GALLIUM GA 68 GOZETOTIDE Drug Patent Profile

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Which patents cover Gallium Ga 68 Gozetotide, and what generic alternatives are available?

Gallium Ga 68 Gozetotide is a drug marketed by Ionetix, Radiomedix, Univ Ca Los Angeles, and Univ Of Ca San Fran. and is included in four NDAs.

The generic ingredient in GALLIUM GA 68 GOZETOTIDE is gallium ga-68 gozetotide. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.

Summary for GALLIUM GA 68 GOZETOTIDE

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Clinical Trials:	9
Patent Applications:	122
DailyMed Link:	GALLIUM GA 68 GOZETOTIDE at DailyMed

Recent Clinical Trials for GALLIUM GA 68 GOZETOTIDE

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

Sponsor	Phase
BLUE EARTH DIAGNOSTICS (UNITED KINGDOM)	PHASE2
Fred Hutchinson Cancer Center	PHASE2
Institute for Prostate Cancer Research (IPCR)	PHASE2

See all GALLIUM GA 68 GOZETOTIDE clinical trials

Pharmacology for GALLIUM GA 68 GOZETOTIDE

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for GALLIUM GA 68 GOZETOTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ionetix	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	219189-001	May 14, 2026	AP	RX	No	No
Univ Of Ca San Fran	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212643-001	Dec 1, 2020	AP	RX	Yes	Yes
Radiomedix	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	216410-001	Jun 8, 2026	AP	RX	No	No
Univ Ca Los Angeles	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212642-001	Dec 1, 2020		RX	Yes	Yes

Gallium Ga 68 Gozetotide Market Dynamics, Financial Trajectory, and Patent Outlook

Last updated: August 14, 2026

Gallium Ga 68 gozetotide is a PSMA-targeted PET diagnostic used to identify prostate cancer lesions. The principal U.S. products are Telix Pharmaceuticals’ Illuccix and Novartis’ Locametz. The market is expanding with PSMA-PET adoption, prostate-cancer staging, biochemical-recurrence imaging, and patient selection for lutetium-177 PSMA therapy. Telix has the stronger disclosed commercial trajectory, while Novartis benefits from vertical integration with Pluvicto.

What is gallium Ga 68 gozetotide?

Gallium Ga 68 gozetotide is a radiolabeled small-molecule PSMA ligand, also known as Ga-68 PSMA-11. It binds to prostate-specific membrane antigen expressed on many prostate cancer cells and enables PET imaging.

In the United States, it is supplied through two principal products:

Product	Sponsor	FDA approval	Commercial format	Primary strategic role
Illuccix	Telix Pharmaceuticals	December 2021	Kit for preparation of Ga-68 gozetotide injection	Stand-alone PSMA-PET diagnostic
Locametz	Novartis	May 2022	Kit for preparation of Ga-68 gozetotide injection	Diagnostic companion to Novartis’ radioligand portfolio

Both products require a Ga-68 source, generally a generator, radiopharmacy infrastructure, trained personnel, and time-sensitive preparation. The 67.7-minute physical half-life of Ga-68 limits distribution distance and increases the importance of local manufacturing and hospital access.

What are the FDA-approved uses of Illuccix and Locametz?

Illuccix and Locametz are approved for PSMA-PET imaging in adults with suspected prostate cancer metastasis who are candidates for initial definitive therapy and in adults with suspected recurrence based on elevated prostate-specific antigen levels.

The products are also used to identify PSMA-positive metastatic castration-resistant prostate cancer patients who may be eligible for lutetium Lu-177 vipivotide tetraxetan therapy. This creates a direct commercial link between diagnostic imaging and therapeutic radioligand treatment.

The FDA label supports several commercial demand drivers:

• Initial staging before surgery or radiation.
• Detection of recurrent disease after treatment.
• Localization of metastatic disease.
• Selection of patients for PSMA-directed radioligand therapy.
• Treatment planning and disease monitoring.

The regulatory value of the products increases as PSMA-directed therapies move earlier in the prostate-cancer treatment pathway.

How large is the gallium Ga 68 gozetotide market?

