INDIUM IN-111 OXYQUINOLINE - Generic Drug Details

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What are the generic drug sources for indium in-111 oxyquinoline and what is the scope of patent protection?

Indium in-111 oxyquinoline is the generic ingredient in one branded drug marketed by Bwxt Itg and Ge Healthcare, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for INDIUM IN-111 OXYQUINOLINE

US Patents:	0
Tradenames:	1
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	17
What excipients (inactive ingredients) are in INDIUM IN-111 OXYQUINOLINE?	INDIUM IN-111 OXYQUINOLINE excipients list
DailyMed Link:	INDIUM IN-111 OXYQUINOLINE at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for INDIUM IN-111 OXYQUINOLINE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D08AH	Quinoline derivatives
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

G01AC	Quinoline derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

R02AA	Antiseptics
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for INDIUM IN-111 OXYQUINOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	019044-001	Dec 24, 1985	AP	RX	Yes	Yes
Bwxt Itg	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	202586-001	Jul 25, 2018	AP	RX	No	No

Expired US Patents for INDIUM IN-111 OXYQUINOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	019044-001	Dec 24, 1985	4,335,095

Indium In-111 Oxyquinoline Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 5, 2026

Indium In-111 oxyquinoline is a mature, niche diagnostic radiopharmaceutical used primarily to label autologous leukocytes for scintigraphic localization of infection and inflammation. Its commercial profile is defined by low procedure volume, short isotope shelf life, hospital-based preparation, and competition from technetium-99m leukocyte labeling, fluorodeoxyglucose PET, gallium-68 imaging, MRI, and CT. The product has limited identifiable patent or exclusivity protection in the United States, no meaningful biosimilar risk, and no publicly reported standalone revenue.

What is Indium In-111 oxyquinoline used for?

Indium In-111 oxyquinoline is a radioactive labeling agent. Clinicians incubate it ex vivo with a patient’s leukocytes, reinject the labeled cells, and perform gamma-camera imaging to identify sites of infection or inflammation.

The product is not a conventional small-molecule therapeutic. Oxyquinoline, also known as oxine, functions as a chelating and membrane-permeating agent that transfers indium-111 into leukocytes. The labeled cells then migrate toward inflammatory or infectious sites.

Key product characteristics include:

Attribute	Indium In-111 oxyquinoline
Active radionuclide	Indium-111
Chelating agent	Oxyquinoline, or oxine
Primary use	Labeling autologous leukocytes
Imaging modality	Planar scintigraphy and SPECT
Physical half-life	Approximately 67.3 hours
Principal photon energies	Approximately 171 and 245 keV
Typical clinical setting	Hospital nuclear medicine and radiopharmacy
Administration	Ex vivo cell labeling followed by reinjection
FDA regulatory category	Diagnostic radiopharmaceutical
Biosimilar exposure	None
Primary commercial constraint	Isotope supply, preparation time, and logistics

The FDA labeling describes use for localization of sites of infection and inflammation after radiolabeling autologous leukocytes. The procedure requires blood collection, cell separation, radiolabeling, quality control, and reinfusion. That workflow limits throughput and makes the product less convenient than direct-injection imaging agents. (DailyMed, n.d.)

What is the FDA regulatory status of Indium In-111 oxyquinoline?

Indium In-111 oxyquinoline is an established FDA-regulated diagnostic radiopharmaceutical rather than a newly developed molecular imaging product. Commercial availability depends on the manufacturer, radiopharmacy, and hospital supply chain.

The product’s regulatory value is based on an approved clinical use and established handling procedures, not on market exclusivity. The approval framework for radiopharmaceuticals generally requires controls for radionuclide identity, radiochemical purity, sterility, endotoxins, labeling accuracy, and expiration dating.

What is the Orange Book status?

Public FDA Orange Book data do not identify a material active patent or regulatory exclusivity position comparable to those associated with recently approved branded drugs. Indium In-111 oxyquinoline is an old diagnostic product with no identifiable current U.S. patent barrier that would prevent competing manufacture of the same approved product category. (U.S. Food and Drug Administration, n.d.-a)

The commercial implications are significant:

• No meaningful new-drug exclusivity remains.
• No pediatric exclusivity is commercially relevant.
• No current patent-based launch embargo is apparent.
• Manufacturers compete primarily through isotope access, radiopharmacy coverage, quality systems, service reliability, and pricing.
• Regulatory approval and manufacturing compliance remain operational barriers even when patent protection is absent.

