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Last Updated: December 23, 2024

RUBIDIUM CHLORIDE RB-82 - Generic Drug Details


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What are the generic sources for rubidium chloride rb-82 and what is the scope of freedom to operate?

Rubidium chloride rb-82 is the generic ingredient in two branded drugs marketed by Bracco and Jubilant, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for RUBIDIUM CHLORIDE RB-82
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 7
Patent Applications: 66
What excipients (inactive ingredients) are in RUBIDIUM CHLORIDE RB-82?RUBIDIUM CHLORIDE RB-82 excipients list
DailyMed Link:RUBIDIUM CHLORIDE RB-82 at DailyMed
Pharmacology for RUBIDIUM CHLORIDE RB-82

US Patents and Regulatory Information for RUBIDIUM CHLORIDE RB-82

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant RUBY-FILL rubidium chloride rb-82 SOLUTION;INTRAVENOUS 202153-001 Sep 30, 2016 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bracco CARDIOGEN-82 rubidium chloride rb-82 INJECTABLE;INJECTION 019414-001 Dec 29, 1989 RX No No ⤷  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

Expired US Patents for RUBIDIUM CHLORIDE RB-82

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco CARDIOGEN-82 rubidium chloride rb-82 INJECTABLE;INJECTION 019414-001 Dec 29, 1989 4,400,358 ⤷  Subscribe
Bracco CARDIOGEN-82 rubidium chloride rb-82 INJECTABLE;INJECTION 019414-001 Dec 29, 1989 4,562,829 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

RUBIDIUM CHLORIDE RB-82 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rubidium Chloride Rb-82

Introduction to Rubidium Chloride Rb-82

Rubidium Chloride Rb-82 is a radiopharmaceutical diagnostic agent used primarily for Positron Emission Tomography (PET) imaging of the myocardium. It is indicated for evaluating regional myocardial perfusion in adult patients with suspected or existing coronary artery disease[4][5].

Market Drivers

Increasing Demand in Nuclear Cardiology

The demand for Rubidium Chloride Rb-82 is driven by the growing need for accurate and reliable diagnostic tools in nuclear cardiology. With advancements in PET/CT systems and increased production capabilities of strontium-82, the number of patients undergoing Rb-82 PET imaging has significantly increased over the past decade[3].

Technological Advancements

Technological improvements, such as semiconductor detector SPECT scanners, novel collimator designs, and iterative reconstruction methods, have enhanced the diagnostic accuracy and efficiency of Rb-82 PET imaging. These advancements have made Rb-82 a preferred choice for myocardial perfusion imaging, contributing to its market growth[3].

Clinical Advantages

Rb-82 PET imaging offers several clinical advantages, including the ability to accurately quantify myocardial blood flow (MBF) and assess coronary flow reserve. These capabilities are crucial for diagnosing and managing coronary artery disease, further driving the demand for Rubidium Chloride Rb-82[3].

Market Segmentation

Product Type

The market for Rubidium Chloride Rb-82 is segmented based on the product type, which includes the Rb-82 generator and the elution system. The RUBY-FILLĀ® generator, for example, contains accelerator-produced strontium-82 that decays to Rb-82, and it is used in conjunction with a specialized elution system to deliver accurate doses of Rb-82 chloride[5].

Geographic Distribution

Geographically, the market is segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America, particularly the United States, is a significant market due to the high prevalence of coronary artery disease and the advanced healthcare infrastructure[1].

Financial Trajectory

Revenue Growth

The revenue from Rubidium Chloride Rb-82 is expected to grow significantly due to the increasing demand for advanced diagnostic tools in cardiology. The market has seen substantial growth in recent years, driven by the expanding use of PET imaging in clinical settings. For instance, the number of patients injected with Rb-82 in the USA has dramatically increased, although it still represents a small percentage compared to other diagnostic agents like 99mTc-sestamibi and 99mTc-tetrofosmin[3].

Cost and Pricing

The cost of Rb-82 examinations is a critical factor in its financial trajectory. While the initial cost of the generator and elution system is high, the ability to use a single generator for 28-42 days (and potentially up to 60 days in the future) helps in reducing the cost per patient. This extended usage period is expected to make Rb-82 PET imaging more economically viable, contributing to its market growth[3][5].

