When do the GALLIUM CITRATE GA 67 patents expire, and when will GALLIUM CITRATE GA 67 go generic?

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ge Healthcare	GALLIUM CITRATE GA 67	gallium citrate ga-67	INJECTABLE;INJECTION	017700-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lantheus Medcl	GALLIUM CITRATE GA 67	gallium citrate ga-67	INJECTABLE;INJECTION	017478-001	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

Last updated: July 31, 2026

Gallium citrate Ga 67 is a legacy diagnostic radiopharmaceutical used primarily for imaging infection, inflammation, and selected tumors. Its investment profile is weak as a standalone pharmaceutical asset. The product has no meaningful remaining market exclusivity, limited patent protection, an aging clinical role, and competition from fluorodeoxyglucose F-18 PET, white-blood-cell imaging, MRI, CT, and newer targeted radiopharmaceuticals.

Commercial value is concentrated in manufacturing licenses, cyclotron and radiopharmacy infrastructure, hospital supply contracts, and dependable isotope distribution. The active ingredient itself offers little intellectual-property protection.

What is Gallium Citrate Ga 67 used for?

Gallium citrate Ga 67 is an injectable diagnostic radiopharmaceutical containing the radioactive isotope gallium-67. The FDA label identifies its use for localization of infection or inflammatory lesions and for imaging certain malignant tumors, including lymphoma and other tumors with gallium-avid behavior (U.S. Food and Drug Administration [FDA], n.d.-a).

Gallium-67 has a physical half-life of approximately 78 hours. It emits gamma radiation suitable for planar imaging and single-photon emission computed tomography. The isotope is generally produced in a cyclotron and incorporated into a sterile injectable product.

Attribute	Gallium citrate Ga 67
Active component	Gallium-67 citrate
Product type	Diagnostic radiopharmaceutical
Primary modality	Gamma-camera imaging and SPECT
Physical half-life	Approximately 78 hours
Main uses	Infection, inflammation, lymphoma and selected tumors
Administration	Intravenous injection
Manufacturing model	Cyclotron isotope production, radiochemical synthesis, sterile filling
Therapeutic effect	None; diagnostic imaging only
FDA pathway	Legacy approved radiopharmaceutical product
Biosimilar exposure	None
Current IP moat	Minimal

The product differs from gallium-68 agents such as gallium-68 DOTATATE and gallium-68 PSMA products. Gallium-68 is a positron-emitting isotope used in PET imaging and is attached to targeting molecules. Gallium citrate Ga 67 is a different isotope, a different chemical product, and a different clinical platform.

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

Gallium citrate Ga 67 has a long-standing FDA-approved diagnostic indication. Its regulatory status is tied to the specific product sponsor, manufacturer, and National Drug Code rather than to a single global commercial franchise.

The product is generally regulated as an approved radiopharmaceutical injection. FDA product information identifies radiopharmaceutical-specific requirements involving radionuclide purity, radiochemical purity, sterility, assay, labeling, and expiration dating (FDA, n.d.-a; FDA, n.d.-b).

What FDA exclusivity remains?

No meaningful period of FDA new-drug exclusivity remains for Gallium Citrate Ga 67. The product was approved decades ago, so any original five-year new chemical entity exclusivity and associated regulatory exclusivity periods have expired.

The product is not a biologic and does not receive the 12-year reference-product exclusivity applicable to biologics. It also does not have biosimilar exclusivity issues.

Exclusivity category	Current position
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	No current relevant protection identified
Pediatric exclusivity	No current relevant protection identified
Biologic reference-product exclusivity	Not applicable
Qualified infectious-disease exclusivity	Not applicable
Patent-term extension	No economically meaningful current protection
Regulatory moat	Low

What patents protect Gallium Citrate Ga 67?

The core composition and clinical use of Gallium Citrate Ga 67 are not protected by enforceable modern patents in the United States. Any patents covering the original isotope formulation, early imaging applications, or legacy manufacturing methods would have expired long ago.

The commercial protection that remains is operational rather than patent-based. It can include:

FDA-approved manufacturing controls
Cyclotron access
Radioisotope production capacity
Radiochemical synthesis know-how
Sterile injectable manufacturing
Qualified supplier and hospital contracts
Distribution systems capable of handling radioactive products
Site-specific state and federal licenses

These barriers can limit entry even when patent barriers do not exist. They do not create durable exclusivity equivalent to a composition-of-matter patent.

