MPI DMSA KIDNEY REAGENT Drug Patent Profile

Which patents cover Mpi Dmsa Kidney Reagent, and what generic alternatives are available?

Mpi Dmsa Kidney Reagent is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in MPI DMSA KIDNEY REAGENT is technetium tc-99m succimer kit. There are four drug master file entries for this compound. Additional details are available on the technetium tc-99m succimer kit profile page.

Summary for MPI DMSA KIDNEY REAGENT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	37
DailyMed Link:	MPI DMSA KIDNEY REAGENT at DailyMed

US Patents and Regulatory Information for MPI DMSA KIDNEY REAGENT

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 DMSA KIDNEY REAGENT	technetium tc-99m succimer kit	INJECTABLE;INJECTION	017944-001	May 18, 1982		DISCN	Yes	No

Expired US Patents for MPI DMSA KIDNEY REAGENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	MPI DMSA KIDNEY REAGENT	technetium tc-99m succimer kit	INJECTABLE;INJECTION	017944-001	May 18, 1982
Ge Healthcare	MPI DMSA KIDNEY REAGENT	technetium tc-99m succimer kit	INJECTABLE;INJECTION	017944-001	May 18, 1982

International Patents for MPI DMSA KIDNEY REAGENT

See the table below for patents covering MPI DMSA KIDNEY REAGENT around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1029721	TECHNETIUM-LABELED COMPLEXES, PRODUCTION AND USE THEREOF
Sweden	422213	KOMPLEX AV TC-99 M TILL ANVENDNING SOM RADIODIAGNOSTISERINGSMEDEL
Australia	475839
Germany	2617224
France	2229421

Supplementary Protection Certificates for MPI DMSA KIDNEY REAGENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for MPI DMSA Kidney Reagent

Last updated: August 4, 2025

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Introduction

The MPI DMSA Kidney Reagent, a diagnostic radiopharmaceutical used predominantly for renal imaging, has established a crucial role in nephrology and nuclear medicine. Its key application, in identifying renal cortical scarring, differential renal function, and congenital anomalies, positions it as a vital tool for clinicians worldwide. This analysis explores the current market landscape, growth drivers, revenue potential, and future trajectory for the MPI DMSA Kidney Reagent within the broader nuclear medicine segment.

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Market Landscape Overview

The global nuclear medicine market was valued at approximately USD 7.5 billion in 2022, with a compound annual growth rate (CAGR) projected at 4-5% through 2030 [1]. The segment dedicated to renal imaging is sizable within this context, given the increasing prevalence of chronic kidney disease (CKD), renal cancers, and congenital anomalies among aging populations globally.

MPI DMSA, as a specialized agent, comprises a niche but expanding market. Its preference hinges on diagnostic accuracy, safety profile, and regulatory approvals across regions. Currently, North America and Europe represent mature markets, with Asia-Pacific emerging rapidly due to increasing healthcare infrastructure and rising CKD cases.

Market Drivers

1. Growing Burden of Renal Diseases

   CKD affects an estimated 10% of the global population, with rising incidence driven by diabetes, hypertension, and aging demographics [2]. Accurate imaging, such as MPI DMSA scans, is essential for early detection, influencing demand.

2. Technological Advancements

   Innovations in imaging modalities and radiotracer synthesis have enhanced diagnostic precision. The development of hybrid imaging techniques integrating SPECT/CT has improved localization and assessment, backing the relevance of agents like MPI DMSA.

3. Regulatory Approvals and Healthcare Policy

   Optimized regulatory pathways in the U.S. (FDA) and Europe (EMA) facilitate market access. Pending or granted approvals for new formulations or improved versions could catalyze sales.

4. Increasing Adoption in Pediatric and Congenital Renal Malgraphy

   MPI DMSA's safety and effectiveness in children promote its use over traditional contrast-based methods, especially as concerns over nephrotoxicity grow.

5. Expansion into Emerging Markets

   Asia-Pacific and Latin America are witnessing increased adoption driven by rising healthcare investments, improving diagnostic workflows, and unmet needs in renal imaging.

Market Restraints and Challenges

• Radiation Exposure Concerns

  While MPI DMSA is effective, its radiation dose may limit repeated imaging, especially in pediatric populations.

• Availability of Alternative Modalities

  The advent of MRI and ultrasonography, which pose no radiation risk, is positioning as alternative options in renal imaging, although they lack the specificity of radiotracers.

• Regulatory Hurdles

  Limited approvals for new indications or formulations constrain market growth in some geographies.

• Limited Reimbursement

  Variability in reimbursement policies for nuclear imaging procedures affects market penetration.

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Financial Trajectory and Revenue Outlook

Market Size and Revenue Potential

Currently, the MPI DMSA market is valued in the hundreds of millions USD globally. The compound annual growth rate (CAGR) of this segment may mirror the broader nuclear medicine market—approximately 4-5%—driven by increasing clinical adoption and expanding indications.

