enhance credibility and accelerate adoption.
• Strategic collaborations with healthcare providers and device manufacturers can expand reach.
• Expansion into new indications (e.g., vascular surgeries, neurosurgery) offers additional growth pathways.

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Industry and Regulatory Risks

• Regulatory uncertainties may delay market entry or limit geographic scope.
• Intense competition demands relentless innovation and differentiation.
• Market acceptance challenges owing to high procurement costs or resistance from established surgical systems.
• Technological obsolescence as emerging imaging modalities (e.g., advanced POS systems, AI-driven diagnostics) evolve.

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Strategic Outlook

Achieving a sustainable financial trajectory requires proactive planning:

• Regulatory Strategy: Engage early with agencies for smooth approval processes.
• Clinical Validation: Conduct robust trials demonstrating efficacy and safety to build confidence.
• Market Education: Implement targeted education campaigns for surgeons and healthcare administrators.
• Partnership Development: Establish collaborations with hospital systems, device manufacturers, and biotech firms.
• Cost Optimization: Leverage manufacturing efficiencies for competitive pricing.

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Key Takeaways

• Market Opportunity: The global fluorescence-guided surgery market is poised for substantial growth, driven by rising cancer incidence and advances in intraoperative imaging technology.
• Growth Drivers: Technological innovation, expanding clinical evidence, and healthcare infrastructure improvements are critical.
• Financial Outlook: With strategic positioning, SPY AGENT GREEN KIT could generate USD 75-125 million annually within five years of market entry.
• Risks & Challenges: Regulatory delays, competitive pressures, high costs, and adoption barriers may impact financial performance.
• Strategic Recommendations: Early engagement with regulators, clinical validation, strategic partnerships, and cost management are essential for sustainable growth.

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FAQs

Q1: What factors will most significantly influence SPY AGENT GREEN KIT’s market penetration?
Regulatory approval speed, clinical trial results, reimbursement policies, clinician training, and competitive positioning will determine how quickly and extensively the product penetrates target markets.

Q2: How does SPY AGENT GREEN KIT differentiate from existing fluorescence-guided surgical tools?
Its proprietary green fluorescent agents offer superior tissue contrast and stability, potentially enabling more precise tumor visualization compared to existing dyes.

Q3: What are the primary regulatory hurdles for SPY AGENT GREEN KIT?
Regulatory agencies require comprehensive safety and efficacy data, with additional validation needed for different indications and geographic markets.

Q4: What impact will emerging technologies like AI and robotics have on SPY AGENT GREEN KIT’s adoption?
Integration with AI and robotic platforms can amplify its utility, making it more attractive to high-end surgical centers and accelerating adoption.

Q5: When can investors expect the first revenue streams from SPY AGENT GREEN KIT?
Assuming successful clinical validation and regulatory approval by 2024, initial revenues could emerge within 12-24 months post-launch, contingent on market acceptance and reimbursement policies.

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References

[1] World Health Organization, Global Cancer Statistics, 2020.
[2] MarketWatch, Fluorescence-Guided Surgery Market Analysis, 2022.
[3] FDA Guidance Documents, 2021.
[4] IBISWorld, Surgical Imaging Equipment Industry Report, 2022.
[5] Frost & Sullivan, Emerging Trends in Medical Imaging, 2023.