IC-GREEN Drug Patent Profile

Which patents cover Ic-green, and what generic alternatives are available?

Ic-green is a drug marketed by Renew Pharms and is included in one NDA.

The generic ingredient in IC-GREEN 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 Ic-green

A generic version of IC-GREEN was approved as indocyanine green by RENEW PHARMS on November 21^st, 2007.

Summary for IC-GREEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Patent Applications:	7,127
Drug Prices:	Drug price information for IC-GREEN
What excipients (inactive ingredients) are in IC-GREEN?	IC-GREEN excipients list
DailyMed Link:	IC-GREEN at DailyMed

See drug prices for IC-GREEN

US Patents and Regulatory Information for IC-GREEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	No
Renew Pharms	IC-GREEN	indocyanine green	INJECTABLE;INJECTION	011525-004	Approved Prior to Jan 1, 1982		DISCN	No	No

IC-GREEN (indocyanine green) market dynamics and financial trajectory

IC-GREEN (indocyanine green, “ICG”) sells into surgical imaging and critical-care imaging workflows. Near-term demand is driven by uptake of fluorescence-guided surgery, liver and biliary assessment applications, and end-market penetration by hospital imaging service lines. Commercial trajectory is shaped more by evidence adoption, formulary inclusion, and distribution access than by patent-driven pricing power, because IC products are typically mature, supply-constrained in certain geographies, and frequently face broad generic or repackager competition where IP is thin.

Below is a structured market and financial view of how IC-GREEN can perform, what moves revenue, and which risks change the trajectory.

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What is IC-GREEN (indocyanine green) and where does it get used commercially?

IC-GREEN is indocyanine green used as a fluorescent imaging agent for visualization of tissues and anatomy under near-infrared light. Commercially, ICG is used when clinicians want real-time visualization of perfusion, biliary anatomy, or tissue boundaries without relying on ionizing radiation.

Key commercial use cases that drive hospital purchasing

• Fluorescence-guided surgery (perioperative perfusion, margin assessment, lymphatic mapping in some protocols).
• Hepatobiliary imaging (liver function and biliary tract assessment workflows).
• Critical-care and vascular imaging workflows where facilities adopt ICG-based monitoring protocols.

Buying centers and budget lines

• Surgical services (operating room consumables budget).
• Imaging and perioperative oncology programs.
• Hospital pharmacy and therapeutics committees for inclusion in formularies.
• Supply chain vendors that standardize preferred brands.

Featured snippet answer: IC-GREEN is an indocyanine green fluorescence imaging agent used in surgery and clinical imaging to guide visualization of anatomy, perfusion, and hepatobiliary pathways under near-infrared light.

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How big is the ICG/IC-GREEN market and what demand growth levers matter most?

Demand growth is supply- and protocol-driven, with adoption rising as hospitals expand fluorescence-capable platforms and as clinicians standardize ICG-guided pathways.

Growth levers

• Procedure volume growth in specialties that use fluorescence guidance (general surgery, colorectal, hepatobiliary, breast surgery, and oncology pathways).
• Technology enablement: hospitals that add near-infrared imaging systems convert imaging workflows from optional to routine.
• Clinical guideline penetration: usage expands when protocols become embedded in institutional pathways and peer-reviewed evidence becomes practice.
• Training and workflow integration: adoption rises when pharmacy stocking, dosing protocols, and imaging team training are standardized.

Constraining factors

• Competitive ICG supply: where multiple labeled products or repackaged sources exist, price pressure increases.
• Hospital procurement cycles: formularies and OR standardization slow conversion from pilot studies to routine purchasing.
• Value demonstration burden: hospitals scrutinize cost per case and outcomes, especially where payers do not separately reimburse imaging agents.

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Which factors drive IC-GREEN pricing power and gross margin in hospital procurement?

Pricing is mainly constrained by procurement competition and by whether payers treat the agent as a bundled OR cost. In many settings, ICG is purchased as a consumable and priced relative to alternative sources and competing imaging agents.

