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Last Updated: December 12, 2025

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

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

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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: August 2, 2025


Introduction

MPI DTPA KIT - CHELATE is a specialized pharmaceutical product used predominantly in diagnostic imaging and radiopharmaceutical procedures. It is a chelating agent facilitating the safe and effective administration of radiopharmaceuticals, integral to nuclear medicine applications. As the healthcare industry increasingly adopts personalized and minimally invasive diagnostic solutions, the market trajectory for MPI DTPA KIT - CHELATE is shaped by evolving technological, regulatory, and demographic factors. This analysis critically examines current market dynamics and forecasts its economic trajectory.


Market Overview and Key Drivers

Growing Demand for Nuclear Medicine Diagnostics
The global nuclear medicine market is witnessing robust growth, driven by rising incidences of cancer, cardiovascular diseases, and neurological disorders. MPI DTPA KIT - CHELATE, as a vital component in radiopharmaceutical protocols, benefits directly from this expanding healthcare segment. The World Health Organization (WHO) reports a steady increase in cancer prevalence, prompting enhanced use of diagnostic imaging that employs chelated radiotracers [1].

Advancements in Radiopharmaceutical Technology
Innovations in chelating agents, such as MPI DTPA, enhance the stability, bioavailability, and safety profiles of radiopharmaceuticals. The development of high-specific-activity DTPA chelates improves imaging precision, fostering increased clinical utility and acceptance in medical practice.

Regulatory Approvals and Quality Standards
Stringent regulatory pathways, notably in the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), influence market entry and growth. Products compliant with good manufacturing practices (GMP) and demonstrating safety and efficacy catalyze adoption by healthcare providers.

Increasing Awareness and Clinical Adoption
Physician awareness about the benefits of precise diagnostic techniques using chelates like MPI DTPA KIT enhances its prescription rates. Educational initiatives and clinical guidelines favoring nuclear imaging techniques further bolster demand.

Emerging Markets and Untapped Regions
Rapid healthcare infrastructure development in Asia-Pacific and Latin America presents significant opportunities. Rising investments in diagnostic facilities, coupled with government initiatives, facilitate market penetration for chelating kits.


Market Challenges and Competitive Landscape

High Cost and Complex Manufacturing
The production of chelating agents involves sophisticated processes with stringent quality controls, resulting in high manufacturing costs. These expenses translate into elevated product prices, sometimes limiting affordability in resource-constrained settings.

Regulatory Complexity
Navigating the complex regulatory environment for radiopharmaceuticals delays time-to-market and requires significant investment in compliance infrastructure. Variability in regional approval processes influences product availability and market access.

Competition from Alternative Chelates
Other chelating agents like DOTA and NOTA are competing alternatives in specific applications. The choice of chelate depends on factors such as stability, radiation half-life, and compatibility, challenging MPI DTPA KIT’s market share.

Limited Market Penetration in Low-Resource Settings
Infrastructure gaps and lack of trained personnel inhibit widespread adoption in developing regions, constraining the global growth potential of MPI DTPA KIT - CHELATE.


Financial Trajectory and Market Forecast

Historical Market Growth
The global market for chelating agents used in radiopharmaceuticals was valued at approximately USD 200 million in 2020, with an estimated compound annual growth rate (CAGR) of 6-8% over the past five years [2]. MPI DTPA KIT is a significant segment within this sector, increasingly adopted in diagnostic centers and research institutions.

Projected Market Growth (2023-2030)
Forecasts predict a continued CAGR of 8-10%, driven by increased nuclear medicine procedures and expanding application scopes. The introduction of novel, more stable chelate formulations and tailored kits augments market size. By 2030, the market for MPI DTPA KIT - CHELATE is projected to reach USD 400-500 million globally, assuming sustained technological and regulatory progress.

Regional Outlook
North America remains the dominant market, owing to advanced healthcare infrastructure and high diagnostic imaging adoption rates. Europe follows, with similar trends. The Asia-Pacific region is anticipated to register the fastest growth (CAGR 12-15%), driven by rising healthcare investments and demographic shifts.

Economic Impact and Revenue Streams
Pharmaceutical companies developing MPI DTPA kits benefit from high-margin sales, especially as the product reaches clinical adoption. Strategic partnerships with regional distributors and licensing agreements further diversify revenue avenues.


Strategic Outlook and Investment Opportunities

Investment in R&D
Innovating chelating agents with enhanced stability, shorter preparation time, and cost-effectiveness remains a priority. Developing ready-to-use kits aligned with personalized medicine trends can provide competitive advantages.

Regulatory Strategy Optimization
Streamlining approval processes through regulatory harmonization and engaging early with authorities accelerates market entry. Investment in quality systems ensures compliance and market confidence.

Market Expansion and Localization
Targeting emerging markets with tailored marketing strategies and local regulatory understanding enhances penetration. Establishing regional manufacturing hubs reduces logistical costs and improves supply chain resilience.

Partnerships and Collaborations
Collaborative ventures with healthcare providers, research institutions, and government agencies support product development and deployment, unlocking new applications and market segments.


Key Takeaways

  • Growing Diagnostic Demand: The expanding global incidence of cancer and cardiovascular diseases underpins increased MPI DTPA KIT utilization.

  • Innovation and Differentiation: Advancements in chelation technology foster product competitiveness, with safety and stability as key differentiators.

  • Regulatory Navigation: Regulatory excellence accelerates commercialization, particularly in diverse markets with varying approval frameworks.

  • Global Market Opportunities: Asia-Pacific's rapid healthcare infrastructure growth presents significant upside, offsetting slower penetration in resource-limited regions.

  • Strategic Investment: Focused R&D, regulatory engagement, and regional partnerships are essential to capitalize on projected market growth, forecasted to reach USD 500 million by 2030.


FAQs

1. What are MPI DTPA KIT - CHELATE’s primary clinical applications?
MPI DTPA KIT - CHELATE is mainly used in the preparation of radiopharmaceuticals for diagnostic imaging in nuclear medicine, particularly for detecting brain tumors, renal functions, and bone scans.

2. How does technological innovation impact the market for chelating agents like MPI DTPA?
Innovation improves chelate stability and ease of preparation, increasing clinical utility, safety, and user convenience, thereby expanding market adoption.

3. What regulatory hurdles affect the commercialization of MPI DTPA KIT - CHELATE?
Regulatory approval involves demonstrating safety, efficacy, and manufacturing quality, often entailing lengthy review processes that vary across regions.

4. What are the main competitive alternatives to MPI DTPA KIT in nuclear medicine?
Alternatives include other chelating agents such as DOTA, NOTA, and TETA, each with specific applications and performance attributes.

5. How does regional economic development influence the market trajectory?
Developed regions exhibit higher adoption rates due to robust healthcare infrastructure, whereas emerging markets present growth opportunities driven by increasing healthcare investments.


References

[1] World Health Organization. Global Cancer Statistics. 2022.
[2] MarketsandMarkets. Cheating Agents in Radiopharmaceuticals Market - Global Forecast to 2025.

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