Gallium citrate ga-67 - Generic Drug Details

What are the generic sources for gallium citrate ga-67 and what is the scope of freedom to operate?

Gallium citrate ga-67 is the generic ingredient in two branded drugs marketed by Curium, Ge Healthcare, and Lantheus Medcl, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for gallium citrate ga-67

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	9
Patent Applications:	140
What excipients (inactive ingredients) are in gallium citrate ga-67?	gallium citrate ga-67 excipients list
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
Rahul Aggarwal	Phase 2
Merck Sharp & Dohme Corp.	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
Ge Healthcare	GALLIUM CITRATE GA 67	gallium citrate ga-67	INJECTABLE;INJECTION	017700-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	NEOSCAN	gallium citrate ga-67	INJECTABLE;INJECTION	017655-001	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
Curium	GALLIUM CITRATE GA 67	gallium citrate ga-67	INJECTABLE;INJECTION	018058-001	Approved Prior to Jan 1, 1982	BS	RX	No	No

Last updated: September 3, 2026

ecutive summary: Gallium citrate Ga-67 is a mature diagnostic radiopharmaceutical with declining commercial relevance. Its clinical use has contracted as FDG-PET, gallium-68 PET agents, labeled leukocytes, and other targeted imaging methods displaced much of the historical demand. The product has limited patent value, no meaningful conventional Orange Book exclusivity profile, and no publicly reported product-level revenue. Its remaining commercial value is concentrated in legacy SPECT imaging, infection and inflammation workups, and institutions without ready access to newer PET platforms. Financial performance is shaped more by reactor and cyclotron supply, nuclear-pharmacy logistics, reimbursement, and manufacturing scale than by intellectual-property protection.

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

What is Gallium Citrate Ga-67 and how is it used?

Gallium citrate Ga-67 injection is a diagnostic radiopharmaceutical containing radioactive gallium-67. It is administered intravenously and localizes in selected inflammatory, infectious, and malignant processes. The product is used with planar imaging or single-photon-emission computed tomography, rather than as a therapeutic drug.

The FDA label identifies clinical uses that include:

• Localization of sites of infection or inflammation.
• Imaging in selected patients with lymphoma.
• Evaluation of certain thoracic malignancies, including bronchogenic carcinoma.
• Assessment of disease when conventional diagnostic methods are inconclusive.

Gallium-67 has a physical half-life of approximately 78 hours. Its principal imaging emissions include photons at approximately 93, 185, 300, and 393 keV. The relatively long half-life permits delayed imaging, often over several days, but also creates radiation-dose, scheduling, and waste-management disadvantages compared with shorter-lived or PET-based alternatives. [1]

The product is distinct from gallium-68 radiopharmaceuticals. Gallium-68 is a positron-emitting isotope used in PET agents such as gallium-68 dotatate and gallium-68 gozetotide. The commercial growth of gallium-68 PET has not translated into growth for gallium citrate Ga-67 because the two isotopes support different imaging technologies and clinical applications.

What is the FDA regulatory status of Gallium Citrate Ga-67?

Gallium citrate Ga-67 is an FDA-approved diagnostic radiopharmaceutical, not an investigational product. Its approval predates the current wave of PET radiopharmaceutical development. The product is generally supplied as a sterile injectable solution for intravenous administration and requires radiopharmacy handling.

The regulatory profile is defined by several characteristics:

Regulatory element	Gallium citrate Ga-67 position
FDA status	Approved diagnostic radiopharmaceutical
Route	Intravenous injection
Imaging modality	Planar imaging and SPECT
Active radioactive component	Gallium-67
Therapeutic indication	None
Typical product type	Short commercial shelf-life radiopharmaceutical
Administration setting	Hospital, imaging center, or nuclear pharmacy
Key regulatory burden	Radioactive-material handling, quality control, sterility, dose calibration, distribution

The product’s commercial availability can vary by manufacturer, radiopharmacy, isotope supplier, and region. Radiopharmaceutical labels and availability notices must be reviewed separately from the existence of the original FDA approval. FDA approval does not guarantee continuous commercial supply.

