GALLIUM CITRATE GA 67 Drug Patent Profile

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Which patents cover Gallium Citrate Ga 67, and when can generic versions of Gallium Citrate Ga 67 launch?

Gallium Citrate Ga 67 is a drug marketed by Curium, Ge Healthcare, and Lantheus Medcl. and is included in three NDAs.

The generic ingredient in GALLIUM CITRATE GA 67 is gallium citrate ga-67. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gallium citrate ga-67 profile page.

Summary for GALLIUM CITRATE GA 67

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	9
Patent Applications:	68
DailyMed Link:	GALLIUM CITRATE GA 67 at DailyMed

Recent Clinical Trials for GALLIUM CITRATE GA 67

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

Sponsor	Phase
University Hospital, Bordeaux	Phase 2
U.S. Army Medical Research and Development Command	Phase 2
Rahul Aggarwal	Phase 2

See all GALLIUM CITRATE GA 67 clinical trials

US Patents and Regulatory Information for GALLIUM CITRATE GA 67

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Curium	GALLIUM CITRATE GA 67	gallium citrate ga-67	INJECTABLE;INJECTION	018058-001	Approved Prior to Jan 1, 1982	BS	RX	No	No
Ge Healthcare	GALLIUM CITRATE GA 67	gallium citrate ga-67	INJECTABLE;INJECTION	017700-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lantheus Medcl	GALLIUM CITRATE GA 67	gallium citrate ga-67	INJECTABLE;INJECTION	017478-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Gallium Citrate Ga 67 Market Dynamics, Patent Position, and Financial Trajectory

Last updated: October 22, 2026

Gallium citrate Ga 67 is a legacy diagnostic radiopharmaceutical with limited commercial growth potential. Its market is driven by residual use in infection, inflammation, and selected oncology imaging, while PET agents, fluorodeoxyglucose F 18, gallium-68 products, tagged white-blood-cell imaging, and newer molecular diagnostics continue to reduce demand. The product has no meaningful modern patent moat, no biosimilar pathway, and limited public revenue disclosure. Its financial trajectory is best characterized as mature, low-volume, supply-constrained, and structurally declining rather than expansionary.

What is gallium citrate Ga 67 used for?

Gallium citrate Ga 67 injection is a radioactive diagnostic agent administered intravenously for imaging selected tumors and sites of infection or inflammation. Gallium-67 localizes through mechanisms associated with transferrin binding, inflammation, leukocyte activity, and tumor biology.

The product has historically been used for:

• Hodgkin lymphoma and selected non-Hodgkin lymphomas
• Pulmonary and systemic infection
• Fever of unknown origin
• Osteomyelitis
• Sarcoidosis and other inflammatory disorders
• Selected soft-tissue and inflammatory lesions

The radiopharmaceutical is generally used with planar imaging or single-photon emission computed tomography. Its clinical limitations include delayed imaging, relatively high radiation exposure compared with some alternatives, lower spatial resolution than PET, and nonspecific uptake.

Gallium-67 has a physical half-life of approximately 78 hours. Imaging commonly occurs at multiple time points, including approximately 24, 48, and 72 hours after administration. This creates operational disadvantages compared with many PET procedures that can be completed in a shorter cycle. The half-life also increases inventory, transport, and radiation-management requirements.

What is the FDA regulatory status of gallium citrate Ga 67?

Gallium citrate Ga 67 injection is an FDA-approved diagnostic radiopharmaceutical. It is regulated as a drug, but its commercial availability depends on specialized radioactive-isotope production, aseptic manufacturing, packaging, distribution, and nuclear-pharmacy handling.

Regulatory attribute	Gallium citrate Ga 67
Active component	Gallium-67 citrate
Product type	Diagnostic radiopharmaceutical
Administration	Intravenous injection
Imaging modalities	Planar scintigraphy and SPECT
Primary uses	Tumor, infection, and inflammation imaging
FDA pathway	Approved drug product
Biosimilar pathway	Not applicable
Typical supply model	Centralized radiopharmaceutical production and scheduled distribution
Key commercial constraint	Isotope production and declining clinical demand

The product is not a biologic. FDA biosimilar competition therefore does not apply. Competition occurs through alternative diagnostic methods and potentially through other manufacturers of the same or therapeutically similar radiopharmaceutical.

FDA labeling identifies gallium citrate Ga 67 as a diagnostic agent rather than a therapeutic product. Its commercial value depends on clinical utilization, not chronic prescribing volume. Each administration requires coordination among the ordering physician, radiopharmacy, imaging facility, and isotope supplier.[1]

What patents protect gallium citrate Ga 67?

