GALLIUM GA-68 GOZETOTIDE - Generic Drug Details

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

Gallium ga-68 gozetotide is the generic ingredient in three branded drugs marketed by Telix, Novartis, Univ Ca Los Angeles, and Univ Of Ca San Fran, and is included in four 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-one patent family members in twenty-one countries.

Four suppliers are listed for this compound.

Summary for GALLIUM GA-68 GOZETOTIDE

International Patents:	91
US Patents:	3
Tradenames:	3
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	4
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

^*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
Novartis Pharmaceuticals	Phase 3
Mayo Clinic	Phase 3
Eli Lilly and Company	Phase 1/Phase 2

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
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes
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
Univ Of Ca San Fran	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212643-001	Dec 1, 2020		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
Canada	2958471	KIT POUR LE RADIOMARQUAGE AU 68GA COMPRENANT UN INHIBITEUR METALLIQUE (KIT FOR RADIOLABELLING WITH 68GA COMPRISING A METAL INHIBITOR)
Canada	2979127	PROCEDES ET TROUSSES DE PREPARATION DE COMPLEXES DE RADIONUCLEIDES (METHODS AND KITS FOR PREPARING RADIONUCLIDE COMPLEXES)
Japan	6625690
European Patent Office	3831380	CONJUGUÉS COMPRENANT UN LIGAND DU PSMA ET UN LIEUR ET PROCÉDÉS POUR LEUR UTILISATION (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING)
Australia	2016230890	Methods and kits for preparing radionuclide complexes

GALLIUM GA-68 GOZETOTIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gallium Ga-68 Gozetotide

Introduction to Gallium Ga-68 Gozetotide

Gallium Ga-68 gozetotide, also known as Ga-68 PSMA-11, is a radiopharmaceutical agent used in the diagnosis of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. This drug is a crucial tool in positron emission tomography (PET) imaging, particularly for primary staging, suspected recurrence, and identifying patients with progressive metastatic castration-resistant prostate cancer (mCRPC)[2][5].

Market Size and Growth

The gallium-68 market, which includes Ga-68 gozetotide, is projected to experience significant growth over the coming years. By 2030, the global gallium-68 market is estimated to reach USD 1,070.34 million, growing at a Compound Annual Growth Rate (CAGR) of 4.0% from 2022 to 2030. In 2022, the market was valued at USD 782.36 million[1].

Key Drivers of Market Growth

Several factors are driving the growth of the gallium-68 market, including:

Increasing Prevalence of Prostate Cancer and Neuroendocrine Tumors

The rise in the incidence and prevalence of prostate cancer and neuroendocrine tumors is a major driver. According to the International Agency for Research on Cancer (IARC), the number of cancer cases in the US is expected to increase from 2.28 million in 2020 to 3.12 million by 2040, which will boost demand for nuclear imaging techniques[1].

Advancements in Nuclear Medicine

Advancements in technologies such as hybrid imaging and the development of novel radiopharmaceuticals for diagnosis and treatment are contributing to the growth. The introduction of molecular imaging techniques based on the tracer principle is also significant[1][4].

Growing Use of Nuclear Imaging Techniques

The increasing use of nuclear imaging techniques in various medical disciplines, including oncology, cardiology, and endocrinology, is another key driver. Gallium-68's good positron-emitting properties and its easy availability from 68Ge/68Ga generators make it a preferred choice for PET imaging[1][4].

Market Segmentation

The gallium-68 market is segmented by application and end user.

By Application

The oncology segment holds the largest market share and is anticipated to register the highest CAGR during the forecast period. This segment is further subsegmented into prostate cancer, neuroendocrine tumors, and others. Ga-68 gozetotide is particularly significant in the diagnosis of prostate cancer, making the oncology segment a dominant force in the market[1].

By End User

The market is categorized into hospitals, diagnostic and imaging centers, and others. Hospitals held the largest market share in 2022 and are expected to continue growing at the highest CAGR during the forecast period[1].

Regional Analysis

North America

North America held the largest market share in 2022, driven by advancements in healthcare infrastructure, the rising incidence of prostate cancer, and product innovations by key players. The region is expected to continue dominating the market due to rapid technological advancements in PET systems[1].

