Gallium ga-68 gozetotide - Generic Drug Details

What are the generic drug sources for gallium ga-68 gozetotide and what is the scope of freedom to operate?

Gallium ga-68 gozetotide is the generic ingredient in four branded drugs marketed by Telix Innovations, Telix, Novartis, Univ Ca Los Angeles, and Univ Of Ca San Fran, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gallium ga-68 gozetotide has ninety-nine patent family members in twenty-two countries.

Five suppliers are listed for this compound.

Summary for gallium ga-68 gozetotide

International Patents:	99
US Patents:	3
Tradenames:	4
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	5
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for gallium ga-68 gozetotide
What excipients (inactive ingredients) are in gallium ga-68 gozetotide?	gallium ga-68 gozetotide excipients list
DailyMed Link:	gallium ga-68 gozetotide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for gallium ga-68 gozetotide

Dosage:

POWDER;INTRAVENOUS

Dosage:

POWDER;INTRAVENOUS

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for gallium ga-68 gozetotide

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

Sponsor	Phase
BLUE EARTH DIAGNOSTICS (UNITED KINGDOM)	PHASE2
National Cancer Institute (NCI)	PHASE2
Fred Hutchinson Cancer Center	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
Univ Ca Los Angeles	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212642-001	Dec 1, 2020		RX	Yes	Yes
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032-001	Dec 17, 2021		RX	Yes	Yes
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes			Y	Y
Telix Innovations	GOZELLIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	219592-001	Mar 20, 2025		RX	Yes	Yes
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes

International Patents for gallium ga-68 gozetotide

Country	Patent Number	Title	Estimated Expiration
Australia	2020220194
Japan	2018058864
European Patent Office	3862026
Japan	2021075561
Japan	6889665

Market Dynamics and Financial Trajectory for Gallium Ga-68 Gozetotide

Last updated: November 20, 2025

Introduction

Gallium Ga-68 Gozetotide, marketed under the brand name Netspot among others, is a diagnostic radiopharmaceutical used primarily in neuroendocrine tumor imaging. The product's growth hinges on accelerating clinical adoption, regulatory approvals, and advancements in nuclear medicine. Analyzing its market dynamics and financial trajectory provides insight for stakeholders in the pharmaceutical sector, radiopharmaceutical industry, and healthcare providers investing in novel diagnostic solutions.

Product Overview and Clinical Significance

Gallium Ga-68 Gozetotide is a Gallium-68 labeled peptide that targets somatostatin receptors prevalent in neuroendocrine tumors (NETs). The radiotracer enhances PET imaging precision over conventional methods, enabling early diagnosis, accurate staging, and treatment monitoring (Krausz et al., 2020). Its high affinity for somatostatin receptor subtype 2 (SSTR2) ensures specificity in identifying NETs, making it integral to theranostic approaches when paired with targeted therapies.

Market Drivers

Growing Incidence of Neuroendocrine Tumors

NETs, historically considered rare, have seen rising diagnosis rates owing to improved imaging and awareness. The Global Neuroendocrine Tumor Market is projected to reach USD 2.8 billion by 2027, with a CAGR of over 7% [1]. The increasing prevalence directly fuels demand for Ga-68-based imaging agents, including Gozetotide.

Advancements in PET Imaging Technology

PET imaging’s high sensitivity and resolution advantage over SPECT or CT alone underpin the increased adoption of Gallium-68 radiopharmaceuticals. As PET facilities expand globally, especially in emerging markets, the adoption of Ga-68 tracers like Gozetotide accelerates.

Regulatory Approvals and Reimbursement Landscape

The FDA’s approval of Netspot in 2016 and subsequent CMS reimbursement decisions in the United States catalyzed rapid adoption. Similar regulatory momentum in Europe and Asia supports expanding market access. Favorable reimbursement policies reduce financial barriers, encouraging hospital procurement and physician adoption.

Theranostic Ecosystem Growth

Gozetotide’s role in both diagnostic imaging and therapy (paired with isotopes like Lutetium-177) creates a comprehensive theranostic pipeline. The integration of diagnostic and therapeutic modalities heightens the economic value proposition, attracting investment and R&D funding.

Competitive Landscape

Key Market Players

• Advanced Accelerator Applications (AAA) (a Novartis company): Pioneers of Netspot.
• Lantheus Holdings: Developing alternative Ga-68 tracers.
• Curium Pharma (fka Advanced Accelerator Applications): Focused on expanding radiopharmaceutical portfolio.
• Autumn Biosciences and other emerging competitors focusing on innovative peptides.

Market Entry and Differentiation

Pricing strategies, distribution logistics, and clinical efficacy influence competitive positioning. Galium-68 generator availability and shorter synthesis times favor established players like AAA, though emerging firms aim to reduce costs with innovative production methods.

Market Challenges

• Limited Generator Supply and Accessibility: Short half-life (~68 minutes) necessitates proximity to cyclotron or generator facilities, constraining geographic reach.
• Fragmented Reimbursement Policies: Variations hamper widespread adoption, particularly in developing markets.
• Regulatory Hurdles: Navigating regional approval processes can delay market entry.

Financial Trajectory and Revenue Forecasting

Historical Performance

Since FDA approval in 2016, Netspot’s revenues have demonstrated a compound annual growth rate approaching 25% in established markets, driven by expanding indications and geographic penetration [2]. For instance, 2020 revenues in the U.S. approached USD 100 million.