What is the Orange Book status of Gallium Citrate Ga-67?

Gallium citrate Ga-67 has little conventional Orange Book value. Diagnostic radiopharmaceuticals are not typically protected by the same patent-and-exclusivity structure that supports branded small-molecule products such as chronic medicines.

The relevant commercial observations are:

1. The product is mature and broadly characterized.
2. No current blockbuster-style composition-of-matter patent estate is associated with gallium citrate Ga-67.
3. Any historical product patents would generally have expired or become commercially immaterial.
4. Product availability depends on manufacturing authorization, radiopharmaceutical quality systems, isotope supply, and distribution.
5. The main competitive barrier is operational execution rather than statutory exclusivity.

The absence of a meaningful Orange Book barrier does not eliminate regulatory or commercial hurdles for a competing supplier. A new entrant would still need an FDA-compliant product, validated production and quality-control processes, licensed radioactive-material operations, reliable isotope supply, and a distribution network capable of meeting short dating requirements.

When does Gallium Citrate Ga-67 lose exclusivity?

Gallium citrate Ga-67 effectively lost any meaningful exclusivity years ago. The active diagnostic concept, isotope, and citrate formulation are longstanding technologies. A current entrant would not face a practical patent cliff comparable to a branded therapeutic drug.

Exclusivity category	Current commercial assessment
New chemical entity exclusivity	Not relevant
Orphan-drug exclusivity	Not identified as a current commercial driver
Pediatric exclusivity	Not relevant
Patent term extension	No meaningful current role identified
Composition-of-matter patent	No active commercial barrier identified
Formulation patent	No active commercial barrier identified
Method-of-use patent	No material current barrier identified
Market protection	Operational and regulatory, not patent-based

A new supplier could compete through an approved equivalent product or through manufacturing and distribution advantages. The critical question is not when a patent expires. It is whether demand is large enough to justify production, quality systems, isotope procurement, and nuclear-pharmacy distribution.

What patents protect Gallium Citrate Ga-67?

No active, commercially significant patent estate is apparent for gallium citrate Ga-67 as a conventional diagnostic product. The underlying technology is old, and the product’s value does not depend on a proprietary molecular structure.

Formulation patents

Gallium citrate Ga-67 is a relatively simple radiopharmaceutical formulation. Potential formulation elements include gallium-67, citrate, water for injection, pH control, and product-specific stabilizing or preservative conditions. These elements are unlikely to create durable exclusivity when disclosed in an established FDA label and compendial or industry practice.

No current formulation patent has been identified as a material barrier to competition.

Method-of-use patents

Historical use claims for detecting infection, inflammation, lymphoma, or certain malignancies are broad clinical concepts. Those uses are not associated with a current, commercially meaningful exclusivity position for gallium citrate Ga-67.

No active method-of-use patent has been identified that would materially restrict routine use of the product.

Manufacturing and isotope-supply rights

The stronger barriers are manufacturing-related:

• Access to gallium-67 production capacity.
• Reactor or cyclotron scheduling.
• Radiochemical separation and purification.
• Sterile injectable production.
• Radioassay and radionuclidic-purity testing.
• Licensed handling and transportation.
• Dose calibration and delivery before radioactive decay materially reduces activity.

These barriers can limit competition even when patents do not. They are infrastructure constraints, not exclusivity rights.

Are there Paragraph IV challenges to Gallium Citrate Ga-67?

No material Paragraph IV litigation pattern is associated with gallium citrate Ga-67. Paragraph IV litigation is primarily relevant to abbreviated new drug applications that challenge listed patents for branded products. Gallium citrate Ga-67 does not present the typical active-patent profile that drives repeated ANDA challenges.

The more likely regulatory pathway for a competing product would involve an application demonstrating pharmaceutical quality, radiochemical identity, sterility, strength, purity, stability, and clinical utility under the applicable FDA framework. The absence of Paragraph IV activity reflects the product’s maturity and limited patent protection.

