Indocyanine green - Generic Drug Details

What are the generic drug sources for indocyanine green and what is the scope of patent protection?

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:	6,563
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		40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION
		10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION
		50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION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
Renew Pharms	INDOCYANINE GREEN	indocyanine green	INJECTABLE;INJECTION	040811-001	Nov 21, 2007	AP	RX	No	Yes

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
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 indocyanine green

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009092162
South Korea	102012880
Japan	2016135253	組織灌流を評価するための方法及びシステム (METHOD AND SYSTEM FOR EVALUATING TISSUE PERFUSION)
Canada	2963450	QUANTIFICATION DE CIRCULATION SANGUINE ABSOLUE DANS UN TISSU A L'AIDE DE PHOTOPLETHYSMOGRAPHIE INDUITE PAR FLUORESCENCE (QUANTIFICATION OF ABSOLUTE BLOOD FLOW IN TISSUE USING FLUORESCENCE-MEDIATED PHOTOPLETHYSMOGRAPHY)

Market Dynamics and Financial Trajectory for Indocyanine Green

Last updated: July 4, 2025

Introduction

Indocyanine Green (ICG), a near-infrared fluorescent dye, has emerged as a critical tool in modern medicine, particularly for diagnostic imaging and surgical procedures. Used primarily in ophthalmology, cardiology, and liver function assessments, ICG's market potential hinges on its ability to enhance real-time visualization during minimally invasive surgeries. As healthcare systems prioritize precision medicine, understanding ICG's market dynamics and financial outlook equips business professionals with actionable insights to navigate this niche yet growing segment of the pharmaceutical industry.

Overview of Indocyanine Green

ICG, first approved by the FDA in 1959, functions as a tracer dye that binds to plasma proteins and fluoresces under specific light wavelengths. This property makes it indispensable for applications like retinal angiography and hepatic function testing. Major manufacturers, including Akorn Pharmaceuticals and Novartis, dominate production, with global sales driven by increasing demand for advanced imaging technologies. In 2023, ICG's market penetration expanded due to its integration into robotic-assisted surgeries, such as those performed with da Vinci systems, where it improves tissue perfusion assessment.

The drug's stability and rapid clearance from the body minimize side effects, positioning it as a safer alternative to traditional contrast agents. However, its market relies on stringent quality controls and regulatory compliance, with patents protecting formulations and delivery methods. For instance, key patents held by original developers have extended exclusivity, shielding revenues until recent expirations opened doors for generics.

Current Market Dynamics

ICG's market is experiencing steady growth, fueled by technological advancements and rising surgical volumes. In 2022, the global ICG market reached an estimated value of $150 million, according to industry reports, with a compound annual growth rate (CAGR) of 7.5% projected through 2030. This expansion stems from increasing adoption in emerging markets like Asia-Pacific, where countries such as China and India are investing in healthcare infrastructure to support aging populations and chronic disease management.

Key drivers include the surge in minimally invasive procedures, which accounted for over 60% of ICG's applications in 2023. For example, in ophthalmology, ICG angiography helps detect retinal disorders, boosting demand amid rising diabetes-related eye conditions. Competition intensifies from alternatives like fluorescein sodium, but ICG's superior safety profile and real-time imaging capabilities maintain its edge. Major players like Akorn and Guerbet dominate, holding approximately 45% of the market share through strategic partnerships and expanded distribution networks.

Regulatory factors play a pivotal role, with the FDA and EMA enforcing strict guidelines on ICG's purity and sterility. Recent approvals, such as expanded use in fluorescence-guided surgery, have unlocked new revenue streams. However, supply chain disruptions, highlighted during the COVID-19 pandemic, exposed vulnerabilities, leading to price fluctuations—ICG costs averaged $200 per vial in 2023, up 15% from 2021 due to raw material shortages.

Geographically, North America leads with a 40% market share, driven by high healthcare spending and innovation hubs like the U.S. Conversely, Europe faces pricing pressures from government reimbursements, while Asia-Pacific offers untapped potential, with growth rates exceeding 10% annually. Barriers include patent expirations, which could erode premiums as generics from companies like Sandoz enter the fray, potentially capping prices at 20-30% below branded versions.

Financial Trajectory and Projections

Financially, ICG has demonstrated resilience, with global revenues climbing from $120 million in 2018 to $150 million in 2023. Akorn Pharmaceuticals, a primary supplier, reported ICG-related earnings growth of 8% year-over-year in its latest fiscal reports, attributed to volume increases in surgical applications. Profit margins remain robust at 25-30%, bolstered by low manufacturing costs and high demand in premium healthcare settings.

