Last Updated: May 3, 2026

IC-GREEN Drug Patent Profile


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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 21st, 2007.

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Summary for IC-GREEN
US Patents:0
Applicants:1
NDAs:1

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

Investment Scenario and Fundamentals Analysis for IC-GREEN

Last updated: April 24, 2026

What is IC-GREEN and what exactly is being marketed?

IC-GREEN is the brand name for indocyanine green (ICG), a fluorescent dye used in medicine for optical imaging. In practice, “IC-GREEN” is not a single novel drug platform; it is an ICG formulation/packaging identity that typically maps to the same underlying active ingredient: indocyanine green.

Core mechanism (fundamentals anchor): indocyanine green emits near-infrared fluorescence after excitation, enabling visualization of vascular flow and tissue uptake. This supports use cases in areas such as surgery and oncology workflows where surgeons or imaging systems benefit from real-time visualization.

What indications and use cases drive commercial value?

ICG’s value proposition is usage-dependent. The investment fundamentals are shaped less by systemic pharmacology and more by:

  • Procedure frequency (how often hospitals perform the relevant surgeries)
  • Adoption of fluorescence imaging workflows
  • Compatibility with imaging systems (platform integration)
  • Clinical standard-of-care fit (where guidelines and reimbursement support use)

From an investment standpoint, the key commercial question is not “efficacy in isolation,” it is “where ICG is reimbursed and embedded in protocols.”

Where does IC-GREEN fit in the competitive landscape?

ICG is a widely used dye and faces competition across three dimensions:

  1. Competing fluorescent dyes (in some workflows)
  2. Competing imaging workflow vendors (systems that can use different fluorophores)
  3. Same-ingredient substitutes (other ICG brands or generics depending on market and regulatory pathway)

Investment implication: Pricing power is structurally weaker where:

  • ICG is substitutable across brands,
  • procurement is driven by tender economics,
  • and imaging platforms support multiple dyes.

What are the patent and exclusivity fundamentals?

For an investment-grade analysis, the determinant is whether “IC-GREEN” is protected as:

  • a new chemical entity (unlikely for ICG),
  • a new formulation with enforceable composition-of-matter or method-of-use claims (possible but market-specific),
  • or a packaging/trade dress that does not prevent generic substitution.

Commercial reality for ICG-type assets: durable exclusivity usually does not come from the molecule itself, because indocyanine green is a legacy compound. The realistic exclusivity levers are:

  • formulation improvements,
  • delivery device integration,
  • and validated method-of-use claims that map to reimbursed protocols.

Because the request is specifically “IC-GREEN,” any investment view depends on the jurisdiction-specific IP posture of the brand/formulation and the regulatory approval scope tied to that label. Without that label- and jurisdiction-specific dataset, the IP timeline cannot be mapped to investment milestones with defensible accuracy.

What regulatory posture matters most for IC-GREEN?

For ICG products, the regulator signal is label scope. The most investment-relevant regulatory components include:

  • whether the product is approved under a full indication set or narrow use,
  • whether label language supports standardized adoption across hospitals,
  • and whether competing products in the same class have broader or faster-expanding labels.

Regulatory catalysts for ICG brands are typically:

  • label expansions into higher-volume surgical indications,
  • new clinical protocol acceptance,
  • or reimbursement alignment.

What adoption economics should you underwrite?

For hospital-administered fluorescent imaging dyes, adoption is driven by procurement plus protocolization.

Economic drivers to model:

  • Per-procedure drug usage (vial consumption per case)
  • Shelf availability and logistics (cold chain needs if any; packaging format)
  • Training and workflow integration costs
  • Imaging system penetration at target hospitals

Unit economics lens: even small price concessions can materially impact profitability if volume is high and the product is substitutable. Conversely, a formulation that reduces wastage, improves dosing accuracy, or increases signal quality can raise “effective value” in protocols that are sensitive to fluorescence performance.

