Indocyanine green - Generic Drug Details

What are the generic drug sources for indocyanine green and what is the scope of freedom to operate?

Indocyanine green is the generic ingredient in three branded drugs marketed by Renew Pharms and Novadaq Tech, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indocyanine green has fifty-five patent family members in eleven countries.

There are three drug master file entries for indocyanine green. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for indocyanine green

International Patents:	55
US Patents:	6
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	217
Patent Applications:	6,988
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for indocyanine green
What excipients (inactive ingredients) are in indocyanine green?	indocyanine green excipients list
DailyMed Link:	indocyanine green at DailyMed

Recent Clinical Trials for indocyanine green

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	Phase 4
Stryker Nordic	Phase 4
Northwestern University	Phase 4

See all indocyanine green clinical trials

Generic filers with tentative approvals for INDOCYANINE GREEN

Applicant	Application No.	Strength	Dosage Form
		40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION
		10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION
		50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for indocyanine green

Coloring Agents

Anatomical Therapeutic Chemical (ATC) Classes for indocyanine green

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

Paragraph IV (Patent) Challenges for INDOCYANINE GREEN

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 indocyanine green

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
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Novadaq Tech	SPY AGENT GREEN KIT	indocyanine green	POWDER;INTRAVENOUS, INTERSTITIAL	211580-001	Nov 21, 2018		RX	Yes	Yes	11,712,320		Y
Renew Pharms	INDOCYANINE GREEN	indocyanine green	INJECTABLE;INJECTION	040811-001	Nov 21, 2007		RX	No	Yes
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for indocyanine green

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

International Patents for indocyanine green

Country	Patent Number	Title	Estimated Expiration
South Korea	20170066600
World Intellectual Property Organization (WIPO)	2009127972
South Korea	20100136540	LOCATING AND ANALYZING PERFORATOR FLAPS FOR PLASTIC AND RECONSTRUCTIVE SURGERY
Russian Federation	2506896	ОПРЕДЕЛЕНИЕ МЕСТОПОЛОЖЕНИЯ И АНАЛИЗ ПЕРФОРИРОВАННЫХ ЛОСКУТОВ ДЛЯ ПЛАСТИЧЕСКОЙ И ВОССТАНОВИТЕЛЬНОЙ ХИРУРГИИ (DETERMINATION OF LOCATION AND ANALYSIS OF PERFORATED FLAPS FOR PLASTIC AND REHABILITATIVE SURGERY)
South Korea	102012880

Indocyanine green Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Indocyanine Green

Market Overview

The Indocyanine Green (ICG) market is experiencing significant growth, driven by its versatile applications in medical imaging, particularly in ophthalmology, cardiology, and neurosurgery. Here are the key dynamics and financial projections for this market.

Market Size and Growth

The global ICG market is projected to grow substantially over the next few years. As of 2024, the market size is estimated to be around $52 million, and it is anticipated to reach $68 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.8%[1][4].

However, another forecast suggests a slightly higher growth rate, with the market estimated to reach $85.6 million by 2030, at a CAGR of 7.89%[4].

Key Drivers

Expanding Use in Fluorescence-Guided Surgery

The increasing use of ICG in fluorescence-guided surgery is a significant driver. Surgeons rely on ICG to identify tumors, assess blood flow, and ensure precise surgical interventions, particularly in oncology and cardiovascular procedures[1].

Rising Adoption in Ophthalmology

ICG is widely used in ophthalmology for retinal angiography to diagnose and monitor conditions such as macular degeneration and diabetic retinopathy. This trend reflects the growing focus on early diagnosis and management of vision-related disorders[1].

Integration with Advanced Imaging Technologies

The integration of ICG into hybrid imaging systems is transforming diagnostic practices. These systems combine multiple imaging modalities, offering enhanced visualization and comprehensive diagnostic insights[1].

Research and Development

The growing focus on research and development is introducing new applications for ICG, including regenerative medicine and tissue engineering. This innovation highlights the market’s potential for growth in cutting-edge medical fields[1].

