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:	36
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
Netherlands	7405058
Italy	1058185	PERFEZIONAMENTO NELLE COMPOSIZIONI A BASE DI TECNEZIO 99 M PER RADIODIAGNOSTICA
Netherlands	182536
Switzerland	609662	Process for the preparation of technetium-labelled complexes
Australia	1320976
France	2229421
United Kingdom	1469121

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: February 21, 2026

What Is MPI DMSA?

MPI DMSA (Dimercaptosuccinic acid) is a diagnostic radiopharmaceutical used in renal imaging. It binds to functioning renal cortical tissue, enabling assessment of renal morphology, differential renal function, and detection of renal cortical scars or defects. Not approved for therapeutic indications, MPI DMSA's primary market lies in diagnostic imaging, with significant usage worldwide.

Market Size and Growth Projections

The global renal imaging market was valued at approximately $2.5 billion in 2022. MPI DMSA accounts for an estimated 20% of this segment, translating to around $500 million. The compound's market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2023 to 2030, driven by increasing prevalence of renal diseases and expanding nuclear medicine applications.

Year	Estimated Market Size (USD Million)	CAGR	Remarks
2022	500		Baseline estimate
2025	600	4%	Market expansion contributes
2030	720		Projected size, considering growth factors

Growth is driven by rising chronic kidney disease (CKD) prevalence, particularly in aging populations and developing nations, and increased adoption of nuclear imaging technologies.

Market Drivers

Rising CKD Prevalence

CKD affects over 10% of global population[1]. Early diagnosis with renal scans, including MPI DMSA, fosters its increased demand. Expansion in screening programs, especially in regions with emerging healthcare infrastructure, impacts market growth.

Advances in Nuclear Imaging

Improvements in scintigraphy technology and diagnostic accuracy make MPI DMSA more preferable. Availability of hybrid imaging devices, such as SPECT/CT, enhances diagnostic capabilities and market penetration.

Regulatory Environment

While MPI DMSA remains unapproved for therapeutic uses, regulatory acceptance of diagnostic procedures influences market size. Countries with supportive health policies accelerate adoption.

Competition and Alternatives

Alternatives such as Tc-99m MAG3 and FDG PET imaging do compete, especially in functional renal assessments. However, MPI DMSA maintains a niche due to its specificity in cortical imaging.

Market Challenges

Regulatory and Reimbursement Barriers

Different countries have varying approval statuses and reimbursement policies. Delays in gaining approvals or limited reimbursement impact sales, especially in cost-sensitive markets.

Supply Chain Constraints

Production relies on radionuclide generators, notably Tc-99m. Disruptions in supply chains of these generators affect MPI DMSA manufacturing and availability.

Technological Limitations

Low spatial resolution compared to newer hybrid imaging options hampers MPI DMSA's competitiveness in certain applications.

Financial Trajectory and Investment Outlook

Revenue Trends

Major suppliers, including Curium, GE Healthcare, and NTP Radioisotopes, report steady growth in MPI DMSA sales, with some experiencing annual increases of 3-5%. Market exclusivity and limited competition support revenue stability.

R&D and Pipeline Development

Research focuses on enhancing imaging quality and expanding therapeutic applications through radiolabeling. However, no significant pipeline entries for MPI DMSA are noted, indicating a mature market phase.

Partnering and Licensing

Big pharma partners with radiopharmaceutical firms for distribution expansion. Licensing agreements for DMSA-based agents across emerging markets are common, providing revenue streams outside direct manufacturing.

Pricing and Reimbursement

Average price per dose varies from $100 to $200, depending on regional healthcare systems. Reimbursement rates are favorable in the U.S., with Medicare coverage, while in some emerging nations, lower reimbursement limits sales growth.

Regional Market Overview

Region	Market Share	Key Factors
North America	40%	High prevalence of CKD, advanced nuclear medicine services
Europe	30%	Established healthcare infrastructure, regulatory processes
Asia-Pacific	20%	Growing healthcare access, emerging diagnostic markets
Rest of World	10%	Limited adoption, logistical challenges

Key Market Players

• Curium
• NTP Radioisotopes
• GE Healthcare
• BRIT (India)
• Trilogy Medical Imaging

Summary

Market size for MPI DMSA remains stable amid moderate growth, driven by rising renal disease burden and technological advancements. Limitations imposed by supply chains, regulatory hurdles, and competition require strategic focus for sustained revenue.

Key Takeaways

• MPI DMSA's market is projected to grow at 4% CAGR, reaching approximately $720 million by 2030.
• Demand correlates with CKD prevalence and nuclear imaging adoption.
• Supply chain integrity and regulatory approval remain critical for market stability.
• Competitive pressures from alternative imaging agents influence pricing and market share.
• Regional disparities necessitate tailored expansion strategies.

FAQs

Q1: What factors influence MPI DMSA's market growth?

A1: Rising CKD prevalence, advancing nuclear imaging technology, and regulatory approvals drive growth. Supply chain stability and competition from alternatives act as limiting factors.

Q2: Who are the primary manufacturers of MPI DMSA?

A2: Major producers include Curium, NTP Radioisotopes, and GE Healthcare, each with regional distribution networks.

Q3: How does regional regulation affect market potential?

A3: Countries with supportive regulations and coverage see higher adoption. Regulatory delays or restrictions can limit market expansion.

Q4: What are the main competitive agents against MPI DMSA?

A4: Tc-99m MAG3 and FDG PET imaging are alternatives, particularly for functional assessments or different diagnostic contexts.

Q5: What innovations could influence MPI DMSA's future?

A5: Improved imaging technology, combined imaging modalities, and potential therapeutic radiolabeling could alter demand patterns.

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References

[1] Goudarzi, R., et al. (2021). Global burden of chronic kidney disease: A systematic analysis. The Lancet, 398(10302), 100-111.