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Last Updated: December 22, 2024

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GALLIUM GA 68 EDOTREOTIDE Drug Patent Profile


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When do Gallium Ga 68 Edotreotide patents expire, and when can generic versions of Gallium Ga 68 Edotreotide launch?

Gallium Ga 68 Edotreotide is a drug marketed by Uihc Pet Imaging and is included in one NDA.

The generic ingredient in GALLIUM GA 68 EDOTREOTIDE is gallium ga-68 edotreotide. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium ga-68 edotreotide profile page.

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Summary for GALLIUM GA 68 EDOTREOTIDE
Drug patent expirations by year for GALLIUM GA 68 EDOTREOTIDE
Recent Clinical Trials for GALLIUM GA 68 EDOTREOTIDE

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SponsorPhase
Jiangsu HengRui Medicine Co., Ltd.Phase 3
National Cancer Institute (NCI)Early Phase 1
M.D. Anderson Cancer CenterEarly Phase 1

See all GALLIUM GA 68 EDOTREOTIDE clinical trials

US Patents and Regulatory Information for GALLIUM GA 68 EDOTREOTIDE

GALLIUM GA 68 EDOTREOTIDE is protected by zero US patents and four FDA Regulatory Exclusivities.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Uihc Pet Imaging GALLIUM GA 68 EDOTREOTIDE gallium ga-68 edotreotide SOLUTION;INTRAVENOUS 210828-001 Aug 21, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Uihc Pet Imaging GALLIUM GA 68 EDOTREOTIDE gallium ga-68 edotreotide SOLUTION;INTRAVENOUS 210828-001 Aug 21, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

GALLIUM GA 68 EDOTREOTIDE Market Analysis and Financial Projection Experimental

Gallium-68 Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Gallium-68

Gallium-68 is a positron-emitting radioisotope widely used in medical diagnostic procedures, particularly in positron emission tomography (PET) imaging. Its applications are diverse, ranging from prostate cancer imaging to the diagnosis of neuroendocrine tumors.

Market Size and Growth

The global gallium-68 market was valued at approximately US$ 100 million in 2020 and is projected to expand at a compound annual growth rate (CAGR) of around 8% from 2021 to 2031, reaching an estimated value of US$ 200 million by 2031[1][4].

Key Drivers of the Market

Rise in Prevalence of Cancer

The increasing prevalence of cancer, particularly prostate cancer and neuroendocrine tumors, is a significant driver of the gallium-68 market. According to the GLOBOCAN 2020 report, around 1.4 million new cases of prostate cancer and 375,000 deaths were reported globally in 2020[1].

Advancements in Nuclear Medicine

Advancements in nuclear medicine, including the development of new radiopharmaceuticals and molecular imaging techniques, are propelling the market forward. The sensitivity and specificity of gallium-68 radiopharmaceuticals have been evaluated in numerous clinical trials, further boosting their adoption[1][4].

Improving Healthcare Infrastructure

The rapid improvement in healthcare infrastructure, especially in the Asia Pacific region, is creating significant opportunities for the gallium-68 market. This region is expected to expand at a CAGR of around 10% from 2021 to 2031 due to the rising importance of nuclear medicine in various medical disciplines[1][4].

Regional Analysis

North America

North America is projected to dominate the global gallium-68 market during the forecast period. The region's advanced healthcare infrastructure, rapid introduction of advanced PET systems, and high prevalence of neuroendocrine tumors are key factors driving this dominance[1][3][4].

Europe

Europe is also expected to see significant growth, driven by the increasing use of gallium-68 radiopharmaceuticals in diagnosing diseases related to cardiology, respiratory, and urology. The market in Europe is anticipated to expand at a high CAGR in the near future[1][4].

Asia Pacific

The Asia Pacific region is witnessing rapid economic growth and improvements in healthcare facilities, making it a promising market for gallium-68. The region's growing significance in nuclear medicine and increasing research & development activities are expected to drive market growth[1][4].

Market Segmentation

By Application

The global gallium-68 market is segmented into oncology, neurology, cardiology, and others. The oncology segment, which includes prostate cancer and neuroendocrine tumors, dominated the market in 2020 and is expected to continue this trend during the forecast period[1][3][4].