What typically determines net price

• Number of equivalent labeled products on contract (brand versus competitor, package size, and concentration).
• Hospital group purchasing organization (GPO) contracts and conversion clauses.
• Volume commitments and service-level guarantees.
• Data requirements: hospital pharmacy may request stability, handling, and evidence on protocol performance.

How gross margin is affected

• Manufacturing yield and batch release costs: ICG production is chemistry-intensive and can be sensitive to impurities and release specifications.
• Inventory carrying cost and expiry risk: short shelf-life relative to some competitors can erode realized margins.
• Trade terms and distribution markup: net margin compresses if intermediaries take a larger share of distribution economics.

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What is the typical sales mix for IC-GREEN across geographies and channels?

Sales are usually dominated by hospital direct contracts rather than retail, because ICG is administered in monitored clinical workflows and requires procedural integration.

Channel dynamics

• Direct hospital sales and distributor partnerships are common.
• Academic medical centers adopt earlier based on clinical evidence and investigator-led protocols.
• Community hospitals adopt later after standardization and evidence diffusion.

Geographic pattern logic

• Higher uptake where surgical oncology and hepatobiliary programs are dense.
• Adoption increases where fluorescence-compatible imaging systems are widespread.
• Regulatory labeling and reimbursement context affect inclusion in care pathways.

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When does IC-GREEN face generic entry risk or pricing compression?

Generic or repackager pressure is the dominant commercial risk for mature imaging agents when brand IP coverage is limited, narrow, or already expired. For ICG, real-world entry risk usually hinges on:

• Patent estate strength around specific formulations, dosing regimens, packaging, or methods.
• Whether a brand has exclusivity tied to a particular labeled use in a specific jurisdiction.
• Whether the market is dominated by one supplier versus multiple interchangeable options.

Featured snippet answer: The biggest IC-GREEN entry risk is pricing compression from generics or repackagers if core IP does not cover broadly the labeled product configuration and if hospitals view sources as clinically interchangeable.

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How strong is the patent estate for IC-GREEN and what does it mean for exclusivity?

A precise exclusivity and expiration view requires a product-specific Orange Book and patent list. For IC-GREEN, the market dynamics depend on which specific “IC-GREEN” label and strength/package are sold, and in which countries, because indocyanine green is frequently marketed in multiple strengths and presentations.

Sales trajectory implication (directional):

Last updated: June 20, 2026

• If the brand has thin, narrow patents around only formulation or only a single labeled method-of-use, net pricing often compresses as competitors launch “equivalent” products.
• If the brand has enforceable patents tied to a specific imaging method-of-use plus robust labeling, branded economics persist longer, especially in large academic accounts that standardize protocols.

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What market events typically shift IC-GREEN utilization and revenue?

Revenue in hospital consumables shifts when clinical pathways change and when system-level purchasing decisions occur.

Event types with outsized impact

• New fluorescence imaging adoption (purchase of compatible near-infrared systems).
• Expanded indication uptake in perioperative oncology, hepatobiliary surgery, or perfusion-guided workflows.
• Hospital conversion from “pilot” to “standard of care.”
• National contracting events where GPO or health system group purchasing switches preferred suppliers.
• Supply disruptions or quality holds that force temporary substitution or accelerated procurement.

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How do reimbursement and payer coverage affect IC-GREEN financial performance?

Most ICG use is billed within surgical episodes where imaging agents are treated as part of the care bundle or device-related consumables. Where reimbursement is not separately supported, hospitals focus on:

• clinical outcomes that reduce complications or length of stay,
• operational workflow benefits,
• and total cost per case.

Practical effect on revenue

• If coverage is bundled, brand value is expressed through outcomes and formulary inclusion rather than stand-alone payer reimbursement.
• If some settings support separate reimbursement, adoption and switching can accelerate faster.

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How does IC-GREEN compare with alternative imaging agents and fluorescence technologies?

ICG competes with:

• other fluorescence tracers used in specific indications,
• and non-fluorescence visualization approaches (anatomic imaging, intraoperative ultrasound, and other surgical guidance technologies).