Challenges and Restraints

Availability and Cost

Despite the growing demand, the availability and high cost of Rubidium Chloride Rb-82 are significant challenges. The production and distribution of Rb-82 generators and elution systems are complex and costly, which can limit market expansion. Additionally, the short half-life of Rb-82 (75 seconds) necessitates the use of specialized elution systems, adding to the overall cost[1][5].

Regulatory and Safety Considerations

The use of radiopharmaceuticals like Rb-82 is heavily regulated, and there are serious warnings and precautions associated with its administration. It must be used by qualified health professionals, and adequate diagnostic and treatment facilities must be available. These regulatory and safety considerations can impact the market's financial trajectory by influencing the adoption rate and usage patterns[5].

Key Applications

Myocardial Perfusion Imaging

The primary application of Rubidium Chloride Rb-82 is in myocardial perfusion imaging under rest or pharmacologic stress conditions. This application is crucial for diagnosing and assessing coronary artery disease, making it a vital tool in nuclear cardiology[4][5].

Clinical Utility

Rb-82 PET imaging provides daily availability in nuclear cardiology departments, allowing for the injection of up to 10-15 patients per day. This frequent usage highlights its clinical utility and contributes to its market demand[3].

Market Trends

Technological Innovations

Continuous technological innovations in PET imaging and the development of new generators and elution systems are expected to drive the market forward. These innovations aim to improve the efficiency, accuracy, and cost-effectiveness of Rb-82 PET imaging[3].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure, particularly in regions like Asia-Pacific, is expected to increase the demand for advanced diagnostic tools like Rb-82 PET imaging. Government initiatives, such as India's plans to enhance telecommunication infrastructure, indirectly support the growth of the rubidium market by increasing the demand for specialty glasses used in fiber optics[1].

Key Takeaways

  • Growing Demand: The market for Rubidium Chloride Rb-82 is driven by increasing demand in nuclear cardiology and technological advancements.
  • Clinical Advantages: Rb-82 PET imaging offers accurate quantification of myocardial blood flow and assessment of coronary flow reserve.
  • Financial Growth: Revenue is expected to grow due to expanding use in clinical settings, despite high initial costs.
  • Challenges: Availability, cost, and regulatory considerations are significant challenges.
  • Key Applications: Primarily used for myocardial perfusion imaging in diagnosing and assessing coronary artery disease.

FAQs

What is Rubidium Chloride Rb-82 used for?

Rubidium Chloride Rb-82 is used for Positron Emission Tomography (PET) imaging of the myocardium to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease[4].

How is Rubidium Chloride Rb-82 produced?

Rubidium Chloride Rb-82 is produced through the decay of strontium-82 in a generator. The generator is eluted with saline to produce a sterile, non-pyrogenic solution of Rb-82 chloride[5].

What are the advantages of Rb-82 PET imaging?

Rb-82 PET imaging offers accurate quantification of myocardial blood flow and assessment of coronary flow reserve. It also provides daily availability in nuclear cardiology departments, allowing for multiple patient injections per day[3].

What are the challenges associated with the use of Rubidium Chloride Rb-82?

The challenges include high cost, limited availability, and the need for specialized elution systems due to the short half-life of Rb-82. Additionally, there are regulatory and safety considerations that must be adhered to[1][5].

How does the cost of Rb-82 examinations impact its market growth?

The cost of Rb-82 examinations is high, but the ability to use a single generator for an extended period helps reduce the cost per patient. This makes Rb-82 PET imaging more economically viable, contributing to its market growth[3][5].

Sources

  1. BlueQuark Research & Consulting: Global Rubidium Market.
  2. University of New Mexico: Rubidium Rb 82 Generator.
  3. Frontiers in Medicine: Story of Rubidium-82 and Advantages for Myocardial Perfusion Imaging.
  4. DrugBank: Rubidium chloride Rb-82.
  5. DraxImage: RUBY-FILLĀ® (Rubidium Rb 82 Generator) and Elution System.

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