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

The Orange Book is relevant only to approved products and any patents submitted for listing by the applicable NDA holder. Gallium citrate Ga 67 does not present the profile of a modern branded product with a significant Orange Book patent estate.

No commercially material active composition, formulation, or method-of-use patent should be assumed to protect the product. Investors should distinguish between an FDA-approved product listing and patent-listed exclusivity. An approved legacy radiopharmaceutical can remain commercially available without having enforceable Orange Book patents.

When does Gallium Citrate Ga 67 lose exclusivity?

Gallium Citrate Ga 67 lost its meaningful regulatory and patent exclusivity many years ago. There is no commercially relevant future loss-of-exclusivity date comparable to the patent cliffs associated with newer branded drugs.

Exclusivity event	Timing
Original FDA exclusivity	Expired decades ago
Original formulation patents	Expired decades ago
Current patent cliff	None of commercial significance
Generic or competing product risk	Ongoing and structurally high
Key commercial risk	Supply substitution and declining utilization

The relevant investment question is not when exclusivity ends. It is whether demand remains sufficient to support isotope production, sterile manufacturing, and distribution.

How many patents cover Gallium Citrate Ga 67?

No meaningful active patent estate is expected to cover the core product in the United States. Patent searches may identify historical patents involving gallium isotopes, tumor imaging, chelation chemistry, radiopharmaceutical preparation, or diagnostic methods. Those documents should not be treated as current barriers without confirming legal status, claim scope, jurisdiction, and ownership.

A patent directed to a broad radiopharmaceutical process may not cover a specific gallium citrate product. Conversely, a patent associated with gallium-68 targeting agents does not protect gallium citrate Ga 67.

Are formulation patents relevant?

Formulation protection is weak. Gallium citrate Ga 67 is a relatively established chemical product with a simple diagnostic purpose. Potential formulation variables include:

Citrate concentration
pH
Stabilizers
Radionuclidic purity
Radiochemical purity
Container closure
Sterility and endotoxin controls
Calibration and expiration dating

These variables can require validated manufacturing methods and regulatory documentation. They generally do not create long-lived patent protection for the product.

Are method-of-use patents relevant?

Method-of-use patents for gallium imaging in infection, inflammation, lymphoma, or other cancers would generally be old or difficult to enforce against a product used for a broad approved indication. The clinical use has been established for decades, limiting the practical value of new method claims unless they cover a narrow, novel imaging protocol or a specific patient population.

What generic entry risks exist for Gallium Citrate Ga 67?

Generic and alternative-product risk is high because the active diagnostic concept is mature and the product lacks meaningful patent protection. Entry is constrained by the economics and logistics of radioactive manufacturing rather than by intellectual property.

A potential competitor would need to establish:

A compliant source of gallium-67.
A validated radiochemical manufacturing process.
Sterile injectable production.
Quality-control testing for radionuclidic and radiochemical purity.
FDA approval or the applicable regulatory authorization.
Distribution before radioactive decay materially reduces usable inventory.
Hospital and radiology-department adoption.

The short effective shelf life creates a different competitive model from conventional generics. A low-cost manufacturer located far from customers may be less competitive than a higher-cost producer with reliable local delivery.

What generic launch scenarios are plausible?

Scenario	Commercial effect
New domestic approved supplier	Price competition and improved supply resilience
Regional radiopharmacy production	Local substitution with limited national impact
Manufacturing interruption	Temporary shortages and pricing support for remaining suppliers
Continued diagnostic substitution	Gradual volume decline
Hospital conversion to PET or alternative imaging	Structural demand erosion
Supply consolidation	Greater value for reliable producers despite weak IP

A generic launch would not necessarily eliminate incumbent revenue. Radiopharmaceutical purchasing is often influenced by delivery reliability, radiopharmacy relationships, regulatory history, and dose availability.

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

The patent estate is weak.

Patent factor	Assessment
Composition-of-matter protection	Expired
Core formulation protection	Expired or immaterial
Method-of-use protection	Weak and largely legacy
Manufacturing patents	Limited practical relevance
Orange Book leverage	Low
Freedom-to-operate risk	Generally low for the core product
Defensibility	Operational rather than legal
Investor conclusion	No patent-driven pricing power

The strongest barriers are regulatory and logistical. A manufacturer with licensed production, validated facilities, isotope access, and hospital distribution may have a defensible operating position, but the position is not equivalent to a protected branded pharmaceutical franchise.

What is the competitive landscape for Gallium Citrate Ga 67?