What patents protect Indium In-111 oxyquinoline?

No active U.S. patent estate has been identified as a primary barrier to commercial supply of Indium In-111 oxyquinoline. The underlying chemistry is old, and the product is based on a known radionuclide-labeling method rather than a recently patented molecular entity.

Patent category	Current commercial significance
Composition-of-matter patent	No meaningful active protection identified
Oxyquinoline labeling chemistry	Historical technology; likely expired patent coverage
Indium-111 production	Production know-how may remain proprietary, but does not create product exclusivity
Leukocyte-labeling method	Potential process know-how, but no apparent market-blocking U.S. patent
Formulation patent	No material modern formulation estate identified
Method-of-use patent	No current broad exclusivity identified
Manufacturing patent	Operational know-how may matter; patent barrier is not apparent
Orange Book-listed patent	No material listing identified

Patent expiration dates for the original labeling technology are not commercially decisive because any early patents would have expired decades ago. The main remaining intellectual-property value lies in manufacturing procedures, radiopharmacy automation, quality-control methods, logistics, and customer relationships.

Are there formulation patents?

A meaningful formulation patent estate is not apparent. The commercial product is typically an aqueous sterile radiolabeling solution with a short dating period tied to radioactive decay and product stability. The formulation does not have the complex delivery-system profile seen in depot injectables, liposomal products, inhaled products, or biologics.

Are there method-of-use patents?

No broad, active method-of-use exclusivity has been identified that would prevent competing use of Indium In-111-labeled leukocytes for infection or inflammation imaging. Any historical method claims would face the age of the technology and the limited scope of modern patent terms.

When does Indium In-111 oxyquinoline lose exclusivity?

Indium In-111 oxyquinoline has effectively already lost market exclusivity. The product is commercially mature, and its competitive position does not depend on a remaining patent term.

The relevant timeline is:

Period	Commercial event
Early development era	Indium-111 leukocyte-labeling technology established
1980s and later	Clinical use adopted for infection and inflammation imaging
Subsequent decades	Original composition and process patent terms expired
Current market	Competition based on supply, regulatory compliance, and clinical preference

There is no expected “patent cliff” comparable to a branded drug losing exclusivity in a specific future year. The market is already in a post-exclusivity phase.

Are there Paragraph IV challenges or generic launch risks?

A conventional Paragraph IV litigation event is not a central risk for this product. Paragraph IV litigation usually concerns an abbreviated new drug application referencing an active listed patent for a branded drug. The absence of a material active Orange Book patent estate reduces the likelihood that a new entrant would need to defeat a significant patent position.

The more relevant risks are regulatory and operational:

1. A manufacturer must obtain the appropriate FDA authorization.
2. The product must meet sterile manufacturing and radiopharmaceutical quality requirements.
3. The manufacturer must secure indium-111 supply.
4. The supply chain must deliver product within a narrow radioactive shelf-life window.
5. Hospitals must have validated procedures for leukocyte isolation and reinfusion.
6. State radiation-control and radioactive-material requirements must be satisfied.

A new entrant could therefore face a difficult launch despite minimal patent risk. The barrier is execution, not exclusivity.

What companies supply or compete with Indium In-111 oxyquinoline?

The supply base is fragmented by geography and can include commercial radiopharmaceutical manufacturers, nuclear pharmacies, hospital radiopharmacies, and specialty compounding or radiopharmacy providers. Public sources do not provide a complete, consistently reported global market-share table for Indium In-111 oxyquinoline.

Commercial competition occurs at three levels.

Product-level competition

The direct comparator is technetium-99m-labeled leukocytes, often prepared using established leukocyte-labeling procedures. Technetium-99m has a shorter half-life and different imaging logistics but is widely available in nuclear medicine.

Modality-level competition

The principal substitutes include:

• F-18 fluorodeoxyglucose PET/CT for inflammatory and infectious disease imaging.
• Gallium-68 PET agents in selected infection or inflammation indications.
• MRI, particularly where soft-tissue or osteomyelitis assessment is required.
• Contrast-enhanced CT.
• Ultrasound for accessible soft-tissue and vascular conditions.
• Clinical assessment and microbiologic testing in lower-risk cases.