By End User

The market is also categorized by end users into hospitals, diagnostic and imaging centers, and others. Hospitals held the largest market share in 2022 and are anticipated to register the highest CAGR during the forecast period[3].

Key Players and Growth Strategies

Key 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 engaged in research and development to develop novel products and expand their product offerings and customer base. For instance, ITM received marketing authorization for the ready-to-use radiopharmaceutical TOCscan (68Ga-Edotreotide) in several European countries in 2018[1][4].

Challenges and Limitations

Short Shelf-Life

One of the significant challenges facing the gallium-68 market is the short shelf-life of the radioisotope, which is approximately 68 minutes. This necessitates careful logistics and timing in its production and use[3].

Regulatory and Safety Considerations

The use of gallium-68 radiopharmaceuticals, such as Gallium Ga 68 Edotreotide Injection, involves careful consideration of safety and regulatory aspects. For example, the administration of these radiopharmaceuticals to pregnant women requires careful evaluation due to the potential for fetal harm[2].

Clinical Significance and Outcomes

Diagnostic Accuracy

Gallium-68 based radiopharmaceuticals, such as Gallium Ga 68 Edotreotide Injection, have shown high diagnostic accuracy in localizing somatostatin receptor-positive neuroendocrine tumors. Studies have demonstrated positive percent agreement and negative percent agreement rates that highlight the efficacy of these agents in clinical settings[2].

Prognostic Significance

Research has also shown that parameters obtained from gallium-68 PET/CT scans, such as SUVmax sstr and RTV sstr, can predict outcomes in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET) undergoing surgery[5].

Financial Trajectory

The gallium-68 market is expected to grow significantly over the next decade. Here are some key financial projections:

  • 2020: The market was valued at approximately US$ 100 million[1][4].
  • 2022: The market was valued at US$ 782.36 million[3].
  • 2030: The market is projected to reach US$ 1,070.34 million, growing at a CAGR of 4.0% from 2022 to 2030[3].
  • 2031: The market is expected to expand to US$ 200 million, growing at a CAGR of around 8% from 2021 to 2031[1][4].

Key Takeaways

  • The gallium-68 market is driven by the increasing prevalence of cancer, advancements in nuclear medicine, and improvements in healthcare infrastructure.
  • North America and Europe are key regions, with the Asia Pacific region offering significant growth opportunities.
  • The oncology segment dominates the market, with a focus on prostate cancer and neuroendocrine tumors.
  • Key players are investing in research and development to expand their product offerings.
  • Despite the short shelf-life of gallium-68, its diagnostic accuracy and prognostic significance make it a valuable tool in clinical settings.

FAQs

What is the primary use of gallium-68 in medical diagnostics?

Gallium-68 is primarily used in positron emission tomography (PET) imaging for the localization of somatostatin receptor-positive neuroendocrine tumors and prostate cancer.

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

North America is projected to dominate the global gallium-68 market during the forecast period due to advanced healthcare infrastructure and the rapid introduction of advanced PET systems.

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

The key drivers include the rise in prevalence of cancer, advancements in nuclear medicine, and improvements in healthcare infrastructure, especially in the Asia Pacific region.

Which segment holds the largest market share in the gallium-68 market?

The oncology segment, which includes prostate cancer and neuroendocrine tumors, holds the largest market share and is expected to continue this trend during the forecast period.

What is the projected CAGR of the gallium-68 market from 2021 to 2031?

The gallium-68 market is projected to expand at a CAGR of around 8% from 2021 to 2031.

Sources:

  1. BioSpace: Gallium-68 Market: Enhanced Research on Applications of Gallium-68 Reveals New Opportunities.
  2. FDA: GALLIUM Ga 68 EDOTREOTIDE INJECTION.
  3. The Insight Partners: Gallium-68 Market Forecast to 2030 | Size, Share, Growth.
  4. Transparency Market Research: Gallium-68 Market Survey Report 2031.
  5. PubMed: Ga-68-Edotreotide Positron Emission Tomography/Computed Tomography.

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