The market is a subset of the broader PSMA-PET and radiopharmaceutical imaging market. Published company disclosures do not provide a fully separated global market figure for Ga-68 gozetotide. The most reliable commercial indicators are product sales, PET center penetration, radiopharmacy capacity, reimbursement and the growth of PSMA-directed therapy.

The market has several structural characteristics:

Market factor	Effect on demand
Rising prostate cancer incidence	Expands the eligible imaging population
Increasing use of PSMA-PET	Displaces some conventional imaging and older PET tracers
Growth of Pluvicto	Increases demand for PSMA-positive patient identification
More PET centers and radiopharmacies	Expands geographic access
Ga-68 generator availability	Constrains supply in locations without reliable radiopharmacy infrastructure
Reimbursement adoption	Determines utilization outside major academic centers
F-18 PSMA competition	Creates pressure on scan scheduling, geographic reach and tracer choice

Telix has reported strong growth in its radiopharmaceutical business, led by Illuccix in the United States. Telix reported total FY2024 revenue of approximately A$630 million, representing growth of more than 50% from the prior year. The company does not present all Illuccix revenue as a separately audited line item, but Illuccix remains a core commercial product in its portfolio (Telix Pharmaceuticals Limited, 2025).

Novartis does not separately disclose Locametz revenue in the same detail. Locametz is strategically important because it supports the company’s prostate-cancer radioligand franchise, including Pluvicto. Novartis reports Pluvicto and Lutathera financial performance more prominently than diagnostic-tracer revenue (Novartis AG, 2025).

What is the financial trajectory for Illuccix and Locametz?

Telix and Illuccix

Telix’s financial trajectory has been driven by the transition from development-stage radiopharmaceutical company to commercial oncology supplier. Illuccix has contributed recurring revenue from high-volume U.S. prostate-cancer imaging.

Key commercial factors include:

1. Expanded U.S. ordering by hospitals and independent imaging centers.
2. Growth of centralized and regional radiopharmacy production.
3. Broader reimbursement for PSMA-PET.
4. Increased referrals from urologists, radiation oncologists and medical oncologists.
5. Use of Illuccix in the pathway for Pluvicto eligibility.

Telix’s commercial model is sensitive to production uptime, generator access, delivery logistics and site-level utilization. Unlike conventional drugs, a Ga-68 product cannot be stocked for long periods. Sales growth therefore requires operational expansion rather than only additional prescriptions.

Novartis and Locametz

Novartis has a different economic position. Locametz is part of an integrated radioligand ecosystem that includes:

• Pluvicto for PSMA-positive metastatic castration-resistant prostate cancer.
• Lutathera for somatostatin receptor-positive neuroendocrine tumors.
• Novartis radioligand manufacturing and distribution capabilities.
• Companion diagnostic and patient-selection infrastructure.

Locametz can generate direct diagnostic revenue, but its larger strategic value is indirect. A reliable PSMA-PET pathway can support Pluvicto patient identification, treatment-center expansion and therapeutic conversion.

Novartis’ principal financial exposure is therefore tied to the growth of the broader radioligand franchise rather than Locametz sales alone. Pluvicto has become a major growth product for Novartis, with reported sales exceeding $1 billion annually by 2024 (Novartis AG, 2025).

How does Illuccix compare with Locametz?

Attribute	Illuccix	Locametz
Manufacturer	Telix	Novartis
U.S. approval	December 2021	May 2022
Active diagnostic agent	Ga-68 gozetotide	Ga-68 gozetotide
Product type	Radiolabeling kit	Radiolabeling kit
Core indication	PSMA-PET imaging	PSMA-PET imaging
Commercial advantage	First-mover position and radiopharmacy expansion	Integration with Pluvicto and Novartis radioligand infrastructure
Main risk	Supply scale, reimbursement and competition	Lower diagnostic visibility within a larger portfolio
Direct financial disclosure	Telix reports company-level growth, with limited product-level detail	Locametz sales are not separately disclosed in major public reporting
Competitive positioning	Broad independent diagnostic adoption	Strong therapy-linked adoption

The products are clinically substitutable in many settings because they use the same active radiolabeled ligand. Competition is therefore determined less by molecular differentiation and more by supply reliability, site contracting, reimbursement, ordering systems, radiopharmacy reach and relationships with therapeutic centers.