What litigation and settlement agreements affect Gallium Citrate Ga-67?

No major, publicly prominent patent litigation or branded-generic settlement agreement has been identified for gallium citrate Ga-67. The product’s risk profile is therefore different from high-revenue oncology drugs or specialty medicines with dense formulation and method-of-use portfolios.

Potential disputes would more likely concern:

• Manufacturing compliance.
• Product quality or sterility.
• Radioactive-material transportation.
• Supply interruptions.
• Contract manufacturing.
• Reimbursement and billing.
• Product liability or radiation-handling issues.

These issues can affect supply and economics without creating a traditional patent settlement timeline.

How strong is the patent estate for Gallium Citrate Ga-67?

The patent estate is weak from a commercial-protection standpoint. Its value is best classified as low.

Patent-strength factor	Assessment
Core composition protection	Weak or absent
Formulation protection	Weak
Method-of-use protection	Weak
Device or delivery protection	Not central to product
Manufacturing know-how	Potentially useful but difficult to monetize as exclusivity
Trade-secret value	Moderate for process execution and quality systems
Freedom to operate	Generally favorable for mature product concepts
Patent-driven pricing power	Minimal

The product can retain commercial value without patent strength because radiopharmaceutical supply chains are specialized. A supplier with reliable isotope access, nationwide nuclear-pharmacy coverage, and strong quality performance may maintain a defensible business position. That position is vulnerable to demand erosion and substitution by PET-based imaging.

How does Gallium Citrate Ga-67 compare with competing imaging agents?

Gallium citrate Ga-67 competes against diagnostic methods rather than only chemically similar products.

Imaging option	Primary advantage	Primary limitation relative to Ga-67
FDG-PET/CT	High sensitivity and broad oncology use; faster workflows	Higher capital and operating requirements
Gallium-68 PET agents	Targeted molecular imaging and high-resolution PET	Indication-specific; isotope and agent access vary
Indium-111-labeled leukocytes	Useful for selected infection evaluations	Complex labeling and longer procedures
Technetium-99m agents	Broad nuclear-medicine availability and lower operating burden	Less specific for some malignancies and infections
MRI and CT	High anatomic detail and broad availability	May not provide equivalent functional or inflammatory information
Tagged white blood cell imaging	Established niche for infection	Labor-intensive and operationally complex

FDG-PET has been the principal structural threat in oncology and many infection-related applications. PET offers improved spatial resolution, faster imaging, and more integrated anatomical assessment when paired with CT. Gallium citrate Ga-67 remains relevant in selected cases where delayed inflammatory imaging is useful or PET access is limited. [2,3]

What is the market size for Gallium Citrate Ga-67?

A reliable standalone global market size is not publicly established. Public company filings generally report broader nuclear-medicine, radiopharmaceutical, or imaging portfolios rather than revenue for gallium citrate Ga-67 alone.

The market should be viewed as a declining legacy segment with these characteristics:

• Low product differentiation.
• Limited pricing power.
• Small order sizes relative to major PET portfolios.
• Regional supply dependence.
• High logistics sensitivity because of radioactive decay.
• Demand concentrated in hospitals and imaging centers.
• Substitution pressure from PET and modern infection-imaging methods.

A conventional pharmaceutical market model based on prescription volume and branded net sales is poorly suited to Ga-67. The product is purchased through radiopharmacy and institutional channels. Revenue depends on administered doses, isotope activity at delivery, reimbursement, wastage, and the ability to consolidate production and distribution.

What is the financial trajectory of Gallium Citrate Ga-67?

The financial trajectory is structurally negative, with any remaining revenue likely concentrated in a narrow and stable niche.

Historical phase

Gallium-67 was historically used for lymphoma, thoracic malignancy, fever of unknown origin, sarcoidosis, and infection imaging. It had a larger role before widespread PET deployment.

Transition phase

The market contracted as FDG-PET expanded in oncology and as CT, MRI, tagged leukocyte imaging, and targeted PET agents gained clinical acceptance. The shift reduced routine use and narrowed the addressable market.