Workflow-level competition

Hospitals may replace In-111 leukocyte imaging with direct-injection imaging, PET/CT, or non-radioactive diagnostic workups when faster scheduling, lower labor intensity, or higher spatial resolution is preferred.

How strong is the patent estate for Indium In-111 oxyquinoline?

The patent estate is weak as a commercial defense. A practical assessment is:

Factor	Assessment
Composition-of-matter protection	Weak or expired
Formulation protection	Limited
Method-of-use protection	Limited
Manufacturing protection	Moderate operational value, low exclusionary value
Regulatory exclusivity	No material current exclusivity identified
Freedom to launch	Relatively favorable from a patent perspective
Supply-chain defensibility	More important than patents
Litigation exposure	Low relative to branded pharmaceuticals

Manufacturing know-how can still create a competitive advantage. This includes leukocyte recovery, labeling efficiency, sterility controls, radiochemical purity, release testing, and delivery scheduling. These factors can reduce failed doses and improve hospital retention, even without patent protection.

What affects the financial trajectory of Indium In-111 oxyquinoline?

No reliable public source reports standalone global sales, gross margin, or product-level operating profit for Indium In-111 oxyquinoline. Private radiopharmacy suppliers and diversified nuclear-medicine companies generally report broader portfolios rather than individual product revenue.

The financial trajectory is therefore best assessed through market drivers.

Demand drivers

Demand is supported by:

• Continued use in complex infection and inflammation cases.
• Hospital nuclear medicine capacity.
• Need for delayed imaging of labeled leukocytes.
• Use in selected prosthetic joint, vascular graft, osteomyelitis, and fever-of-unknown-origin evaluations.
• Availability at institutions without immediate access to advanced PET tracers.

Demand constraints

Demand is constrained by:

• Competition from FDG PET/CT.
• Longer and labor-intensive leukocyte-labeling workflow.
• Need for blood handling and reinfusion.
• Declining use of older planar and SPECT-based diagnostic methods in some centers.
• Availability of MRI and CT.
• Radiation exposure and scheduling complexity.
• Limited physician familiarity outside nuclear medicine and infectious-disease referral centers.

Cost and margin structure

The product has unusual economics. The raw drug component is only one part of the episode cost. Labor, cell processing, quality control, radioactive-material handling, isotope procurement, waste management, and same-day delivery can determine profitability.

The short half-life of indium-111 creates inventory risk. Unused doses decay and cannot be resold after the relevant clinical window. Suppliers therefore need reliable ordering forecasts and geographically dense delivery routes.

The likely financial profile is:

Metric	Directional assessment
Revenue growth	Mature to declining in some developed markets
Price growth	Potentially positive, but limited by hospital budgets and substitutes
Volume growth	Low; dependent on specialized use
Gross margin	Sensitive to isotope cost and failed-dose rates
Capital intensity	Moderate because of radiopharmacy and quality infrastructure
Cash-flow volatility	Higher than ordinary injectables because of decay and scheduling
Product concentration risk	Low for diversified suppliers, high for niche providers
Strategic value	Portfolio completeness and customer retention rather than blockbuster revenue

What licensing deals affect the product?

No major publicly disclosed licensing transaction appears to have materially redefined the commercial market for Indium In-111 oxyquinoline. The product is an established radiopharmaceutical, so commercial arrangements are more likely to involve:

• Isotope supply agreements.
• Radiopharmacy distribution contracts.
• Contract manufacturing.
• Hospital network purchasing.
• Regional rights to distribute radiopharmaceutical products.
• Manufacturing and quality-control technology transfers.

This differs from newer radioligand products, where licensing payments and territorial rights can reach substantial values. For In-111 oxyquinoline, the product is more likely to be included in a broader radiopharmaceutical portfolio than licensed as a standalone growth asset.

What is the litigation status?

No major current patent litigation involving Indium In-111 oxyquinoline has been identified as a defining market event. The absence of a material active patent estate limits the basis for an infringement campaign.

Potential disputes would more likely involve:

• Manufacturing quality.
• Product shortages.
• Contract supply obligations.
• Hospital or radiopharmacy compounding practices.
• Regulatory compliance.
• Radiation safety.
• Labeling and adverse-event reporting.

No prominent settlement agreement or Paragraph IV settlement is associated with the product in the public record reviewed for this analysis.