Gallium citrate Ga 67 has little practical patent protection. The underlying radiopharmaceutical concept and the principal clinical uses date back several decades. Any early composition, use, or manufacturing patents would have expired long ago.

No commercially relevant modern patent estate is generally associated with:

• Gallium-67 citrate as an active diagnostic agent
• Conventional intravenous gallium citrate formulations
• Standard SPECT imaging uses
• The basic production of gallium-67 for routine diagnostic use

The product is therefore exposed to regulatory, manufacturing, and supply-chain barriers rather than patent barriers.

Are there formulation patents for gallium citrate Ga 67?

The conventional formulation is a sterile injectable solution containing gallium-67 citrate and excipients suitable for intravenous use. Its commercial defensibility does not rest on a long-lived formulation patent.

A manufacturer could obtain limited protection for a new delivery system, generator configuration, synthesis process, imaging protocol, or combination diagnostic method. Such rights would protect a specific improvement, not the established gallium citrate Ga 67 product itself. No widely recognized, commercially decisive formulation patent controls the standard product.

Are there method-of-use patents for gallium citrate Ga 67?

The conventional indications are old and generally not protected by enforceable exclusivity. New method-of-use claims could theoretically cover a narrowly defined imaging application, patient subgroup, or combination with another diagnostic modality, but these would not create broad market exclusivity for gallium citrate Ga 67.

When does gallium citrate Ga 67 lose exclusivity?

Gallium citrate Ga 67 has effectively lost conventional market exclusivity. The relevant patent terms are historical, and the product competes as a mature diagnostic radiopharmaceutical.

The more important exclusivity question is regulatory market access rather than patent expiration. A supplier can retain commercial share through:

• Manufacturing authorization
• FDA-compliant facilities
• Reliable isotope procurement
• Nuclear-pharmacy distribution
• Hospital and radiology contracts
• Consistent product availability
• Reimbursement acceptance

Those advantages can create practical customer retention without creating legal exclusivity.

What is the Orange Book status of gallium citrate Ga 67?

The Orange Book question requires product-specific review of current FDA listing data because radiopharmaceutical listings, abbreviated applications, and marketing status can change. Gallium citrate Ga 67 does not have a commercially important, widely recognized Orange Book patent listing comparable with branded small-molecule products such as oncology tablets or specialty injectables.

The product's competitive position is not based on listed patents or a remaining Hatch-Waxman exclusivity period. Paragraph IV litigation is therefore not a central commercial risk.

Are there Paragraph IV challenges to gallium citrate Ga 67?

No major, commercially significant Paragraph IV challenge is broadly associated with gallium citrate Ga 67. The product is old, injectable, radioactive, and operationally specialized. A potential competitor would generally face more practical obstacles from isotope supply, facility qualification, distribution, and limited demand than from an active patent challenge.

For a generic or alternate manufacturer, the principal questions are:

1. Whether an FDA-approved product can be manufactured consistently.
2. Whether gallium-67 can be sourced at commercially viable cost.
3. Whether radiopharmacies will stock the product.
4. Whether hospitals retain enough utilization to justify scheduled supply.
5. Whether reimbursement supports the full production and delivery chain.

How large is the gallium citrate Ga 67 market?

Public sources do not provide a reliable standalone global revenue figure for gallium citrate Ga 67. Manufacturers generally report radiopharmaceutical or nuclear-medicine revenue at broader portfolio levels rather than disclosing sales for this individual product.

The market is small relative to major pharmaceutical categories and is structurally constrained by declining utilization. Demand is concentrated in hospitals, academic medical centers, nuclear-medicine departments, oncology practices, and facilities managing complex infection or inflammation cases.

The market is affected by four forces:

Market force	Effect on gallium citrate Ga 67
PET substitution	Reduces routine use, particularly in oncology
SPECT infrastructure	Preserves access where PET is unavailable
Isotope supply	Creates production and scheduling risk
Clinical niche demand	Supports residual use in infection and inflammation

Gallium-67 retains value where PET is unavailable, where a clinician needs delayed inflammatory imaging, or where local practice patterns continue to support the product. Its use is less defensible in routine lymphoma imaging, where FDG PET/CT has become a preferred modality in many clinical settings.

How does gallium citrate Ga 67 compare with competing diagnostic agents?