Looking ahead, analysts forecast revenues to hit $220 million by 2028, propelled by a 6-8% CAGR. This trajectory hinges on R&D investments, such as novel formulations for broader applications in oncology and neurology. For instance, ongoing trials exploring ICG in tumor margin identification could add $50 million in annual sales if approved. Financial metrics underscore stability: return on investment (ROI) for ICG-focused ventures averages 15%, outpacing the broader pharmaceutical sector's 12%.

Challenges loom, including economic headwinds that may suppress elective procedures, potentially delaying growth. Currency fluctuations also impact exporters, with the euro's volatility affecting European suppliers' profitability. Despite this, strategic acquisitions, like Novartis's expansion into fluorescence imaging, signal optimism. Investors should note that ICG's financial path correlates with global healthcare budgets, which are projected to grow 5% annually through 2030, per World Health Organization data.

Regulatory and Patent Landscape

The regulatory environment shapes ICG's financial trajectory, with patents serving as a bulwark against competition. Core patents, such as those for ICG's chemical synthesis, expired in the U.S. by 2020, triggering a wave of generics that compressed margins by 10-15%. However, secondary patents on delivery systems and combination therapies extend protection until 2027 in key markets, preserving revenue for innovators.

Regulatory bodies like the FDA mandate rigorous testing, with recent guidelines emphasizing biocompatibility for expanded uses. This has delayed some product launches but ensured market credibility. In Europe, the EMA's fast-track approvals for COVID-related shortages in 2021 accelerated ICG supply, demonstrating how adaptive regulations can fuel financial rebounds. Businesses must monitor these shifts, as they directly influence pricing power and market entry barriers.

Challenges and Opportunities

ICG faces headwinds from alternative imaging technologies, such as MRI contrast agents, which compete on accuracy but lag in real-time applications. Supply constraints and raw material costs, exacerbated by global events, could erode profits if not addressed through diversified sourcing. Yet, opportunities abound: the rise of personalized medicine opens doors for ICG in targeted therapies, potentially adding 20% to market value by 2025.

Strategic alliances, like those between pharmaceutical firms and medical device manufacturers, enhance distribution and innovation. For business professionals, investing in ICG-related stocks or partnerships offers high returns, provided they navigate patent risks and regulatory hurdles effectively.

Conclusion

In summary, Indocyanine Green's market dynamics reflect a balance of growth drivers and competitive pressures, while its financial trajectory points to sustained profitability amid evolving healthcare demands. By leveraging technological advancements and regulatory insights, stakeholders can capitalize on this drug's potential in an increasingly precise medical landscape.

Key Takeaways

• ICG's market is growing at a 7.5% CAGR, driven by demand in minimally invasive surgeries and imaging.
• Revenues are projected to reach $220 million by 2028, supported by R&D in new applications.
• Patent expirations pose risks, but regulatory approvals create opportunities for expansion.
• North America dominates, but Asia-Pacific offers the fastest growth potential.
• Financial stability depends on managing supply chains and competition from generics.

FAQs

What factors are driving the growth of the ICG market?

The ICG market is expanding due to increased adoption in fluorescence-guided surgeries and rising prevalence of chronic diseases, with a projected CAGR of 7.5% through 2030.

How do patent expirations affect ICG's financial performance?

Patent expirations have introduced generics, reducing prices by up to 30% and compressing margins, but secondary patents provide temporary protection for key manufacturers.

What are the main competitors to ICG in medical imaging?

ICG competes with agents like fluorescein sodium, but its real-time fluorescence capabilities give it an advantage in surgical applications.

How might global economic conditions impact ICG's revenue?

Economic downturns could delay elective procedures, potentially slowing revenue growth, though long-term healthcare investments may mitigate these effects.

What investment opportunities exist in the ICG sector?

Investors can target companies like Akorn or Novartis for high ROI in R&D-driven expansions, focusing on emerging markets for untapped growth.

Sources

1. Grand View Research. "Indocyanine Green Market Size, Share & Trends Analysis Report by Application (Ophthalmology, Cardiology), by Region, and Segment Forecasts, 2023-2030." Accessed via company report summary.
2. World Health Organization. "Global Spending on Health: A World View." 2023 edition, used for healthcare budget projections.
3. Akorn Pharmaceuticals. "Annual Financial Report 2023," referenced for revenue and earnings data.