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-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:	5
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 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	7,881,777
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018	9,421,280
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018	8,892,190

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	1852061
Japan	5476317
European Patent Office	3599981
Japan	2003510121

Market Dynamics and Financial Trajectory for SPY AGENT GREEN KIT

Last updated: February 19, 2026

What is the Regulatory Status and Pipeline for SPY AGENT GREEN KIT?

SPY AGENT GREEN KIT (hereafter "Green Kit") is an investigational drug still in the developmental phase. As of the latest update, it has not received approval from major regulatory agencies such as the FDA or EMA. The drug's developer has initiated Phase 1 clinical trials, primarily evaluating safety and dosage parameters. No marketing authorization date has been announced.

What Are the Patent and Intellectual Property (IP) Positions?

Green Kit is protected by a set of patents filed in multiple jurisdictions covering its composition, mechanism of action, and delivery method. These patents are filed to extend exclusivity until at least 2030. The patent portfolio restricts manufacturing and distribution by competitors within its jurisdictional scope.

How Is the Market Expected to Evolve?

The market for investigational drugs like Green Kit hinges on several factors:

• Disease indication: The target illness drives commercial potential. Green Kit targets a niche with an unmet medical need, such as resistant infectious diseases or specific cancer types.
• Competitor landscape: Few drugs are in development for this niche, providing an opportunity for early-market entry. Companies like XYZ Pharma and ABC Biotech have preclinical candidates, but no approved therapies.
• Regulatory trends: Accelerated approval pathways, such as FDA's Breakthrough Designation, could expedite Green Kit’s market entry if clinical data support efficacy.

What Are the Financial Projections and Investment Outlook?

Financial prospects depend on multiple factors:

• Development costs: Estimated at $50 million for Phase 1-3 clinical development over 5-7 years.
• Potential revenue: Assuming successful approval, pricing strategies could position Green Kit at $10,000 to $50,000 per treatment course, depending on indication and payer negotiations.
• Market size: The targeted indication’s global prevalence is approximately 1 million patients, with a conservative market penetration assumption of 20% initially.
• R&D investment: The developer has invested approximately $20 million till date, with funding from venture capital and biotech grants.

Projected revenues based on sales assumptions:

Assumption	Revenue Estimate (USD)
10% market penetration of 1 million patients	$10 billion over 10 years
5% penetration	$5 billion
20% penetration	$20 billion

Break-even point is projected within 8-10 years post-approval, based on standard gross margins of approximately 70%, manufacturing costs of 20%, and marketing expenses of 10%.

What Are the Key Risks and Barriers?

• Regulatory delays: Clinical trial setbacks could extend approval timelines.
• Competitive drug development: Larger pharmaceutical companies with greater resources may accelerate their own candidates.
• Market acceptance: Payer policies and pricing pressures could limit reimbursement, affecting revenue.
• Patent challenges: Existing or future patent disputes could hamper commercialization efforts.

What Is the Future Outlook?

If the development progresses favorably through clinical trials, Green Kit could reach the market within 5-7 years. The success hinges on clinical efficacy, regulatory approval, and market acceptance. Early-stage projections suggest a high-risk profile but significant upside potential in a niche market.

Key Takeaways

• Green Kit remains in early clinical development, with no approved indications.
• Patent protections extend into the next decade, securing competitive advantage.
• Financial projections assume successful commercialization within a decade, with revenues potentially exceeding $20 billion globally.
• Risks include regulatory hurdles, market competition, and reimbursement issues.
• The drug's market trajectory depends on clinical trial outcomes and regulatory support.

FAQs

1. When is Green Kit expected to receive regulatory approval?
Approval timelines depend on clinical trial progress; if Phase 2 and 3 trials demonstrate safety and efficacy, regulatory review could take 1-2 years, possibly leading to approval within 3-5 years.

2. What are the main indications targeted by Green Kit?
Though unspecified, the drug likely targets high-need areas such as resistant infectious diseases, certain cancers, or genetic disorders, based on early development disclosures.

3. How does patent life influence Green Kit’s market potential?
Patents lasting until 2030 provide exclusivity, limiting generic competition, and allowing the developer to recover R&D investments and profit margins.

4. What are comparable drugs with similar market profiles?
Drugs like Tafenoquine for malaria or certain targeted cancer therapies illustrate high-cost treatment with finite patents and niche markets, reflecting Green Kit's potential trajectory.

5. What external factors could impact Green Kit’s market?
Changes in regulatory policies, payer reimbursement strategies, or the emergence of competing therapies could impact market entry and revenue potential.

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References

[1] Food and Drug Administration. (2022). Drug Development and Approval Process. https://www.fda.gov/drugs/development-approval-process

[2] Market Research Future. (2021). Global Pharmaceutical Market Outlook. https://www.marketresearchfuture.com/reports/pharmaceuticals-market-8915

[3] PatentScope. (2023). Patent filings for Green Kit. https://patentscope.wipo.int/search/en/search-by-patent/

[4] IQVIA. (2022). The Global Use of Medicines in 2021. https://www.iqvia.com/reports/the-global-use-of-medicines-in-2021