Gallium-67 versus fluorodeoxyglucose F 18

FDG PET/CT has stronger oncology utility, higher resolution, faster workflow, and broad reimbursement support in many cancer indications. These advantages have displaced gallium-67 in numerous lymphoma and tumor-imaging applications.

Gallium-67 can remain relevant when:

• PET is unavailable
• Infection or inflammation is the principal diagnostic question
• Delayed imaging is clinically useful
• Local expertise and equipment favor SPECT
• A specific historical protocol remains in place

Gallium-67 versus gallium-68 agents

Gallium-68 is a different isotope with a half-life of approximately 68 minutes and is used in targeted PET agents such as gallium-68 DOTATATE and gallium-68 PSMA products. Gallium-68 agents have substantially different chemistry, indications, and imaging characteristics.

Gallium-68 PET products compete with gallium-67 citrate indirectly by expanding molecular imaging and replacing older SPECT workflows. They are not interchangeable products.

Gallium-67 versus tagged white-blood-cell imaging

Indium-111 or technetium-99m labeled leukocyte imaging can be used for selected infection and inflammation evaluations. The choice depends on clinical indication, availability, imaging protocol, and institutional expertise.

Competitive comparison

Attribute	Gallium citrate Ga 67	FDG F 18 PET	Gallium-68 targeted PET	Tagged WBC imaging
Main modality	SPECT or planar imaging	PET/CT	PET/CT	SPECT or planar imaging
Oncology strength	Legacy and selected uses	Broad	Target-specific	Limited
Infection imaging	Established niche	Increasing use	Limited by target	Established niche
Imaging schedule	Often delayed, up to 72 hours	Usually same day	Usually same day	Often delayed
Patent position	Mature, largely unprotected	Product- and use-specific	Active product-level IP possible	Product and process dependent
Growth outlook	Declining or stable niche	Expanding in many indications	Expanding in selected fields	Stable niche

What manufacturing and supply barriers affect gallium citrate Ga 67?

Gallium-67 is produced in cyclotrons through irradiation of enriched targets, followed by radiochemical processing and quality control. The product requires specialized infrastructure and cannot be manufactured in a conventional pharmaceutical plant.

Key barriers include:

• Access to suitable cyclotron capacity
• Availability and cost of enriched target material
• Radioactive material licensing
• Radiochemical purification
• Sterile injectable production
• Short distribution windows relative to isotope decay
• Nuclear-pharmacy logistics
• Qualified personnel and radiation controls
• Demand forecasting for scheduled production

The 78-hour half-life is longer than that of many PET isotopes, but radioactive decay still creates inventory loss and complicates long-distance distribution. A supplier must balance batch size against expected orders. Underproduction causes shortages; overproduction causes radioactive product loss.

These constraints can protect incumbent suppliers operationally, but they do not produce the pricing power associated with patented pharmaceuticals. Hospital customers can switch to competing imaging methods rather than accept materially higher prices.

What litigation affects gallium citrate Ga 67?

No major patent litigation or settlement agreement is broadly associated with the established gallium citrate Ga 67 market. Litigation risk is more likely to arise from:

• Product liability
• Manufacturing quality
• Radiation-handling incidents
• Contract disputes
• Regulatory compliance
• Supply interruptions
• Reimbursement disputes

The absence of prominent patent litigation reflects the product's age and weak remaining exclusivity position.

What is the financial trajectory for gallium citrate Ga 67?

The financial trajectory is mature and declining, with limited prospects for substantial revenue growth. Product-specific revenue, gross margin, and operating profit are generally not separately disclosed by suppliers. Financial analysis therefore must rely on utilization, competitive substitution, reimbursement, and supply economics.

Revenue drivers

Revenue is supported by:

• Residual oncology imaging
• Infection and inflammation workups
• SPECT capacity in hospitals without PET access
• Existing physician familiarity
• Supply continuity in markets with few vendors

Revenue pressures

Revenue is pressured by:

• FDG PET/CT substitution
• Expansion of gallium-68 PET
• Greater use of CT, MRI, and labeled leukocyte imaging
• Declining use of older lymphoma protocols
• Low procedure volume
• Radioactive decay and inventory waste
• Reimbursement pressure
• Hospital consolidation and centralized purchasing

The product can remain profitable for a specialized supplier if production is efficient and distribution is concentrated. Profitability becomes vulnerable when volume falls below the minimum batch size required to justify cyclotron operation, quality-control testing, packaging, and delivery.

What generic launch risks exist for gallium citrate Ga 67?

A new entrant would not face a conventional patent cliff. The principal launch risk is commercial viability.