Competitive substitution risk

ICG adoption is most threatened when:

• competing agents have stronger evidence for the same endpoints,
• a hospital’s imaging platform is optimized around another tracer,
• or clinicians consider ICG less consistent for a specific use case.

Competitive moat options

• Strong evidence in practice protocols.
• Platform compatibility.
• Reliability of supply and consistent concentration/handling.

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What does the financial trajectory look like as IC-GREEN scales within hospitals?

The financial trajectory is typically nonlinear: early revenue grows with academic and high-volume surgical centers, then accelerates as protocol standardization spreads, and later flattens as commoditization and competitive supply increase.

Typical lifecycle shape

1. Launch or reactivation phase: adoption in specialty centers; higher pricing with limited competition.
2. Expansion phase: broader hospital conversion; growth rises with procedure volumes and education.
3. Maturity/commoditization phase: price competition from generics/repackagers; growth slows or shifts to volume-based contracts.
4. Platform dependency phase: revenue ties to installed base of near-infrared imaging systems and standard-of-care protocols.

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What metrics investors and operators should track for IC-GREEN performance?

Commercial KPI set

• Active account penetration: number of hospitals ordering within last 6 to 12 months.
• Units per procedure proxy: ICG vials per procedure category.
• Net price vs list: GPO and distributor contract impact.
• Share of contract shelf: preferred status in large health systems.
• Repeat purchasing rate by service line.

Financial KPI set

• Gross margin by contract tier (direct vs distributor).
• Working capital and inventory turns (expiry and shelf-life management).
• Sales and marketing efficiency tied to account conversion events.

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What generic entry scenarios could change IC-GREEN revenue and margin?

Scenario A: Broad branded-to-generic substitution

• Hospitals switch preferred suppliers at contract renewal.
• Net price falls across the base.
• Volume offsets are partial due to brand familiarity and protocol differences.

Margin outcome: compresses; revenue may decline unless uptake offsets.

Scenario B: Limited substitution due to protocol standardization

• Some accounts keep branded ICG due to workflow integration, training, and surgeon preference.
• Substitution occurs mainly in lower-volume facilities.

Margin outcome: slower compression; revenue declines gradually.

Scenario C: Supply-side displacement

• Quality issues or shortages at a key source accelerate substitution but may later reverse.

Margin outcome: temporary uplift for surviving suppliers; later normalization.

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How do manufacturing and supply chain risks affect IC-GREEN availability and earnings?

ICG supply issues usually show up as:

• delayed shipments due to batch release or sterility/impurity specs,
• allocation periods where hospitals accept substitutes with different packaging,
• and increased distributor inventory requirements.

Financial impact pathways

• Backorders reduce recognized sales.
• Expedited shipping and lot management raise costs.
• Substitution leakage permanently shifts share in some accounts.

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Key Takeaways

• IC-GREEN demand is driven by fluorescence-guided surgery adoption, hepatobiliary workflow penetration, and installed base of near-infrared imaging systems.
• Net pricing power is typically limited by hospital procurement dynamics and generic/repackager availability; gross margin depends on manufacturing yield, shelf-life management, and contract mix.
• The commercial trajectory follows a standard lifecycle: early niche penetration, broad hospital scaling, then later pricing compression as substitution expands.
• Revenue is most sensitive to account conversion events (pilot to standard of care), national contracting, and supply continuity.

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FAQs

1. How does fluorescence-guided surgery adoption change IC-GREEN purchasing frequency?
2. What hospital procurement levers most influence IC-GREEN net price and contract shelf status?
3. What events (system installs, guideline updates, contracting cycles) typically trigger step-changes in IC-GREEN revenue?
4. Do payers reimburse indocyanine green separately, or is it bundled into surgical costs?
5. Which competitive substitutes create the highest substitution risk for IC-GREEN in surgical imaging workflows?

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References

(No sources cited because no IC-GREEN product-specific financials, Orange Book/patent list, or FDA/labeling dataset were provided.)