Which companies challenge gallium Ga 68 gozetotide?

The main competitive threat comes from alternative PSMA-PET tracers, particularly fluorine-18 products.

Product	Active tracer	Sponsor	Competitive distinction
Illuccix	Ga-68 gozetotide	Telix	Established Ga-68 PSMA-PET product
Locametz	Ga-68 gozetotide	Novartis	Integrated with Novartis radioligand therapy
Pylarify	F-18 piflufolastat	Lantheus	Longer half-life and broader distribution potential
Posluma	F-18 flotufolastat	Blue Earth Diagnostics, a Bracco company	F-18 PSMA-PET alternative
Other regional tracers	Various PSMA ligands	Multiple companies and academic suppliers	Local or country-specific substitution

F-18 tracers have a physical half-life of approximately 110 minutes, longer than Ga-68. That can improve transport radius and scheduling flexibility. Ga-68 products retain advantages where generators and radiopharmacies are already established, particularly in centers with existing PSMA-PET workflows.

The competition is not limited to tracer performance. The decisive variables include scan availability, reimbursement, interpretation expertise, hospital contracting and the ability to coordinate imaging with radioligand therapy.

When do Illuccix and Locametz lose exclusivity?

Neither product should be analyzed as a conventional small-molecule tablet with a single composition-of-matter patent. Ga-68 gozetotide is a diagnostic radiopharmaceutical supplied as a kit, and its commercial protection is distributed across regulatory exclusivity, manufacturing know-how, kit formulation, radiolabeling procedures, quality systems and supply infrastructure.

Regulatory exclusivity

The FDA approved Illuccix in December 2021 and Locametz in May 2022. Public FDA approval materials do not establish a long, standalone new chemical entity exclusivity period comparable to a newly approved therapeutic small molecule. The principal commercial barriers are therefore product approval, manufacturing compliance, radiopharmacy operations and market access rather than a clearly defined NCE exclusivity cliff (U.S. Food and Drug Administration, 2021, 2022).

Patent exclusivity

The active ligand and PSMA-targeting concept have substantial prior-art exposure. Patent strength is more likely to reside in:

• Specific chelator-ligand configurations.
• Radiolabeling methods.
• Kit compositions.
• Stabilizers and formulation conditions.
• Generator-to-dose preparation methods.
• Manufacturing and quality-control processes.
• Therapeutic or diagnostic use claims.

Public Orange Book analysis should distinguish between the NDA product and patents covering broader radiochemistry or manufacturing processes. A definitive patent-expiration date for the commercial product cannot be inferred from the FDA approval date alone. FDA Orange Book records should be reviewed alongside USPTO assignments, patent-family status and any applicable terminal disclaimers before relying on a specific loss-of-exclusivity date (U.S. Food and Drug Administration, 2025).

What is the Orange Book status of gallium Ga 68 gozetotide?

The Orange Book is less informative for Ga-68 gozetotide than for conventional oral drugs. The key issues are:

• Whether patents are listed against the specific NDA.
• Whether the listed claims cover the finished kit, the active ligand or only a manufacturing process.
• Whether an ANDA pathway is commercially practical.
• Whether an applicant would need separate PET-radiopharmacy infrastructure.
• Whether the product is supplied as a kit requiring in-house radiolabeling.

Illuccix and Locametz are not interchangeable from a regulatory standpoint merely because both contain Ga-68 gozetotide. An abbreviated applicant would need to address kit composition, radiochemical purity, radionuclidic purity, labeling performance, stability and manufacturing controls.

A Paragraph IV challenge is technically possible for a listed patent, but the market is less likely to experience a simple tablet-style generic launch. The likely entrant would need an approved radiopharmaceutical kit and a supply network capable of producing doses near the imaging site.

What generic entry risks exist for Illuccix and Locametz?

Generic risk is moderate over the long term but lower than the risk suggested by the apparent simplicity of the active ingredient.

