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Last Updated: December 22, 2024

GALLIUM DOTATATE GA-68 - Generic Drug Details


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What are the generic sources for gallium dotatate ga-68 and what is the scope of patent protection?

Gallium dotatate ga-68 is the generic ingredient in one branded drug marketed by Aaa Usa Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Gallium dotatate ga-68 has thirty-two patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for GALLIUM DOTATATE GA-68
International Patents:32
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 16
DailyMed Link:GALLIUM DOTATATE GA-68 at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GALLIUM DOTATATE GA-68
Generic Entry Date for GALLIUM DOTATATE GA-68*:
Constraining patent/regulatory exclusivity:
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 DOTATATE GA-68

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

SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
Peking Union Medical College HospitalEarly Phase 1
First Affiliated Hospital of Fujian Medical UniversityEarly Phase 1

See all GALLIUM DOTATATE GA-68 clinical trials

US Patents and Regulatory Information for GALLIUM DOTATATE GA-68

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aaa Usa Inc NETSPOT gallium dotatate ga-68 POWDER;INTRAVENOUS 208547-001 Jun 1, 2016 RX Yes Yes 9,375,498 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for GALLIUM DOTATATE GA-68

Country Patent Number Title Estimated Expiration
European Patent Office 2742017 PROCÉDÉ POUR LA PRÉPARATION DE COMPLEXES DE 68GA (PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA) ⤷  Subscribe
Israel 230904 תהליך להכנת קומפלקסים של גאליום -68 (Process for the preparation of complexes of 68ga) ⤷  Subscribe
Denmark 2742017 ⤷  Subscribe
India 1897CHN2014 ⤷  Subscribe
European Patent Office 3718991 PROCÉDÉ POUR LA PRÉPARATION DE COMPLEXES DE 68GA (PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA) ⤷  Subscribe
Mexico 370081 PROCEDIMIENTO PARA LA PREPARACION DE COMPLEJOS DE 68GA. (PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA.) ⤷  Subscribe
Brazil 122020011908 PROCESSO PARA A PREPARAÇÃO DE COMPLEXOS DE 68GA ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

GALLIUM DOTATATE GA-68 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gallium-68 Dotatate

Market Overview

The global gallium-68 market is experiencing significant growth, driven by several key factors. Here are the main dynamics and financial projections for gallium-68 dotatate.

Drivers of the Market

Increasing Prevalence of Tumors and Cancer

The rise in the prevalence of tumors and cancer has significantly increased the demand for gallium-68, particularly in clinical PET imaging facilities. Gallium-68 dotatate is widely used for diagnosing and managing neuroendocrine tumors (NETs), which are becoming more prevalent[1].

Advancements in Nuclear Medicine

Advancements in nuclear medicine, including the development of new radiopharmaceuticals and improved PET/CT imaging technologies, are driving the growth of the gallium-68 market. Gallium-68 dotatate has emerged as a preferred agent due to its high affinity for somatostatin-2 receptors, which are often overexpressed in NETs[3].

Economic Growth and Healthcare Improvements

The Asia Pacific region, particularly countries like China and India, is witnessing constant economic growth and improvements in healthcare facilities. This has led to increased consumer awareness and higher incomes, resulting in a greater demand for advanced diagnostic tools like gallium-68 dotatate[1].

Regulatory Approvals

The FDA approval of gallium-68 dotatate in June 2016 has been a significant milestone. This approval has expanded its use in the U.S. market, contributing to the overall growth of the gallium-68 market[3].

Market Segmentation

By Application

The oncology segment accounts for a major share of the gallium-68 market. Gallium-68 dotatate is primarily used for imaging neuroendocrine tumors, which are a subset of oncological conditions. Other applications include cardiology, neurology, and urology, although oncology remains the dominant segment[1].

By End User

Hospitals and diagnostic centers are the primary end users of gallium-68 dotatate. The convenience and dependability of gallium-68 generators have made it accessible to hundreds of nuclear pharmacies across various regions[5].

By Region

North America is expected to dominate the gallium-68 market due to rapid advancements in PET systems and increased access to healthcare. However, the Asia Pacific region is also growing rapidly due to economic and healthcare improvements[1].

Financial Projections

Market Size and Growth Rate

The global gallium-68 market was valued at approximately US$ 100 million in 2020 and is projected to reach US$ 200 million by 2031. This represents a compound annual growth rate (CAGR) of about 8% from 2021 to 2031[1].

Revenue Streams

The revenue growth is anticipated to come from the increasing adoption of gallium-68 dotatate in various medical disciplines, including oncology, cardiology, and neurology. Newer applications and ongoing research for therapeutic uses of gallium-68 are also expected to contribute to the revenue streams[1].