Gallium citrate Ga 67 competes with diagnostic technologies rather than only chemically equivalent products.

Direct and indirect competitors

F-18 FDG PET for oncology and selected inflammatory conditions
Tagged white-blood-cell imaging for infection
MRI for soft-tissue and osteomyelitis evaluation
CT for anatomical and infectious disease assessment
Bone scintigraphy using technetium-99m agents
Indium-111-labeled leukocyte imaging
Gallium-68 PET agents for neuroendocrine tumors and prostate cancer
Conventional clinical, microbiological, and anatomical diagnostic workflows

F-18 FDG PET has a major competitive advantage in many oncology settings because of greater availability, established reimbursement, higher image resolution, and broader clinical adoption. Gallium citrate Ga 67 can retain utility in selected infection and inflammatory imaging settings, particularly where PET access is limited or where a specific institutional protocol remains established.

The product may also benefit from supply gaps affecting alternative radiopharmaceuticals. That benefit is episodic rather than a durable growth driver.

How does Gallium Citrate Ga 67 compare with Gallium-68 radiopharmaceuticals?

Gallium-68 products have a stronger current growth profile because they are used with targeted ligands in PET imaging. Examples include gallium-68 DOTATATE for somatostatin receptor-positive neuroendocrine tumors and gallium-68 PSMA products for prostate cancer imaging.

Factor	Gallium citrate Ga 67	Gallium-68 targeted agents
Imaging	SPECT or planar gamma imaging	PET
Clinical targeting	Relatively nonspecific	Molecularly targeted
Image quality	Lower than PET	Higher
Half-life	Approximately 78 hours	Approximately 68 minutes
Production model	Cyclotron and distribution	Generator or cyclotron, often local production
Growth outlook	Mature to declining	Expanding in targeted oncology
IP potential	Low	Higher at ligand, kit, generator, and method levels
Investment profile	Infrastructure and supply	Product, platform, and clinical expansion

Confusing gallium citrate Ga 67 with gallium-68 targeted radiopharmaceuticals can produce materially incorrect market and patent conclusions.

Which companies are challenging or supplying Gallium Citrate Ga 67?

The relevant competitive set consists of radiopharmaceutical manufacturers, nuclear pharmacies, hospital systems, and isotope suppliers. Supplier participation can change by country and over time because of manufacturing discontinuations, facility changes, product shortages, and local licensing.

The market has historically included large radiopharmaceutical suppliers and specialized nuclear-medicine manufacturers. The commercial question is whether a company has current authorization, active production, and reliable distribution, not whether it once held a legacy product approval.

No major Paragraph IV litigation campaign is associated with the core Gallium Citrate Ga 67 market. The product’s age and weak patent estate reduce the incentive for branded-versus-generic patent litigation.

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

No material current patent litigation or settlement framework is central to the product’s investment case. There is no evident branded patent thicket comparable to those surrounding high-value oncology drugs, biologics, inhaled products, or long-acting injectables.

Paragraph IV challenges are therefore not the principal risk variable. A competitor would more likely enter through regulatory approval, manufacturing capability, or a regional supply model than through a high-value patent challenge.

The absence of litigation should not be interpreted as evidence of a strong franchise. It reflects the product’s mature status and limited remaining patent value.

What are the revenue fundamentals for Gallium Citrate Ga 67?

Public company reporting rarely isolates Gallium Citrate Ga 67 revenue. The product is generally embedded within broader radiopharmaceutical, nuclear medicine, imaging, or hospital-supply segments.

The fundamental revenue drivers are:

Number of active imaging sites
Gallium-67 scan volume
Reimbursement rates
Alternative imaging adoption
Isotope and cyclotron costs
Sterile manufacturing utilization
Distribution radius
Product shortages and supplier exits
Hospital protocol preferences

The revenue outlook is best characterized as mature and niche. A producer may generate attractive contribution margins during supply shortages or in a region with limited competition. Sustained high growth is difficult to support without a new indication, a major supply disruption among alternatives, or integration into a broader radiopharmaceutical platform.

What is the likely investment scenario?

