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Last Updated: December 22, 2024

ULTRATAG Drug Patent Profile


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Which patents cover Ultratag, and what generic alternatives are available?

Ultratag is a drug marketed by Curium and is included in one NDA.

The generic ingredient in ULTRATAG is technetium tc-99m red blood cell kit. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m red blood cell kit profile page.

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Summary for ULTRATAG
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in ULTRATAG?ULTRATAG excipients list
DailyMed Link:ULTRATAG at DailyMed
Drug patent expirations by year for ULTRATAG

US Patents and Regulatory Information for ULTRATAG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Curium ULTRATAG technetium tc-99m red blood cell kit INJECTABLE;INJECTION 019981-001 Jun 10, 1991 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

ULTRATAG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for UltraTag

Introduction

UltraTag is a prominent kit used in nuclear medicine for the in vitro labeling of red blood cells (RBCs) with Technetium-99m ((^{99m})Tc). This article delves into the market dynamics and financial trajectory of UltraTag, highlighting its advantages, challenges, and the economic factors influencing its use.

Market Position and Competitors

UltraTag is one of the leading products in the market for RBC labeling, competing primarily with Gluceptate and Pyrophosphate kits. Here are some key points about its market position:

Advantages of UltraTag

  • High Labeling Efficiency (LE): UltraTag stands out for its high LE, consistently above 98%, and stability over 6 hours at both room temperature and 37°C[1][2].
  • Ease of Use: The UltraTag procedure is streamlined, requiring fewer materials and less time compared to Gluceptate and Pyrophosphate kits. It needs only 1-4 mL of blood, making it less cumbersome for patients and technologists[2].
  • Diagnostic Quality: UltraTag images have lower background noise, resulting in better diagnostic quality, particularly in cases requiring finer discrimination from background, such as gastrointestinal bleeding studies[2].

Challenges and Limitations

  • Cost: UltraTag is the most expensive option, priced at $125 per vial, which is not fully reimbursed through Canadian health insurance. This high cost can be a significant barrier in a managed care environment[2].
  • Availability of Alternatives: Gluceptate and Pyrophosphate kits, although less expensive ($20 and $80 per vial, respectively), offer similar LEs and are often preferred for cost savings. However, Pyrophosphate kits have been discontinued in Canada, making Gluceptate a more viable alternative[1][2].

Financial Trajectory

The financial trajectory of UltraTag is influenced by several factors, including its high cost, reimbursement policies, and the availability of cheaper alternatives.

Cost and Reimbursement

  • High Cost: The significant cost of UltraTag kits, at $125 per vial, makes it less attractive in cost-sensitive healthcare environments. This cost is particularly burdensome since it is not fully reimbursed through Canadian health insurance[2].
  • Reimbursement Policies: The lack of full reimbursement for UltraTag kits can limit its adoption, especially when cheaper alternatives like Gluceptate kits are available and reimbursed[2].

Market Demand and Usage

  • Specific Use Cases: Despite the high cost, UltraTag is reserved for cases that require high-quality images and quick procedures, such as gastrointestinal bleeding studies, difficult patients like children, and urgent or unexpected cases[2].
  • Patient and Technologist Preferences: The ease of use and minimal patient discomfort associated with UltraTag make it a preferred choice in certain clinical scenarios, even if it means higher costs[2].

Economic Impact on Healthcare

The economic impact of UltraTag on healthcare is multifaceted, involving both direct costs and indirect benefits.

Direct Costs

  • Kit Costs: The high cost of UltraTag kits directly affects the budget of healthcare institutions. For example, if a hospital performs numerous RBC labeling procedures, the cumulative cost can be substantial[2].
  • Reimbursement and Budgeting: Healthcare providers must balance the cost of UltraTag kits with the available budget and reimbursement policies, which can influence the choice of labeling method[2].

Indirect Benefits

  • Diagnostic Accuracy: The superior diagnostic quality of UltraTag images can lead to more accurate diagnoses and potentially better patient outcomes, which can have long-term economic benefits by reducing the need for repeat procedures or further diagnostic tests[2].
  • Efficiency and Time Savings: The streamlined procedure and shorter labeling time of UltraTag can save time for both patients and technologists, improving the overall efficiency of nuclear medicine departments[2].

