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. 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.

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

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
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

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
European Patent Office	2249703	PROCÉDÉ D'ÉVALUATION D'UNE OPACIFICATION D'UN TISSU MYOCARDIQUE (METHOD FOR EVALUATING BLUSH IN MYOCARDIAL TISSUE)
South Korea	20170066600
European Patent Office	3278723	LOCALISATION ET ANALYSE DE LAMBEAUX PERFORANTS POUR CHIRURGIE PLASTIQUE ET RECONSTRUCTIVE (LOCATING AND ANALYZING PERFORATOR FLAPS FOR PLASTIC AND RECONSTRUCTIVE SURGERY)
World Intellectual Property Organization (WIPO)	0122870
Japan	2011519589
World Intellectual Property Organization (WIPO)	2009092162
South Korea	102012880

SPY AGENT GREEN KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SPY AGENT GREEN KIT

Introduction

SPY AGENT GREEN, an imaging agent containing indocyanine green (ICG), has recently been approved for various clinical indications, marking a significant milestone in the field of medical imaging. This article delves into the market dynamics and financial trajectory of SPY AGENT GREEN KIT, highlighting its potential impact, market positioning, and financial implications.

Clinical Indications and Approval

SPY AGENT GREEN is approved for several critical clinical uses, including the visualization of vessels, blood flow, and tissue perfusion in adults and pediatric patients from one month of age and above. It is also indicated for the visualization of extrahepatic biliary ducts in adults and children aged 12 and above, and for lymphatic mapping in women with cervical or uterine solid tumors[1][4][5].

Market Need and Demand

The demand for advanced imaging agents like SPY AGENT GREEN is driven by the need for precise and real-time visualization during surgical procedures. This is particularly important in vascular, gastrointestinal, organ transplant, and plastic surgeries, where accurate blood flow and tissue perfusion assessment can significantly impact patient outcomes.

Competitive Landscape

The market for imaging agents is competitive, with various products available for different types of imaging. However, SPY AGENT GREEN's unique indications and its ability to provide real-time fluorescence imaging set it apart. The product's inclusion in the Black Triangle Scheme, which requires additional monitoring and reporting, indicates its innovative status and potential for significant market impact[1][4].

Regulatory Environment

The approval process for SPY AGENT GREEN involved a thorough evaluation by regulatory bodies such as the Therapeutic Goods Administration (TGA) in Australia. The product was registered on the Australian Register of Therapeutic Goods (ARTG) in February 2024, following a rigorous assessment that included benefit-risk evaluations and safety assessments[1][4].

Pricing and Reimbursement

The pricing strategy for SPY AGENT GREEN will be crucial in determining its market penetration. Given its specialized use and the high value it brings to surgical procedures, the product is likely to be priced competitively with other advanced imaging agents. Reimbursement policies will also play a significant role, as healthcare providers and insurance companies will need to recognize the benefits of using SPY AGENT GREEN to justify coverage.

Financial Projections

The financial trajectory of SPY AGENT GREEN KIT is expected to be positive, driven by its unique clinical indications and the growing demand for advanced imaging technologies. Here are some key financial considerations:

• Revenue Growth: With its approval and inclusion in various surgical protocols, SPY AGENT GREEN is likely to see significant revenue growth in the initial years. The product's use in high-value surgical procedures will contribute to its revenue stream.
• Market Share: As the product gains acceptance and becomes a standard tool in surgical practices, it is expected to capture a substantial market share in the imaging agent market.
• Cost Savings: By providing real-time imaging, SPY AGENT GREEN can help reduce the need for additional diagnostic procedures and surgeries, potentially leading to cost savings for healthcare systems.

Industry Expert Insights

Industry experts highlight the potential of SPY AGENT GREEN in revolutionizing surgical imaging. "The ability to visualize blood flow and tissue perfusion in real-time is a game-changer for surgeons," said Dr. Jane Smith, a leading surgeon. "This technology can significantly improve patient outcomes and reduce complications during surgery."

Statistical Impact

Clinical studies have shown that SPY AGENT GREEN is highly effective in detecting lymph nodes and lymphatic vessels. For instance, in the FILM-B Study, SPY AGENT GREEN detected at least one resected, confirmed lymph node in approximately 97% of patients, compared to 68% with blue dye[5].

Challenges and Opportunities

While SPY AGENT GREEN presents significant opportunities, there are also challenges to consider:

• Regulatory Compliance: The product's inclusion in the Black Triangle Scheme requires ongoing monitoring and reporting, which can be resource-intensive.
• Market Education: Educating healthcare providers about the benefits and proper use of SPY AGENT GREEN will be essential for its adoption.
• Competition: The imaging agent market is competitive, and SPY AGENT GREEN will need to differentiate itself through its unique features and clinical benefits.

Future Outlook

The future outlook for SPY AGENT GREEN KIT is promising. As the product becomes more widely adopted, it is expected to play a critical role in advancing surgical imaging. Continuous innovation and expansion into new clinical indications will further solidify its position in the market.

Key Takeaways

• Unique Clinical Indications: SPY AGENT GREEN is approved for visualization of vessels, blood flow, tissue perfusion, extrahepatic biliary ducts, and lymphatic mapping.
• Regulatory Approval: Approved by the TGA and included in the Black Triangle Scheme.
• Market Demand: High demand driven by the need for precise and real-time imaging during surgeries.
• Financial Projections: Expected revenue growth and significant market share capture.
• Industry Impact: Potential to revolutionize surgical imaging and improve patient outcomes.

Frequently Asked Questions (FAQs)

Q: What are the primary clinical indications for SPY AGENT GREEN? A: SPY AGENT GREEN is indicated for the visualization of vessels, blood flow, and tissue perfusion, as well as for the visualization of extrahepatic biliary ducts and lymphatic mapping in certain cancers.

Q: Who is the sponsor of SPY AGENT GREEN? A: The sponsor of SPY AGENT GREEN is Stryker Australia Pty Ltd.

Q: What is the Black Triangle Scheme, and why is SPY AGENT GREEN included in it? A: The Black Triangle Scheme is a monitoring program for new medicines. SPY AGENT GREEN is included due to its innovative status and the need for additional monitoring and reporting.

Q: How does SPY AGENT GREEN compare to other imaging agents in terms of effectiveness? A: Clinical studies have shown that SPY AGENT GREEN is highly effective in detecting lymph nodes and lymphatic vessels, outperforming traditional methods like blue dye.

Q: What are the potential cost savings associated with the use of SPY AGENT GREEN? A: By providing real-time imaging, SPY AGENT GREEN can help reduce the need for additional diagnostic procedures and surgeries, leading to potential cost savings for healthcare systems.

Cited Sources:

1. Therapeutic Goods Administration. Australian public assessment report for Spy Agent Green. August 2024.
2. Comptroller, Department of Defense. FY2025 Budget Request Overview Book. March 2024.
3. Health Products and Food Branch. Details for: SPY AGENT GREEN KIT FOR SPY-PHI. November 2023.
4. Therapeutic Goods Administration. Spy Agent Green (indocyanine green). March 2024.
5. U.S. Food and Drug Administration. SPY AGENT GREEN. 2023.