Current phase

Current economics are driven by:

• Replacement demand from legacy users.
• Regional shortages or limited PET capacity.
• Institutional protocols that retain Ga-67.
• Availability of isotope production.
• Nuclear-pharmacy route density.
• Reimbursement for the underlying imaging procedure.

Product-level financial data are generally unavailable. A reasonable commercial assessment is that Ga-67 contributes limited revenue relative to leading PET agents, therapeutic radiopharmaceuticals, and high-volume technetium products. Its gross margin can be pressured by fixed quality and distribution costs spread over a declining number of doses.

Which companies are associated with Gallium Citrate Ga-67 supply?

Supply has historically involved large radiopharmaceutical manufacturers, nuclear pharmacies, isotope producers, and hospital-based radiopharmacies. Brand and supplier availability can change over time because of acquisitions, discontinuations, manufacturing transfers, and local distribution decisions.

The commercially relevant supplier categories are:

1. National radiopharmaceutical manufacturers.
2. Regional nuclear pharmacies.
3. Isotope producers and reactor operators.
4. Hospital radiopharmacies.
5. Contract manufacturers with sterile radioactive-product capability.

Supplier concentration can create localized market power even without patent protection. A hospital may have few practical alternatives if only one qualified supplier can deliver calibrated Ga-67 doses within the usable time window.

What generic entry risks exist for Gallium Citrate Ga-67?

Generic-entry risk is high in legal terms because patent barriers are limited. Commercial entry risk is also high because the market is mature, declining, and operationally demanding.

A new entrant would need to overcome:

• Small and geographically dispersed demand.
• Radioactive decay during transport.
• High compliance costs.
• Need for validated sterile production.
• Limited ability to build inventory.
• Competition from entrenched radiopharmacy networks.
• Clinical substitution by PET and other modalities.
• Variable reimbursement and institutional utilization.

The most plausible entrant would be an established radiopharmaceutical company adding Ga-67 to an existing infrastructure. A conventional generic-drug company without nuclear-medicine capabilities would face a weaker business case.

What generic launch scenarios are plausible?

Limited regional launch

A regional nuclear pharmacy could supply selected hospitals with scheduled doses. This model limits distribution costs but cannot capture broad national volume.

Portfolio-based launch

A major radiopharmaceutical supplier could maintain Ga-67 as part of a wider portfolio containing technetium products, FDG, gallium-68 agents, and therapeutic radiopharmaceuticals. Cross-selling and shared infrastructure would improve economics.

Contract-manufacturing launch

A sponsor could outsource production to a qualified nuclear manufacturer. This reduces capital expenditure but creates dependence on production slots, quality agreements, and isotope availability.

Discontinuation scenario

If demand falls below minimum efficient scale or isotope supply becomes unreliable, the product could be discontinued in a region even while remaining FDA-approved. This is a realistic risk for mature radiopharmaceuticals with declining utilization.

What geographic markets remain commercially relevant?

Ga-67 demand is most defensible in markets with:

• Established SPECT infrastructure.
• Limited PET availability.
• Large hospital nuclear-medicine departments.
• Local isotope production or dependable import channels.
• Reimbursement for infection and inflammation imaging.
• Clinical protocols that retain gallium scanning.

The United States remains commercially relevant because of its installed nuclear-medicine base and FDA-approved product history. European, Asian, and Latin American demand varies substantially by country, imaging capacity, local approvals, isotope access, and reimbursement. Geographic coverage is therefore more operational than patent-driven.

What manufacturing and intellectual-property barriers affect the product?

Manufacturing barriers exceed intellectual-property barriers.

Critical technical controls include:

• Radionuclidic identity and purity.
• Radiochemical purity.
• Sterility and endotoxin control.
• Accurate activity measurement.
• Stability through the labeled expiration period.
• Container integrity.
• Dose calibration at dispatch and administration.
• Compliance with radioactive-material transport rules.

Gallium-67 production depends on specialized nuclear infrastructure. A supply interruption can result from reactor maintenance, target-irradiation problems, radiochemical processing failures, transportation restrictions, or shortages of qualified personnel.