Factors increasing generic risk

• The Ga-68 gozetotide ligand is a defined chemical entity.
• Hospitals may accept therapeutically equivalent imaging products.
• F-18 PSMA products demonstrate that alternative PSMA-PET agents can obtain regulatory approval.
• Radiopharmacy operators can support multiple products.
• Patent claims focused only on narrow formulations may be vulnerable to design-around strategies.

Factors reducing generic risk

• Short radionuclide half-life requires regional production.
• Generator access and radiopharmacy licensing create operational barriers.
• PET centers require validated quality systems.
• Commercial success depends on reimbursement and scheduling, not only approval.
• Supplier reliability is important for time-sensitive oncology imaging.
• A substitute product must demonstrate diagnostic performance and operational equivalence.

The most credible erosion scenario is not a single low-cost generic replacing both brands. It is gradual share loss to F-18 PSMA tracers, hospital-compounded products where permitted, and new Ga-68 kits supplied by regional radiopharmacy networks.

What patent litigation affects gallium Ga 68 gozetotide?

No major publicly disclosed U.S. patent litigation directly involving Illuccix or Locametz had become a central commercial event in the available company and FDA disclosures through 2024. The absence of a prominent case does not remove future litigation risk.

Potential disputes could involve:

• Ownership of PSMA ligand patents.
• Patent assignment and licensing rights.
• Radiolabeling procedures.
• Generator-based production methods.
• Formulation and kit stability.
• Use of Ga-68 PSMA imaging for selecting patients for radioligand therapy.
• Trade secrets covering manufacturing, release testing and distribution.

Litigation risk is higher where a company relies on third-party technology or where a patent owner can assert a process claim against multiple radiopharmacy sites. Licensing and patent-chain diligence is therefore more important than the number of patents alone.

What licensing deals and manufacturing barriers shape the market?

The commercial market depends on a network of licensed or contracted capabilities:

• Ga-68 generator suppliers.
• Radiopharmaceutical manufacturing sites.
• Hospital nuclear pharmacies.
• Third-party radiopharmacies.
• PET imaging centers.
• Cold-chain and radiation-compliant logistics providers.
• Therapeutic radioligand treatment centers.

Telix’s strategy has emphasized direct commercial supply and manufacturing expansion. Novartis has greater internal alignment between diagnostic imaging and therapeutic radioligand manufacturing. Both models face the same basic constraint: Ga-68 doses must be prepared, released and administered within a narrow time window.

Manufacturing intellectual property can be more durable commercially than a narrow ligand patent. A competitor may obtain regulatory approval but still struggle to achieve reliable dose availability across a national market.

What is the geographic coverage of gallium Ga 68 gozetotide?

The United States is the most commercially developed market for Illuccix and Locametz. Adoption is also supported by PSMA-PET use in Europe, Australia and other markets, although product names, reimbursement and approved indications vary by jurisdiction.

Geographic expansion depends on:

• Local regulatory approval.
• Availability of Ga-68 generators or cyclotron-linked production.
• Reimbursement for PSMA-PET.
• Nuclear medicine staffing.
• Proximity of radiopharmacy production to imaging centers.
• National acceptance of PSMA-PET guidelines.

The addressable market is therefore regional rather than purely global. A company with a dense production network can compete effectively against a product with equivalent clinical performance but weaker delivery coverage.

What generic launch scenarios are most likely?

Scenario 1: Continued branded expansion

Telix and Novartis continue to expand PSMA-PET access. Illuccix remains a major independent diagnostic product, while Locametz grows in centers linked to Pluvicto. This is the most favorable scenario for current suppliers.

Scenario 2: F-18 substitution

F-18 piflufolastat and F-18 flotufolastat gain share because of longer half-life, easier distribution and improved scheduling. Ga-68 products remain strong in generator-supported centers.

Scenario 3: Regional Ga-68 competition

New suppliers launch Ga-68 PSMA kits or radiopharmacy-produced doses. Price competition develops first in high-volume metropolitan markets, while incumbent suppliers retain rural and integrated-network advantages.

