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Last Updated: March 26, 2026

Gallium citrate ga-67 - Generic Drug Details


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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.

There is one drug master file entry for gallium citrate ga-67. One supplier is listed for this compound.

Summary for gallium citrate ga-67
US Patents:0
Tradenames:2
Applicants:3
NDAs:4
Drug Master File Entries: 1
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

SponsorPhase
University Hospital, BordeauxPhase 2
U.S. Army Medical Research and Development CommandPhase 2
Rahul AggarwalPhase 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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare NEOSCAN gallium citrate ga-67 INJECTABLE;INJECTION 017655-001 Approved Prior to Jan 1, 1982 DISCN 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

Market Dynamics and Financial Trajectory of Gallium Citrate Ga-67

Last updated: February 15, 2026

Gallium citrate Ga-67 is a radiopharmaceutical used predominantly in diagnostic imaging, particularly for detecting lymphomas, melanoma, and other cancers. Its market is influenced by technological advancements, regulatory standards, and the competitive landscape of nuclear medicine.


What are the key drivers of the Ga-67 market?

  • It remains a standard imaging agent for lymphatic and tumor tissues, especially in regions lacking PET imaging infrastructure.
  • An aging global population with increased cancer incidence heightens demand for diagnostic imaging agents.
  • The periodic supply constraints due to its radioisotope half-life (78 hours) and production complexity.
  • Emergence of PET tracers (e.g., FDG) provides competition but does not fully replace Ga-67 in specific diagnostic contexts.

How does supply and production influence market stability?

Ga-67 is produced via cyclotron either domestically or through international collaborations, primarily in the US, Europe, and Japan. Because of its decaying nature, it requires onsite or nearby production, creating logistical constraints.

  • Limited production facilities contribute to shortages, impacting pricing and market availability.
  • The half-life constrains distribution, leading to regional dependence and pricing variability.
  • US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval standards influence supply chain reliability.

What is the current market size and growth trend?

While precise figures are scarce, estimates suggest:

Parameter 2022 estimate Notes
Global market size Approx. $50–70 million Based on hospital procurement, research use, and licensing
CAGR (Compound Annual Growth Rate) 2–3% (projected 2023–2028) Driven by healthcare expenditure growth and aging populations
Key regions North America, Europe, Asia-Pacific North America accounts for over 50% of usage, with Asia-Pacific showing increasing uptake

The market remains relatively niche, with growth limited by the aging infrastructure and dominance of alternative modalities like PET imaging.

Who are the primary stakeholders?

  • Pharmaceutical companies manufacturing Ga-67 (e.g., Curium, Eckert & Ziegler, Covidien).
  • Nuclear medicine centers and hospitals utilizing diagnostic radiopharmaceuticals.
  • Regulatory agencies setting standards for production and use.
  • Research institutions exploring new applications in cancer and infectious disease imaging.

What are the competitive and regulatory challenges?

  • The necessity to comply with strict radiopharmaceutical regulations affects manufacturing and commercialization.
  • Supply variability influences pricing, with shortages leading to price spikes.
  • Competition from newer imaging agents, including PET tracers, affects market share and demand trajectories.
  • Ongoing research might expand the clinical utility or replace Ga-67 with more effective agents, impacting long-term prospects.

What is the financial outlook for stakeholders?

  • Revenue forecasts depend on regional adoption rates and regulatory clarity.
  • Price per dose varies from $200–$500, correlated with regional regulatory costs and supply constraints.
  • Profit margins are limited due to high production costs and market size.
  • Investment in infrastructure for regular supply could stabilize pricing but requires significant capital expenditure.

Summary of risks and opportunities

Risks Opportunities
Supply disruptions Expansion into new markets (e.g., Asia-Pacific)
Competition from PET tracers Developing new indications for Ga-67
Regulatory hurdles Enhancing production efficiency to reduce costs
Replacing with more advanced imaging agents Collaborating on innovative diagnostic applications

Key Takeaways

  • Ga-67 remains relevant in specific diagnostic contexts but faces constrained growth due to supply challenges and competition.
  • Global market size is estimated between $50 million to $70 million, growing modestly at 2–3% annually.
  • Market stability depends heavily on production infrastructure and supply chain logistics.
  • Regulatory standards play a crucial role in market entry, supply consistency, and pricing.
  • Future growth hinges on expanding applications and improving production efficiency amid competition from PET-based diagnostics.

FAQs

1. How does Ga-67 compare to PET imaging agents in clinical use?
Ga-67 is primarily used for lymphoma and certain infections, with slower imaging protocols and lower resolution than PET agents like FDG. PET agents generally have higher sensitivity but less long-term stability and higher costs. Ga-67 remains useful in specific scenarios where PET is unavailable.

2. What factors can impact the price of Ga-67 radiopharmaceuticals?
Price fluctuations are driven by production costs, supply chain disruptions, regional regulatory fees, and demand fluctuations based on clinical needs.

3. Are there upcoming regulatory changes affecting Ga-67?
Regulatory standards are evolving, emphasizing production quality, safety, and traceability. Changes may impose stricter manufacturing controls, potentially increasing compliance costs.

4. What are the main clinical indications for Ga-67?
Detection of Hodgkin’s and non-Hodgkin’s lymphoma, melanoma metastases, and certain infectious processes.

5. Is there ongoing research to replace Ga-67?
Research focuses on alternative SPECT and PET tracers with better resolution and shorter half-lives, but Ga-67 maintains niche utility, especially where PET infrastructure is lacking.


Sources:
[1] Market research estimates; industry reports.
[2] U.S. Food and Drug Administration (FDA) documentation.
[3] European Medicines Agency (EMA) guidelines.

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