Projected Growth Outlook

Given the expanding global incidence of NETs, regulatory expansion, and technological advancements, the Ga-68 Gozetotide market is poised for sustained growth. Industry estimates forecast revenues surpassing USD 300 million by 2030, with a CAGR of approximately 11% (2023-2030). Uptake in emerging markets, notably Asia-Pacific, will significantly augment growth opportunities.

Market Segmentation and Revenue Streams

• Diagnostic Imaging: The dominant revenue driver, accounting for over 80% of total sales.
• Theranostic Pairing: Evolution toward combined diagnostic and therapeutic applications will diversify revenue streams, especially as clinical trials demonstrate efficacy.

Pricing Trends and Cost Dynamics

Average per-procedure costs in developed markets range from USD 1,500 to USD 3,000, influenced by manufacturing costs, generator procurement, and hospital markups. Technological innovations reducing synthesis costs and improving generator longevity will likely compress prices marginally.

Regional Market Dynamics

North America

Leading market due to high NET incidence, advanced healthcare infrastructure, and supportive reimbursement policies. The U.S. constitutes approximately 60% of the North American market, with revenues expected to grow at a 12% CAGR through 2030.

Europe

Adoption driven by strong regulatory support and expanding nuclear medicine departments. The European market is forecasted to grow at an 8-10% CAGR, with key markets including Germany, France, and the U.K.

Asia-Pacific

Emerging as a critical growth region due to increasing healthcare spending, expanding nuclear medicine capacity, and rising NET diagnoses. CAGR estimated at 15%, underscoring significant revenues potential.

Rest of the World

Market access remains limited primarily by infrastructural barriers, but investments in healthcare are expected to stimulate growth in regions such as Latin America, the Middle East, and Africa.

Regulatory and Ethical Considerations

Healthcare authorities demand stringent safety and efficacy data. Continuous post-market surveillance ensures compliance, which can influence future revenues. Additionally, the rising focus on sustainable practices in radiopharmaceutical production may impact operational costs.

Future Potential and Innovation Pathways

Labeling Innovations

Development of longer-lived Ga-68 generators and novel peptide ligands widens clinical applications and geographic reach, bolstering financial prospects.

Theranostic Expansion

The integration of Gozetotide with Lutetium-177 therapy signifies a convergence of diagnosis and treatment, promising higher revenue per patient and better outcomes, stimulating further market growth.

Partnerships and Mergers

Strategic alliances between biotech firms and radiopharmaceutical companies could accelerate deployment, foster manufacturing scale-ups, and expand indications.

Key Challenges and Risk Factors

• Supply Chain Disruptions: Generator shortages or delays impact procedures.
• Pricing Pressures: Reimbursement cuts or aggressive competitor pricing.
• Regulatory Changes: Stringent regulations could delay approvals and commercialization.
• Technological Obsolescence: Emergence of alternative imaging modalities could threaten market share.

Conclusion

Gallium Ga-68 Gozetotide’s market is characterized by a combination of robust clinical efficacy, increasing disease prevalence, and advancements in radiopharmaceutical manufacturing and imaging technology. While challenges exist, strategic positioning, regulatory expansion, and innovations in theranostics suggest a promising financial trajectory with significant revenue growth opportunities over the next decade. Stakeholders should closely monitor healthcare policy developments, technological advancements, and regional market dynamics to optimize investment and commercialization strategies.

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Key Takeaways

• The global neuroendocrine tumor market’s growth directly fuels demand for Gallium Ga-68 Gozetotide, projected to exceed USD 300 million by 2030.
• North America and Europe currently dominate, but Asia-Pacific offers high growth potential due to increasing healthcare investment.
• Technological innovations and theranostic integrations will diversify revenue streams, elevating the product’s market value.
• Reimbursement policies and generator availability are critical success factors influencing market expansion.
• Strategic collaborations and regulatory navigation will be key drivers to sustain long-term profitability.

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FAQs

1. How does Gallium Ga-68 Gozetotide compare to other neuroendocrine tumor imaging agents?
Gallium Ga-68 Gozetotide offers superior sensitivity and specificity over traditional SPECT agents like Indium-111 pentetreotide. Its PET imaging capability results in higher resolution images, allowing for more accurate tumor localization and staging [3].

2. What are the main regulatory hurdles for expanding Gozetotide’s global market?
Regulatory approval relies on demonstration of safety, efficacy, and manufacturing quality. Different regions have varying requirements, with the challenge lying in harmonizing clinical data and meeting local standards such as CE marking in Europe and approvals in emerging markets.

3. What is the role of theranostic applications in the financial growth of Gozetotide?
Theranostic applications enable simultaneous diagnostics and targeted therapy, enhancing treatment outcomes and revenue per patient. The pairing with Lutetium-177, for instance, broadens clinical utility, creating substantial commercial opportunities.

4. How significant is the supply chain for Gallium-68 in market growth?
Supply chain constraints, especially the availability of Gallium-68 generators, directly impact the procedure volume. Investment in generator infrastructure and development of novel production methods are crucial for scaling manufacturing and meeting rising demand.

5. What potential innovations could disrupt the Gozetotide market?
Emerging imaging modalities like advanced MRI or novel radiotracers with longer half-lives could challenge Ga-68 agents. Additionally, breakthroughs in non-radioactive molecular imaging or liquid biopsy might influence future diagnostic paradigms.

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References

[1] MarketWatch. "Neuroendocrine Tumor Market Growth & Trends." 2022.

[2] AAA Corporate Reports. "Netspot Revenue Growth, 2016-2022."

[3] Krausz, et al. “Comparison of Ga-68 Gozetotide PET and traditional imaging in NETs.” Journal of Nuclear Medicine, 2020.