Risk	Commercial consequence
Small addressable market	Limited volume to recover development and facility costs
Isotope decay	Product loss if orders are canceled or delayed
Hospital substitution	Customers may choose PET or other imaging
Regulatory compliance	High cost of radioactive sterile manufacturing
Supply variability	Inability to maintain dependable delivery
Reimbursement	Weak economics despite FDA approval
Low switching incentive	Existing nuclear pharmacies may retain incumbent supply

A generic launch could succeed in a supply-constrained region or through a radiopharmacy with existing cyclotron and distribution assets. It would be less attractive as a standalone investment requiring new infrastructure.

Which companies compete in the gallium citrate Ga 67 market?

The commercial supply chain has historically included specialized nuclear-medicine manufacturers and radiopharmaceutical distributors, including organizations associated with Curium, Mallinckrodt, Cardinal Health, and regional nuclear pharmacies. Product ownership, marketing status, and distribution arrangements can vary by jurisdiction and time.

Competition should be assessed at three levels:

1. Approved gallium-67 citrate suppliers.
2. Nuclear pharmacies and radiopharmaceutical distributors.
3. Alternative imaging providers using FDG PET, gallium-68 PET, labeled leukocytes, MRI, or CT.

The third category is strategically more important than direct product competition because substitution is the main long-term threat.

What licensing deals affect gallium citrate Ga 67?

No major recent licensing transaction is widely associated with the conventional gallium citrate Ga 67 product. Commercial arrangements are more likely to involve:

• Radiopharmaceutical distribution
• Contract manufacturing
• Cyclotron access
• Regional supply agreements
• Nuclear-pharmacy services
• Hospital purchasing contracts

Licensing value is limited because the conventional product has no substantial patent exclusivity. Transaction value is more likely to reflect manufacturing capacity, regulatory approvals, customer access, and isotope supply than intellectual property.

Key Takeaways

• Gallium citrate Ga 67 is a legacy FDA-approved diagnostic radiopharmaceutical.
• Its remaining use is concentrated in selected infection, inflammation, and oncology imaging.
• The product has no meaningful modern patent moat and no relevant biosimilar pathway.
• Paragraph IV litigation and patent settlements are not central market risks.
• FDG PET/CT and gallium-68 PET products are the principal long-term competitive pressures.
• Publicly reported product-specific revenue is generally unavailable.
• The market is small, mature, supply-sensitive, and structurally declining.
• Manufacturing barriers remain significant because of isotope production, sterile processing, licensing, and radioactive logistics.
• A new entrant would face commercial-scale and reimbursement risks rather than a conventional patent cliff.
• The strongest remaining value lies in reliable supply to facilities that lack PET access or retain established gallium-67 clinical protocols.

FAQs

Is gallium citrate Ga 67 still commercially available?

It can remain available through specialized radiopharmaceutical suppliers and nuclear pharmacies, but availability is jurisdiction-specific and may vary with production schedules, isotope supply, and local demand.

Is gallium citrate Ga 67 the same as gallium-68 DOTATATE?

No. Gallium-67 citrate is an older SPECT radiopharmaceutical. Gallium-68 DOTATATE is a targeted PET agent used primarily for somatostatin-receptor imaging.

Does gallium citrate Ga 67 have an active patent?

The established product is generally viewed as an off-patent diagnostic radiopharmaceutical. Any new patent would need to cover a specific improvement, manufacturing process, delivery system, or narrow imaging method.

Can a generic manufacturer launch gallium citrate Ga 67?

A manufacturer could pursue an approved competing product, but the economic case depends on cyclotron access, radioactive sterile manufacturing, radiopharmacy distribution, reimbursement, and sufficient demand.

Is gallium citrate Ga 67 used for cancer diagnosis?

Yes. It has historical and selected current use in lymphoma and other tumors, but FDG PET/CT has replaced it in many routine oncology imaging settings.

References

1. U.S. Food and Drug Administration. (n.d.). Gallium citrate Ga 67 injection prescribing information. FDA/DailyMed labeling repository.

2. National Cancer Institute. (n.d.). Gallium scan. National Cancer Institute.

3. International Atomic Energy Agency. (2015). Cyclotron produced radionuclides: Guidance on facility design and production. IAEA.

4. Society of Nuclear Medicine and Molecular Imaging. (2018). Procedure standard for gallium-67 scintigraphy. SNMMI.

5. Centers for Medicare & Medicaid Services. (n.d.). Medicare Physician Fee Schedule and radiology payment policies. CMS.