Applications and Segments

Ophthalmology

The ophthalmology segment is expected to expand significantly, retaining its position throughout the forecast period. ICG is crucial for diagnosing and monitoring various eye conditions[3].

Neurosurgery and Cardiovascular Procedures

ICG is also widely used in neurosurgery and cardiovascular procedures. Its application in sentinel lymph node mapping for various cancers and in the removal of deep-seated arterio-venous malformations is notable[2].

Liver Diseases and Other Applications

ICG is used in diagnosing and managing liver diseases, as well as in other medical conditions such as Behcet's disease, choroidal melanoma, and critical limb ischemia[2].

Regional Analysis

North America and Europe

These regions dominate the ICG market due to their advanced healthcare infrastructure and strong focus on research and development. However, emerging economies in Asia-Pacific and Latin America are also showing promising growth[4].

Competitive Landscape

The market is competitive, with key players such as Diagnostic Green, SERB, Daiichi Sankyo Company, Santen Pharmaceutical Co., Ltd., Aurolab, Yichuang, and Eisai. These companies are focusing on strategic alliances, mergers, and expanding their regional footprints to maintain a competitive edge[1][4].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the ICG market, leading to a decline in demand due to the deferral or cancellation of elective medical procedures. However, as the pandemic receded, the market saw a recovery with medical facilities resuming elective procedures and governments emphasizing medical research and healthcare framework enhancements[4].

Financial Trajectory

Revenue Forecast

The market is expected to grow from $52 million in 2024 to $68 million by 2030, with a CAGR of 4.8%[1]. Alternatively, another forecast projects the market to reach $85.6 million by 2030, with a CAGR of 7.89%[4].

Segment Analysis

The Pharma Grade segment accounted for a noticeable share of the global ICG market in 2023 and is projected to experience significant growth in the near future. The ophthalmology segment is also expected to expand at a significant CAGR throughout the forecast period[3].

Technological Trends

The ICG market is witnessing innovation with the integration of ICG into advanced imaging technologies, such as hybrid imaging systems. This trend underscores the importance of innovation in improving patient outcomes[1].

Market Recovery and Future Outlook

As the healthcare sector recovers from the pandemic, the ICG market is expected to continue its growth trajectory. Companies are optimizing their supply chains, pivoting towards local sourcing, and amplifying their digital outreach to meet the evolving needs of healthcare professionals[4].

Key Takeaways

• The global ICG market is projected to grow from $52 million in 2024 to $68 million by 2030, with a CAGR of 4.8%.
• The market is driven by expanding use in fluorescence-guided surgery, rising adoption in ophthalmology, and integration with advanced imaging technologies.
• Key applications include ophthalmology, neurosurgery, and cardiovascular procedures.
• North America and Europe dominate the market, but emerging economies are showing promising growth.
• The market recovered from the COVID-19 pandemic and is expected to continue growing as healthcare sectors enhance their infrastructure and research.

FAQs

1. What is the projected market size of Indocyanine Green by 2030?

The market is projected to reach $68 million by 2030, with a CAGR of 4.8%[1].

2. What are the primary applications of Indocyanine Green?

Primary applications include ophthalmology, neurosurgery, cardiovascular procedures, and liver diseases[1][2].

3. How did the COVID-19 pandemic affect the Indocyanine Green market?

The pandemic led to a decline in demand due to the deferral or cancellation of elective medical procedures, but the market has since recovered as healthcare facilities resumed these procedures[4].

4. Which regions dominate the Indocyanine Green market?

North America and Europe dominate the market, but emerging economies in Asia-Pacific and Latin America are also growing[4].

5. What are the key trends reshaping the Indocyanine Green market?

Key trends include the integration of ICG into advanced imaging technologies, rising adoption in ophthalmology, and expanding use in fluorescence-guided surgery[1][4].

Cited Sources:

1. Global Indocyanine Green Market Insights, Forecast to 2030 - Valuates Reports
2. Indocyanine Green Angiography - Medical Clinical Policy Bulletins - Aetna
3. Indocyanine Green Market Report 2024 (Global Edition) - Cognitive Market Research
4. Indocyanine Green Market - Global Growth Insights - Global Growth Insights