Trade secrets may improve yield, purity, scheduling, or operational efficiency. They are unlikely to provide durable market exclusivity comparable to an issued pharmaceutical patent.

How does Gallium Citrate Ga-67 compare with gallium-68 PET agents?

Gallium-68 agents have stronger growth characteristics because they support targeted PET imaging in indications such as neuroendocrine tumors and prostate cancer, depending on the agent. Their value is linked to molecular targeting, high-resolution PET, and expanding theranostic platforms.

Attribute	Gallium citrate Ga-67	Gallium-68 PET agents
Isotope	Ga-67	Ga-68
Imaging	Planar/SPECT	PET/CT or PET/MRI
Half-life	About 78 hours	About 68 minutes
Clinical positioning	Legacy infection, inflammation, and selected oncology imaging	Targeted molecular imaging
Commercial trend	Declining or niche	Expanding in selected indications
Patent potential	Low for basic citrate product	Higher for ligands, formulations, kits, and methods
Supply model	Reactor/cyclotron and radiopharmacy dependent	Generator or cyclotron dependent
Pricing power	Limited	Higher for proprietary targeted agents

The success of gallium-68 products may accelerate, rather than reverse, the decline of gallium citrate Ga-67 by shifting clinical investment toward PET infrastructure and targeted radiopharmaceutical portfolios.

Key Takeaways

• Gallium citrate Ga-67 is an FDA-approved diagnostic radiopharmaceutical used primarily for selected infection, inflammation, lymphoma, and thoracic imaging applications.
• Its market is mature and declining because FDG-PET, gallium-68 PET, MRI, CT, and other imaging methods have displaced routine use.
• No meaningful current patent estate, Orange Book exclusivity, Paragraph IV litigation, or settlement framework is associated with the product.
• The main barriers are isotope supply, sterile radioactive manufacturing, quality systems, transportation, and nuclear-pharmacy distribution.
• Product-level revenue is not publicly reported, but commercial value is likely modest relative to modern PET agents and therapeutic radiopharmaceuticals.
• The strongest remaining business model is portfolio-based supply by an established radiopharmaceutical manufacturer or nuclear-pharmacy network.
• Generic entry is legally feasible but commercially difficult because demand is limited, declining, and geographically fragmented.
• Gallium-68 PET agents have substantially stronger growth and patent potential than gallium citrate Ga-67.

FAQs

Is Gallium Citrate Ga-67 still FDA approved?

Yes. Gallium citrate Ga-67 remains an FDA-approved diagnostic radiopharmaceutical, although commercial availability can vary by supplier and region. [1]

Is Gallium Citrate Ga-67 a cancer treatment?

No. It is an imaging agent. It does not treat cancer, infection, or inflammation.

Is gallium-67 the same as gallium-68?

No. Gallium-67 is primarily used for SPECT or planar imaging, while gallium-68 is used in PET radiopharmaceuticals. Their half-lives, imaging physics, clinical uses, and commercial markets differ.

Can hospitals substitute FDG-PET for Gallium Citrate Ga-67?

In many oncology and selected inflammatory-imaging settings, FDG-PET can substitute for Ga-67. The appropriate modality depends on the indication, clinical protocol, availability, reimbursement, and patient-specific factors. [2,3]

Does Gallium Citrate Ga-67 have biosimilar risk?

No. Biosimilar regulation applies to biological products. Gallium citrate Ga-67 is a radioactive diagnostic small-molecule radiopharmaceutical and is not a biologic.

References

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

2. Jadvar, H., & Alavi, A. (2009). Gallium-67 and gallium-68 in nuclear medicine. Seminars in Nuclear Medicine, 39(5), 359-368.

3. Love, C., Palestro, C. J., & others. (2013). Nuclear medicine imaging of infection and inflammation. Radiologic Clinics of North America, 51(5), 839-858.

4. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

5. International Atomic Energy Agency. (n.d.). Nuclear medicine resources and radioisotope production guidance. IAEA.