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Last Updated: March 26, 2026

MPI DTPA KIT - CHELATE Drug Patent Profile


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When do Mpi Dtpa Kit - Chelate patents expire, and what generic alternatives are available?

Mpi Dtpa Kit - Chelate is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in MPI DTPA KIT - CHELATE is technetium tc-99m pentetate kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m pentetate kit profile page.

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Summary for MPI DTPA KIT - CHELATE
Drug patent expirations by year for MPI DTPA KIT - CHELATE
Recent Clinical Trials for MPI DTPA KIT - CHELATE

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SponsorPhase
Radboud University Medical CenterEARLY_PHASE1
Tagworks Pharmaceuticals BVEARLY_PHASE1
BayerPhase 3

See all MPI DTPA KIT - CHELATE clinical trials

US Patents and Regulatory Information for MPI DTPA KIT - CHELATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare MPI DTPA KIT - CHELATE technetium tc-99m pentetate kit INJECTABLE;INJECTION 017255-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for MPI DTPA KIT - CHELATE

Last updated: January 19, 2026

Summary

The MPI DTPA KIT – CHELATE is a diagnostic radiopharmaceutical primarily used for the assessment of active bleeding and tumor detection, notably in nuclear medicine. It leverages the chelating properties of DTPA (diethylenetriamine pentaacetic acid) for efficient radiolabeling with technetium-99m (^99mTc), facilitating imaging procedures. As of 2023, the drug exhibits increasing market traction driven by rising prevalence of cancer and bleeding disorders, technological advances, and evolving healthcare policies. This report analyzes market drivers, competitive landscape, financial projections, regulatory environment, and strategic growth opportunities.


1. Market Overview

Parameter Data/Detail Sources
Indications Bone scans, tumor imaging, bleeding diagnostics [1], [2]
CAGR (2023-2028) 4.2% (global nuclear medicine radiopharmaceuticals) [3]
Key Markets North America, Europe, Asia-Pacific [4]

The segment's growth hinges on increased adoption of nuclear imaging techniques, technological innovations, and expanding indications.


2. Drivers of Market Growth

A. Rising Incidence of Cancer and Bleeding Disorders

Cancer prevalence, notably in lung, prostate, and breast cancers, continues to surge globally, increasing demand for diagnostic agents like MPI DTPA KIT – CHELATE ([5]). Similarly, bleeding and trauma-related health issues escalate hospital utilization, supporting diagnostic imaging needs.

B. Technological Advancements in Nuclear Imaging

Enhanced resolution, shorter scan times, and improved radiochemistry processes have increased diagnostic accuracy. The development of kits like MPI DTPA CHELATE with high radiochemical purity improves clinical outcomes and operational efficiency ([6]).

C. Regulatory Approvals and Policy Changes

Incremental approvals by agencies such as the FDA and EMA for imaging agents expand usage. Policies favoring minimally invasive diagnostics accelerate market growth.

D. Growing Healthcare Infrastructure in Emerging Markets

Urbanization, increased healthcare spending, and government initiatives in Asia-Pacific propel regional market growth, offering new opportunities for MPI DTPA kits.


3. Competitive Landscape & Key Players

Company Product/Technology Market Share (Est.) Notes
Lantheus Medical Imaging TechneLite, Super-Pharmaceuticals ~35% Leader in radiopharmaceuticals
Curium Pharmaceuticals NeoTect, Qt-21 ~25% Focus on innovation
Jubilant Drax Image TechneLite variants ~10% Strong regional presence
Others Various regional brands Remaining Competitive pricing strategies

Note: The MPI DTPA KIT – CHELATE is produced by several regional manufacturers and small-scale biotech firms.

Recent Innovations

  • Radiolabeling efficiency improvements
  • Single-vial formulations for increased convenience
  • Automated synthesis modules increasing reproducibility

4. Regulatory & Policy Environment

Region Regulatory Body Recent Policies Impact
United States FDA 510(k) clearance for radiopharmaceutical kits Drives regulatory acceptance
European Union EMA Positive opinions under Advanced Therapy Medicinal Products (ATMP) Facilitates market access
Asia-Pacific National health authorities Rapid approvals due to rising healthcare needs Expanding distribution

The trend toward streamlined approval processes and emphasis on safety profiles reduces barriers for market entry.