Case Studies and Clinical Implications

Several case studies highlight the clinical implications and unique challenges associated with UltraTag.

Unusual Uptake Cases

  • A case study reported unusual liver and bone marrow uptake when using blood from a transfusion bag for labeling with UltraTag. This underscores the importance of adhering to standard preparation procedures and performing radiopharmaceutical quality control[4].

Use of Anticoagulants

  • Research on the use of heparin in UltraTag kits indicates that while the kits' anticoagulant properties are effective, heparin may be necessary to prevent macroscopic clots, especially in certain clinical scenarios. This has significant implications for patient safety and the accuracy of the study[5].

Market Trends and Future Outlook

The market for RBC labeling kits is influenced by several trends and factors that will shape the future of UltraTag.

Competitive Landscape

  • The discontinuation of Pyrophosphate kits in Canada and the single-sourcing of Gluceptate kits make UltraTag one of the few premium options available. However, its high cost remains a significant competitive disadvantage[1][2].

Regulatory and Reimbursement Changes

  • Changes in reimbursement policies and regulatory approvals can significantly impact the market dynamics. For instance, if reimbursement policies become more favorable, the adoption of UltraTag could increase[2].

Technological Advancements

  • Future technological advancements could lead to more cost-effective and efficient labeling methods, potentially challenging UltraTag's market position. However, any new technology would need to match or exceed UltraTag's high LE and diagnostic quality[2].

Key Takeaways

  • High Labeling Efficiency: UltraTag offers the highest LE and best diagnostic quality among RBC labeling kits.
  • Cost Considerations: Despite its advantages, UltraTag is the most expensive option and not fully reimbursed in some regions.
  • Specific Use Cases: UltraTag is preferred for cases requiring high-quality images and quick procedures.
  • Clinical Implications: Adherence to standard procedures and quality control is crucial to avoid unusual uptake and ensure patient safety.
  • Market Trends: The competitive landscape, reimbursement policies, and technological advancements will continue to influence the market dynamics of UltraTag.

FAQs

Q: What are the main advantages of using UltraTag for RBC labeling?

A: UltraTag offers high labeling efficiency (>98%), ease of use, and superior diagnostic image quality. It requires less blood (1-4 mL) and has a streamlined procedure compared to other kits[2].

Q: Why is UltraTag more expensive than other RBC labeling kits?

A: UltraTag is priced at $125 per vial, which is significantly higher than Gluceptate ($20 per vial) and Pyrophosphate kits ($80 per vial). This high cost is partly due to its advanced technology and superior performance[2].

Q: Are there any specific clinical scenarios where UltraTag is preferred?

A: Yes, UltraTag is preferred for cases requiring finer discrimination from background, such as gastrointestinal bleeding studies, difficult patients like children, and urgent or unexpected cases[2].

Q: How does the use of heparin affect the UltraTag procedure?

A: The use of heparin in UltraTag kits can help prevent macroscopic clots, although the kits' anticoagulant properties are generally effective. Heparin is particularly important in certain clinical scenarios to ensure patient safety and study accuracy[5].

Q: What are the implications of the discontinuation of Pyrophosphate kits in Canada for UltraTag?

A: The discontinuation of Pyrophosphate kits makes Gluceptate kits a more viable alternative to UltraTag. However, UltraTag remains a premium option for specific use cases despite its higher cost[1][2].

Sources

  1. Evaluation of available in vitro 99mTc-RBC labeling techniques. Journal of Nuclear Medicine, 55(Supplement 1), 2620.
  2. Evaluation of Available In Vitro 99m Tc-RBC Labeling Techniques. Journal of Nuclear Medicine Technology, 42(4), 243.
  3. The economics of follow-on drug research and development. PubMed.
  4. A Case Study Report | Journal of Nuclear Medicine Technology. Journal of Nuclear Medicine Technology, 32(1), 16.
  5. The Necessity of Using Heparin in an UltraTag™ RBC Kit when Labeling Red Blood Cells. ScholarWorks, Indiana University-Purdue University Indianapolis.

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