Pricing Dynamics

Pricing varies significantly based on regional policies, healthcare reimbursement, and manufacturing costs. In mature markets like the U.S., procedure costs range from USD 1,200 to USD 2,500 per scan. The reagent’s cost constitutes a fraction of this but remains pivotal for suppliers.

Manufacturing and Supply Chain Considerations

MPI DMSA relies on technetium-99m, which is produced in a limited number of reactors globally, creating supply constraints. This dependence impacts pricing stability and availability, influencing revenue trajectories.

Potential for Market Expansion

Emerging trends, such as the use of MPI DMSA in adult renal tumor staging or transplantation assessments, could unlock additional revenue streams. Also, partnerships with radiopharmaceutical producers and governments to streamline production may enhance access and volumes.

Regulatory Environment and Competitive Landscape

Actors like Mallinckrodt and Curium are major suppliers of radiopharmaceuticals, including DMSA formulations. Regulatory approvals for new indications and streamlined licensing protocols will significantly influence market expansion.

Emerging competitors leveraging novel radiotracers or alternative imaging modalities pose competitive pressure. However, MPI DMSA's established diagnostic specificity sustains its relevance.

Future Market Trajectory

Based on current trends, the MPI DMSA Kidney Reagent market is poised for modest but steady growth over the next decade. Key factors influencing this trajectory include:

• Increased clinical adoption driven by rising renal disease prevalence.

• Regulatory approvals expanding indications, especially in pediatric care and congenital anomaly detection.

• Advances in hybrid imaging techniques enhancing diagnostic utility.

• Supply chain innovations potentially stabilizing radiotracer availability.

• Pricing strategies balancing cost recovery and market competitiveness.

Overall, a CAGR of approximately 4-5% seems plausible, with revenue potentially surpassing USD 500 million globally by 2030.

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Key Opportunities and Strategic Recommendations

• Invest in R&D to develop longer-lived or more stable DMSA derivatives, improving shelf life and accessibility.

• Expand regulatory approvals in emerging markets with rising renal pathology incidence.

• Leverage technological integration with hybrid imaging platforms to enhance diagnostic accuracy and clinician uptake.

• Optimize supply chains by fostering partnerships with reactor operators to ensure stable technetium-99m supply.

• Promote clinical trials validating new indications and comparative studies against emerging alternatives.

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Conclusion

The MPI DMSA Kidney Reagent occupies a critical niche in renal nuclear imaging, with a stable yet evolving market. Growth will be propelled primarily by increasing renal disease prevalence, technological integration, and expanding clinical applications. Manufacturers and stakeholders should focus on regulatory agility, supply chain robustness, and innovation to capitalize on the market’s full potential.

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Key Takeaways

• The global nuclear medicine market, particularly renal imaging agents like MPI DMSA, is poised for steady growth driven by rising CKD prevalence.

• Supply chain constraints, especially dependent on technetium-99m availability, remain a key factor influencing revenue trajectory.

• Regulatory expansion and technological innovation are critical avenues for market growth and differentiation.

• Emerging markets present significant opportunities for increased adoption, provided reimbursement and infrastructure support.

• Strategic investments in R&D and supply chain stabilization will underpin sustained growth in this niche segment.

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FAQs

1. What are the primary clinical benefits of MPI DMSA in renal imaging?
   MPI DMSA provides high-resolution visualization of renal cortical tissue, allowing accurate detection of scarring, congenital anomalies, and differential renal function with minimal nephrotoxicity.

2. How does supply chain variability of technetium-99m impact the MPI DMSA market?
   Dependence on a limited number of reactors makes the supply vulnerable to disruptions, affecting availability, pricing, and consequently, the revenue and adoption rates of MPI DMSA.

3. Are there significant alternative imaging modalities replacing MPI DMSA?
   While ultrasound and MRI are alternatives with no radiation exposure, they lack the diagnostic specificity and functional assessment capacity offered by MPI DMSA, limiting replacements.

4. What regions represent the fastest-growing markets for MPI DMSA?
   Asia-Pacific and Latin America are anticipated to experience rapid growth owing to increased healthcare investments, rising CKD rates, and expanding diagnostic infrastructure.

5. What future innovations could influence the market trajectory of MPI DMSA?
   Innovations include development of novel radiotracers with longer shelf life, hybrid imaging techniques combining SPECT/CT, and improved manufacturing processes to boost supply stability.

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References

[1] Global Nuclear Medicine Market Report, 2022-2030. Data Bridge Market Research.
[2] Mills, K. T., et al. "Global prevalence of chronic kidney disease – a systematic review and meta-analysis." PLoS ONE, 2015.