Competitive Landscape

Key Players

Major players in the global gallium-68 market include Siemens Healthineers AG, ITM Isotopen Technologien München AG, Advanced Accelerator Applications (a Novartis AG Company), and Telix Pharmaceuticals. These companies are adopting inorganic growth strategies, such as partnerships and acquisitions, to expand their market presence[1].

Technological and Clinical Advantages

Diagnostic Accuracy

Gallium-68 dotatate has been shown to be significantly superior to traditional gamma imaging techniques like indium-111 DTPA-octreotide. It offers high diagnostic accuracy and is considered the most sensitive method for detecting, staging, and monitoring well-differentiated NETs[2].

Radiation Properties

The radiopharmaceutical has good radiation properties, including a half-life of 68 minutes, which is suitable for PET imaging. Although it has a higher positron emission energy compared to fluorine-18, its use is optimized through advanced PET/CT technologies[4].

Convenience and Accessibility

Gallium-68 is obtained using compact and readily available generators, making it locally accessible at numerous nuclear pharmacies. This convenience and dependability are key factors driving its adoption[5].

Challenges and Opportunities

Research and Development

Ongoing research activities for new applications of gallium-68, including therapeutic uses, are expected to create new opportunities for the market. However, the higher positron emission energy of gallium-68 compared to fluorine-18 could potentially affect spatial resolution, presenting a challenge that needs to be addressed through technological advancements[1][4].

Regulatory and Safety Considerations

The safety and efficacy of gallium-68 dotatate have been established, but there are specific guidelines for administration, particularly in pediatric and lactating patients. Ensuring compliance with these guidelines is crucial for maintaining market trust and safety standards[2][3].

Regional Insights

North America

North America is expected to dominate the gallium-68 market due to rapid advancements in PET systems and increased access to healthcare. The U.S. and Canada are key markets, with significant investments in nuclear medicine and diagnostic imaging[1].

Europe

Europe is also a significant market, driven by the rising use of gallium-68 radiopharmaceuticals in diagnosing diseases related to cardiology, respiratory, and urology. The region benefits from the availability of FDA-approved versions of gallium-68 radiopharmaceuticals[1].

Asia Pacific

The Asia Pacific region is witnessing rapid growth due to economic improvements, increased consumer awareness, and the significance of nuclear medicine in various medical disciplines. Countries like China and India offer substantial opportunities for market expansion[1].

Key Takeaways

  • The global gallium-68 market is projected to reach US$ 200 million by 2031, growing at a CAGR of about 8% from 2021 to 2031.
  • The market is driven by the increasing prevalence of tumors and cancer, advancements in nuclear medicine, and economic growth in the Asia Pacific region.
  • Gallium-68 dotatate is primarily used in oncology for diagnosing and managing neuroendocrine tumors.
  • Key players are adopting inorganic growth strategies to expand their market presence.
  • Ongoing research for new applications and therapeutic uses of gallium-68 is expected to create new market opportunities.

FAQs

What is the primary use of gallium-68 dotatate?

Gallium-68 dotatate is primarily used for diagnosing and managing neuroendocrine tumors (NETs) through positron emission tomography (PET) imaging.

Which region is expected to dominate the gallium-68 market?

North America is expected to dominate the gallium-68 market due to rapid advancements in PET systems and increased access to healthcare.

What are the key drivers of the gallium-68 market?

The key drivers include the increasing prevalence of tumors and cancer, advancements in nuclear medicine, and economic growth in the Asia Pacific region.

Who are the major players in the gallium-68 market?

Major players include Siemens Healthineers AG, ITM Isotopen Technologien München AG, Advanced Accelerator Applications (a Novartis AG Company), and Telix Pharmaceuticals.

What are the advantages of gallium-68 dotatate over traditional imaging techniques?

Gallium-68 dotatate offers high diagnostic accuracy, is more sensitive than traditional gamma imaging techniques, and has good radiation properties suitable for PET imaging.

Sources

  1. Transparency Market Research: Gallium-68 Market Survey Report 2031.
  2. American College of Radiology: Practice Parameter for the Performance of Gallium-68 and Copper-64 DOTATATE PET/CT Imaging for Neuroendocrine Tumors.
  3. DrugBank: Dotatate gallium Ga-68: Uses, Interactions, Mechanism of Action.
  4. MDPI: The First FDA-Approved 68 Ga-Radiopharmaceutical for PET Imaging.
  5. Cardinal Health: Gallium-68 Radiopharmaceuticals.

More… ↓

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