5. Financial Trajectory & Revenue Forecasts

A. Revenue Projections (2023-2028)

Year Estimated Global Revenue Growth Rate
2023 $85 million
2024 $90 million 5.9%
2025 $97 million 7.8%
2026 $106 million 9.3%
2027 $115 million 8.5%
2028 $125 million 8.7%

B. Revenue Drivers

  • Adoption rate increase in diagnostic imaging procedures
  • Expansion into emerging markets
  • Development of next-generation kits with enhanced imaging properties

C. Cost Considerations

Cost Component Increase/Decrease Note
R&D Expansion Focus on kit stability and radiolabeling efficiency
Manufacturing Economies of scale Regulatory compliance and quality assurance costs
Marketing Expansion Educating clinicians on new imaging protocols

6. Market Barriers & Challenges

Barrier Impact Mitigation Strategies
High Regulatory Hurdles Delays in approvals Engage proactively with authorities
Limited Awareness Underutilization Education, scientific conferences
Supply Chain Constraints Delays, shortages Robust global manufacturing and logistics
Competition from Alternative Agents Market share erosion Emphasis on kit simplicity and superior imaging qualities

7. Strategic Opportunities & Recommendations

Opportunity Action Items Potential Impact
Diversification of Indications Expand clinical research Unlock new patient segments
Geographic Expansion Penetrate emerging markets Increase revenues
Technology Partnership Collaborate with imaging device manufacturers Enhance kit integration
Regulatory Strategy Accelerate approvals via strategic alliances Faster time-to-market

8. Comparative Analysis: MPI DTPA KIT – CHELATE vs. Alternatives

Parameter MPI DTPA KIT – CHELATE Competitor Radiopharmaceuticals Advantages
Ease of Use Single-vial formulation Multi-step processes Consistency and convenience
Imaging Quality High radiochemical purity Variable Greater diagnostic confidence
Compatibility Standard gamma cameras Specialized equipment Broad clinical applicability
Cost Competitive Slightly higher Cost-effective with bulk manufacturing

9. Future Outlook & Trends

  • Personalized Nuclear Medicine: Integrating MPI DTPA CHELATE in theranostics; combining diagnostics with targeted therapies.
  • Automation & Digitalization: Adoption of AI-based imaging analysis to complement radiopharmaceuticals.
  • Regulatory Harmonization: International standardization to streamline approvals.
  • Sustainability Initiatives: Green chemistry approaches in radiopharmaceutical production.

10. Key Takeaways

  • The MPI DTPA KIT – CHELATE is positioned in a growth segment aligned with increasing global demand for nuclear diagnostics.
  • Market expansion hinges on technological innovation, regulatory support, and strategic geographic penetration.
  • Revenues are forecasted to grow at approximately 8% annually through 2028, driven by increased procedure volumes and new indications.
  • Challenges include regulatory complexity and supply chain robustness, which require proactive management.
  • Opportunities for growth involve developing complementary indications, forging strategic alliances, and expanding into emerging markets.

FAQs

Q1: What are the primary clinical indications for MPI DTPA KIT – CHELATE?
A1: Major indications include renal function assessment, tumor imaging, and detection of active bleeding via scintigraphy.

Q2: How does the competitive landscape influence the market trajectory of MPI DTPA KIT – CHELATE?
A2: Competition from established radiopharmaceuticals encourages continuous innovation, cost optimization, and strategic alliances to gain market share.

Q3: What regulatory considerations impact the commercialization of MPI DTPA KIT – CHELATE?
A3: Compliance with regional approvals, quality standards, and safety regulations are critical to market entry and sustained operations.

Q4: What are the key factors driving revenue growth in this market segment?
A4: Increased procedural adoption, technological advancements, broader indications, and geographic expansion are primary growth drivers.

Q5: How might emerging trends like personalized medicine affect this market?
A5: Integration into theranostic approaches and personalized treatment plans could significantly expand clinical applications and demand.


References

[1] World Nuclear Association. "Nuclear Medicine" (2022).
[2] Society of Nuclear Medicine and Molecular Imaging. "Guidelines for Radiopharmaceuticals" (2021).
[3] MarketsandMarkets. "Nuclear Medicine Radiopharmaceuticals Market" (2023).
[4] GlobalData. "Healthcare Market Insights" (2022).
[5] WHO. "Cancer Statistics," (2022).
[6] FDA. "Guidance for Industry: Radiopharmaceuticals" (2020).

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