How do reimbursement and guidelines shape market access?

The investment-quality market thesis requires underwriting where ICG has:

  • established guideline inclusion,
  • procedure reimbursement pathways, and
  • payer acceptance for the relevant fluorescence-assisted workflow.

If reimbursement is inconsistent, sales growth depends on surgeon advocacy and hospital budgets rather than payer pull. If reimbursement is stable, growth depends on competitive pricing and distribution.

What is the likely risk profile for IC-GREEN?

The main investment risks for ICG brands are:

  • substitution risk (same active ingredient or readily interchangeable products),
  • margin compression driven by generic or competitor tendering,
  • label competition if rivals offer broader claims,
  • workflow lock-in risk if hospitals standardize on a competing platform or fluorophore.

What would a defensible investment scenario look like?

An investment scenario must tie to the only robust levers for legacy actives:

  1. Geographic build-out where label access is still expanding
  2. Protocol penetration into high-volume indications
  3. Commercial differentiation through formulation or workflow integration
  4. Channel and tender discipline in procurement-heavy markets

Scenario table: underwriting framework

Dimension Base Case Upside Case Downside Case
Market access Stable label scope in existing accounts Label expansion and faster protocol adoption Narrower label or slower payer uptake
Competitive pressure Tender-based but contained Differentiated workflow positioning keeps share Price-led substitution accelerates
Margin Moderate gross margin with disciplined contracting Margin held via differentiation and bundling Margin compresses due to generics/low-cost entrants
Growth vector Steady procedure-driven volume Faster hospital onboarding and imaging system penetration Slower adoption due to workflow friction

This framework is the only viable structure for legacy fluorescent dyes without claims to novel MOAs.

What diligence points should determine valuation?

For an investor, diligence should center on:

  • Brand-specific regulatory label: exact indications, patient populations, and usage instructions.
  • IP status of the brand/formulation: whether any enforceable claims remain across major jurisdictions.
  • Competitive mapping: active competitors by region, pricing behavior, and procurement patterns.
  • Distribution agreements: exclusivity, hospital coverage, and tender cadence.
  • Clinical evidence tied to label: whether the data used for approval match real-world protocol adoption.

Key takeaways

  • IC-GREEN is an indocyanine green (ICG) fluorescence dye asset where value depends on workflow adoption, label scope, and reimbursement, not novel systemic pharmacology.
  • For valuation, the decisive factors are brand-specific regulatory breadth and any enforceable IP around formulation or methods, because the molecule itself is legacy.
  • The market dynamics are procurement-driven and substitution-prone, so profit durability depends on whether the brand has defensible differentiation that survives tender pricing.

FAQs

Is IC-GREEN a new molecular entity?

No. IC-GREEN is an ICG brand identity built on a legacy active ingredient.

What drives demand for IC-GREEN in hospitals?

Demand tracks procedure volumes and the extent to which fluorescence imaging becomes standardized in reimbursed surgical workflows.

What is the biggest commercial risk for IC-GREEN?

Substitution and margin compression from other ICG brands or generics in tender-based procurement markets.

What type of evidence affects adoption the most?

Clinical evidence that supports label-approved fluorescence workflows and maps to routine surgical protocols that hospitals operationalize.

What determines whether exclusivity meaningfully protects margins?

The remaining enforceable IP tied to the specific IC-GREEN brand, most realistically via formulation or method-of-use claims, rather than the base molecule.


References

[1] European Medicines Agency. “Indocyanine green.” EMA product and assessment resources (accessed 2026-04-24).
[2] U.S. Food and Drug Administration. “Indocyanine green.” FDA drug databases and labeling resources (accessed 2026-04-24).
[3] Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Clinical guidance and practice resources on fluorescence imaging with indocyanine green (accessed 2026-04-24).
[4] Radiological and surgical literature on near-infrared fluorescence imaging with indocyanine green (accessed 2026-04-24).

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