Asia Pacific

The Asia Pacific region is also witnessing significant growth due to economic expansion, improved healthcare facilities, and increasing consumer awareness. Countries like China and India offer substantial opportunities for the gallium-68 market, with major businesses planning to invest and expand in these regions[4].

Challenges and Limitations

Despite the growth prospects, there are challenges to consider:

Short Shelf-Life

The short half-life of gallium-68 (68 minutes) is a significant limitation. This requires efficient logistics and timely use to maximize its diagnostic utility[1].

Regulatory and Safety Considerations

The use of radioactive tracers comes with regulatory and safety concerns. For instance, the interaction of gallium Ga-68 gozetotide with other therapies targeting the androgen pathway can affect its performance, and there are limited data on its long-term toxicity[5].

Key Players and Competitive Landscape

The gallium-68 market includes several key players such as Novartis AG, Telix Pharmaceuticals (US) Inc, IRE-ELiT SA, ITM Medical Isotopes GmbH, and Eckert & Ziegler Radiopharma GmbH. These companies are investing in research and development to expand the applications of gallium-68 and improve its delivery systems[1][4].

Financial Trajectory

The financial trajectory of the gallium-68 market is positive, with a projected growth from USD 782.36 million in 2022 to USD 1,070.34 million by 2030. This growth is driven by increasing demand for nuclear imaging, advancements in technology, and the expanding prevalence of diseases that require diagnostic imaging using gallium-68[1].

Illustrative Statistics

• Market Value in 2022: USD 782.36 million
• Projected Market Value by 2030: USD 1,070.34 million
• CAGR from 2022 to 2030: 4.0%
• Prevalence of Prostate Cancer in the US: Expected to increase from 2.28 million cases in 2020 to 3.12 million by 2040[1].

Expert Insights

"Gallium-68 has a growing influence in molecular imaging by positron emission tomography, owing to its easy availability from 68Ge/68Ga generators and cyclotrons, good radiation properties, and rich Ga3+ coordination chemistry," notes an analyst from the market research report. This underscores the potential for continued growth and innovation in the gallium-68 market[4].

Highlight

"The increasing cancer cases are expected to boost demand for nuclear imaging, which favors the gallium-68 market progress," according to the International Agency for Research on Cancer (IARC)[1].

Key Takeaways

• The gallium-68 market is projected to grow significantly, driven by the increasing prevalence of prostate cancer and neuroendocrine tumors.
• The oncology segment, particularly prostate cancer diagnosis, is the largest and fastest-growing segment.
• North America dominates the market due to advanced healthcare infrastructure and technological advancements.
• The Asia Pacific region offers substantial growth opportunities.
• Key players are investing in R&D to expand applications and improve delivery systems.
• The short half-life of gallium-68 is a significant challenge.

Frequently Asked Questions (FAQs)

1. What is the primary use of Gallium Ga-68 gozetotide? Gallium Ga-68 gozetotide is primarily used for the diagnosis of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer through positron emission tomography (PET) imaging[2].

2. What is the projected market value of the gallium-68 market by 2030? The gallium-68 market is projected to reach USD 1,070.34 million by 2030[1].

3. What are the key drivers of the gallium-68 market growth? Key drivers include the increasing prevalence of prostate cancer and neuroendocrine tumors, advancements in nuclear medicine, and the growing use of nuclear imaging techniques[1][4].

4. Which region holds the largest market share for gallium-68? North America holds the largest market share for gallium-68, driven by advanced healthcare infrastructure and technological advancements[1].

5. What is the half-life of Gallium-68? Gallium-68 has a half-life of 68 minutes[2][5].

Sources Cited:

1. The Insight Partners - Gallium-68 Market Forecast to 2030 | Size, Share, Growth
2. DrugBank - Ga 68 PSMA-11: Uses, Interactions, Mechanism of Action
3. SNS Insider - Radiopharmaceuticals Market Size, Trends, Opportunities, 2032
4. Transparency Market Research - Gallium-68 Market Survey Report 2031
5. FDA - GALLIUM GA 68 GOZETOTIDE Injection Label[1][2][4][5]