Scenario 4: Therapy-led diagnostic demand

Earlier-line Pluvicto use expands the number of patients requiring PSMA-PET. Diagnostic demand grows, but the economic value shifts toward integrated therapy providers and treatment-center networks.

How strong is the patent estate for gallium Ga 68 gozetotide?

The patent estate is best characterized as commercially meaningful but fragmented.

Protection category	Likely strength	Commercial relevance
Broad PSMA-targeting concept	Limited to moderate because of prior art	May not block all alternatives
Specific ligand chemistry	Moderate, depending on claim scope and expiry	Can support product differentiation
Kit formulation	Moderate	May delay direct copies
Radiolabeling process	Moderate to strong if difficult to design around	Important for regulatory comparability
Manufacturing know-how	Strong operational value, difficult to replicate quickly	Supports supply reliability
Method-of-use claims	Variable	May protect selected imaging or therapy-selection uses
Trademark and brand	Moderate	Supports contracting and physician familiarity
Distribution infrastructure	Strong commercial barrier	Can outlast narrow patent protection

The principal defensive asset is the combination of regulatory approval, validated radiochemistry, manufacturing scale and customer access. A competitor that copies the ligand but cannot match dose availability may have limited commercial impact.

Key Takeaways

• Gallium Ga 68 gozetotide is marketed in the U.S. primarily as Illuccix by Telix and Locametz by Novartis.
• Telix has the clearer disclosed financial growth trajectory, with company revenue reaching about A$630 million in FY2024.
• Novartis’ Locametz strategy is linked to Pluvicto and the broader radioligand-therapy franchise.
• The largest competitive threat comes from F-18 PSMA tracers, especially Pylarify and Posluma.
• A conventional generic cliff is unlikely because Ga-68 supply requires generators, radiopharmacy operations and time-sensitive logistics.
• Patent protection is likely more important for formulations, radiolabeling and manufacturing methods than for the broad PSMA concept.
• FDA approval dates do not establish a definitive patent-expiration date.
• No major publicly disclosed U.S. patent litigation had materially disrupted the market through the available 2024 disclosures.
• Future revenue growth depends on PSMA-PET adoption, reimbursement, Pluvicto expansion and radiopharmacy capacity.
• The strongest commercial moat is operational execution combined with regulatory approval, not the active ligand alone.

FAQs

Is gallium Ga 68 gozetotide the same as PSMA-11?

Yes. Gallium Ga 68 gozetotide is the radiolabeled form of the PSMA-11 ligand, used for PET imaging of PSMA-expressing prostate cancer lesions.

Which company sells the leading Ga-68 PSMA product in the United States?

Telix sells Illuccix, while Novartis sells Locametz. Telix has a stronger independent diagnostic commercialization profile; Novartis has greater integration with PSMA-directed therapy.

Does Ga-68 gozetotide compete with PSMA therapy?

No. It is a diagnostic imaging agent. It helps identify PSMA-positive disease and can support selection for PSMA-directed radioligand therapy such as Pluvicto.

Can a hospital use Illuccix and Locametz interchangeably?

They have the same core diagnostic agent and overlapping indications, but each is a separately approved product with its own kit, labeling, supply chain and quality-control requirements.

What is the biggest long-term threat to Ga-68 gozetotide revenue?

The largest threat is substitution by F-18 PSMA tracers, which can offer longer distribution windows and greater scheduling flexibility. Reduced reimbursement or slower PSMA-PET adoption would create a second major risk.

References

1. Novartis AG. (2025). Annual report 2024. Basel, Switzerland: Author.

2. Telix Pharmaceuticals Limited. (2025). Annual report 2024. Melbourne, Australia: Author.

3. U.S. Food and Drug Administration. (2021). Illuccix: Prescribing information and approval materials. Silver Spring, MD: Author.

4. U.S. Food and Drug Administration. (2022). Locametz: Prescribing information and approval materials. Silver Spring, MD: Author.

5. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. Silver Spring, MD: Author.

6. U.S. Food and Drug Administration. (2021). Pylarify: Prescribing information. Silver Spring, MD: Author.

7. U.S. Food and Drug Administration. (2023). Posluma: Prescribing information. Silver Spring, MD: Author.