What generic entry scenarios exist?

A new entrant could pursue three commercial strategies.

Full commercial product entry

The entrant would obtain authorization for a finished Indium In-111 oxyquinoline product and compete on price, coverage, and reliability. This approach requires isotope procurement, sterile manufacturing, validation, distribution, and hospital support.

Radiopharmacy preparation

A hospital or regional radiopharmacy could prepare the labeled product under applicable regulatory and compounding frameworks. This model can reduce dependence on a national supplier but increases local compliance and quality-control responsibilities.

Substitution with another imaging modality

The strongest competitive threat may not be another In-111 product. It may be migration to FDG PET/CT, technetium-99m leukocytes, MRI, CT, or gallium-68 imaging.

The most plausible market scenario is stable but narrow demand, with gradual erosion in centers that have access to more modern imaging modalities. A sudden generic-price collapse is less likely because isotope logistics and procedure labor limit the impact of low ex-factory pricing.

What is the geographic market outlook?

The product is most defensible in regions with:

• Established nuclear medicine departments.
• Reliable indium-111 supply.
• Reimbursement for leukocyte scintigraphy.
• Specialized infection-imaging referrals.
• Hospital infrastructure for cell labeling.

North America and Western Europe have the strongest installed nuclear medicine base. Emerging markets may have lower access because the product requires specialized radiopharmacy infrastructure and a dependable isotope supply chain.

Geographic competition is local even when the manufacturer is national. Radiopharmaceutical products cannot always be shipped economically across long distances because radioactive decay reduces usable activity. Regional production and distribution density therefore matter more than conventional pharmaceutical sales-force scale.

Key Takeaways

• Indium In-111 oxyquinoline is a mature diagnostic radiopharmaceutical, not a growth-stage therapeutic.
• Its primary use is ex vivo labeling of autologous leukocytes for infection and inflammation imaging.
• No material active U.S. patent or Orange Book exclusivity position has been identified.
• Paragraph IV litigation, biosimilar competition, and patent-cliff risk are low.
• The principal commercial barriers are isotope supply, sterile processing, radiopharmacy logistics, and hospital workflow.
• FDG PET/CT, technetium-99m leukocytes, gallium-68 imaging, MRI, and CT are the main competitive pressures.
• Public sources do not report standalone product revenue, making precise financial forecasting unavailable.
• The likely trajectory is mature to gradually declining volume, with pricing and margin determined by supply reliability rather than intellectual-property protection.
• The product’s strategic value is portfolio breadth and customer retention, not blockbuster revenue potential.

FAQs About Indium In-111 Oxyquinoline

Is Indium In-111 oxyquinoline a branded drug?

It is an established diagnostic radiopharmaceutical supplied under product and manufacturer-specific names. Its commercial identity is less concentrated than that of a conventional branded prescription drug.

Does Indium In-111 oxyquinoline have biosimilar competition?

No. Biosimilar regulation applies to biologic products. Indium In-111 oxyquinoline is a radiolabeled small-molecule diagnostic product.

How long does Indium In-111 oxyquinoline remain radioactive?

Indium-111 has a physical half-life of approximately 67.3 hours. The practical usable period is shorter because product activity, imaging schedules, and radiochemical stability must remain within labeled specifications.

Is Indium In-111 oxyquinoline used for cancer imaging?

Its principal labeled use is infection and inflammation imaging through radiolabeled leukocytes. It is not a general-purpose oncology imaging agent, although indium-111 has been used in other radiopharmaceutical applications.

What is the main investment risk for an Indium In-111 oxyquinoline supplier?

The main risk is demand substitution and operational inefficiency. PET, MRI, CT, and alternative leukocyte-labeling methods can reduce utilization, while isotope decay, failed labeling, and regional distribution costs can compress margins.

References

1. DailyMed. (n.d.). Indium In 111 oxyquinoline injection prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (n.d.-b). Radiopharmaceuticals and FDA regulatory information. https://www.fda.gov/drugs/

4. International Atomic Energy Agency. (n.d.). Indium-111 production and applications in nuclear medicine. https://www.iaea.org/

5. Society of Nuclear Medicine and Molecular Imaging. (n.d.). Appropriate use and practice guidance for labeled leukocyte imaging. https://snmmi.org/ ━