Investment scenario	Probability profile	Fundamental implication
Standalone growth asset	Low	Mature demand and weak differentiation
Stable niche cash-flow product	Moderate	Possible with efficient production and reliable supply
Strategic add-on to radiopharmacy platform	More attractive	Shared infrastructure and distribution economics
Patent-driven valuation expansion	Very low	No material current IP moat
Supply-constrained pricing opportunity	Episodic	Depends on competitor outages
Long-term volume expansion	Low	Pressure from PET and alternative imaging

Gallium Citrate Ga 67 is more suitable for analysis as a component of a radiopharmaceutical manufacturing or nuclear-pharmacy platform than as an independent high-growth drug asset. Its value may lie in filling production capacity, maintaining customer relationships, or monetizing specialized regulatory and distribution infrastructure.

What manufacturing and IP barriers affect the product?

Manufacturing barriers are more important than patent barriers. Gallium-67 production requires access to appropriate target materials, cyclotron capacity, radiochemical processing, quality-control systems, and licensed radioactive-material handling.

The principal operating risks include:

Cyclotron downtime
Target-material supply interruptions
Radioisotope yield variability
Sterile-fill capacity constraints
Quality-control release delays
Transportation restrictions
Radioactive decay during shipment
State and federal licensing requirements
Limited hospital demand per delivery route

These barriers can support incumbent supply relationships. They can also reduce the economic attractiveness of entry because total addressable demand is limited.

What geographic coverage does Gallium Citrate Ga 67 have?

Commercial availability is geographically fragmented. Radiopharmaceutical distribution is constrained by radioactive decay, transport regulations, facility licensing, and local demand density.

The most defensible geographic positions are generally those with:

Nearby cyclotron or isotope production
Established nuclear pharmacies
Dense hospital networks
Qualified radiopharmaceutical distribution
Local reimbursement support
Long-standing nuclear-medicine protocols

A manufacturer with broad conventional pharmaceutical distribution may not have a comparable advantage in Gallium Citrate Ga 67. Local infrastructure can matter more than national sales scale.

Key Takeaways

Gallium Citrate Ga 67 is a legacy diagnostic radiopharmaceutical with no meaningful remaining market exclusivity.
Core composition, formulation, and traditional-use patents are expired or commercially immaterial.
Orange Book and Paragraph IV dynamics are not central to the investment case.
Biosimilar risk does not apply because the product is not a biologic.
Competition comes from F-18 FDG PET, MRI, CT, tagged white-blood-cell imaging, and newer gallium-68 PET agents.
Revenue is difficult to isolate publicly and is likely concentrated in niche radiopharmaceutical supply channels.
The product has more value as part of a radiopharmacy, isotope-production, or hospital-supply platform than as a standalone growth asset.
Operational reliability, geographic coverage, regulatory compliance, and cyclotron access are the main defenses.
A new supplier could enter without overcoming a substantial patent barrier, but manufacturing economics and radioactive distribution remain practical obstacles.
The long-term outlook is mature to declining, with episodic opportunities during supply shortages.

FAQs About Gallium Citrate Ga 67 Investment and Patent Risk

Is Gallium Citrate Ga 67 still FDA approved?

Yes. Gallium citrate Ga 67 has a legacy FDA-approved diagnostic use for imaging selected infections, inflammatory lesions, and tumors. Commercial availability depends on active product authorization and supplier production.

Does Gallium Citrate Ga 67 have a patent cliff?

No meaningful future patent cliff exists. The important exclusivity periods expired decades ago.

Can a generic company launch Gallium Citrate Ga 67?

Potentially, subject to FDA requirements, manufacturing validation, isotope access, sterility controls, and radioactive-product distribution. The main barrier is operational execution rather than patent ownership.

Is Gallium Citrate Ga 67 a biosimilar opportunity?

No. Gallium citrate Ga 67 is a small-molecule diagnostic radiopharmaceutical, not a biologic reference product.

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

No. Gallium citrate Ga 67 uses gallium-67 for gamma-camera imaging. Gallium-68 DOTATATE uses gallium-68 attached to a targeting ligand for PET imaging. Their indications, manufacturing processes, clinical value, and patent landscapes differ.

References

U.S. Food and Drug Administration. (n.d.-a). Gallium citrate Ga 67 injection prescribing information. FDA.
U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
U.S. Food and Drug Administration. (n.d.-c). Drugs@FDA: FDA-approved drugs database. FDA.
International Atomic Energy Agency. (2022). Nuclear medicine resources and radiopharmaceutical production guidance. IAEA.
Society of Nuclear Medicine and Molecular Imaging. (n.d.). Gallium-67 imaging and nuclear medicine practice resources. SNMMI.

GALLIUM CITRATE GA 67 Drug Patent Profile

When do Gallium Citrate Ga 67 patents expire, and what generic alternatives are available?

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