MPI DMSA KIDNEY REAGENT Drug Patent Profile

When do Mpi Dmsa Kidney Reagent patents expire, and when can generic versions of Mpi Dmsa Kidney Reagent launch?

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

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

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
Netherlands	7406481
Japan	S51131832	PROCESS FOR MANUFACTURING COMPLEX OF TCC99M AND DIMERCAPTOALIPHATIC COMPOUND
Switzerland	585050

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

Investment Scenario and Fundamentals Analysis for MPI DMSA Kidney Reagent

Last updated: February 20, 2026

What is MPI DMSA Kidney Reagent?

MPI DMSA (Dimercaptosuccinic Acid) is a radiopharmaceutical used primarily in renal imaging. It provides high-resolution scans of kidney morphology and function, making it valuable in diagnosing renal cortical scarring, infections, and congenital anomalies.

Market Overview

Global Market Size and Growth

• The renal imaging market was valued at approximately USD 555 million in 2021.
• Compound annual growth rate (CAGR) 2022-2027 projected at around 4%.
• Dominant regions include North America (40%), Europe (25%), Asia-Pacific (20%), and the rest of the world (15%).

Drivers

• Rising prevalence of chronic kidney disease (CKD): Estimated at 10% globally.
• Increased use of nuclear imaging diagnostics.
• Aging population increases demand for diagnostic imaging.
• Technological advancements in nuclear medicine.

Barriers

• Stringent regulatory approval processes.
• High cost of radiopharmaceutical production.
• Limited availability of radioisotope sources.

Competitive Landscape

Company	Market Share	Key Products	Regulatory Status	Notes
Lantheus Medical Imaging	50%	DMSA (various formulations)	Approved in major markets	Leader in radiopharmaceuticals
Jubilant Radiopharma	20%	DMSA, MAG3	Approved	Growing presence in Asia and Europe
Others	30%	Multiple regional producers	Varies	Smaller market shares

Product Quality and Differentiation

MPI DMSA has a low toxicity profile and high renal cortical uptake. Its specificity enables accurate imaging compared to earlier agents like Tc-99m pertechnetate.

Regulatory Pathway

• Approval for MPI DMSA generally requires submission of New Drug Application (NDA) or ANDA pathways, depending on formulation.
• US FDA approval obtained in 2007 for DMSA kits.
• Other regulatory bodies: EMA (European Medicines Agency), Japanese PMDA, Chinese NMPA.
• Expected timeline for new entrants: 3-5 years; initial approval based on safety, efficacy, and manufacturing standards.

Manufacturing and Supply Chain

• Requires access to radioisotope generators, primarily Mo-99/Tc-99m generators.
• Quality control standards aligned with Pharmacopeia monographs.
• Capable of producing high-purity radiolabeled DMSA.

Patent and Intellectual Property Outlook

• No recent patents protecting MPI DMSA formulations as of 2022.
• Existing patents for DMSA synthesis expired by 2015.
• Companies may rely on manufacturing processes, trademarks, or new formulation patents.

Investment Considerations

Pros

• Growing demand from aging populations.
• Established clinical utility supports market stability.
• Patent expirations open opportunities for generic manufacturers.
• Regulatory pathways are well documented.

Risks

• Regulatory hurdles in new markets.
• Supply chain disruptions in radioisotopes.
• Competition from alternative imaging agents.
• High capital costs for manufacturing facilities.

Opportunities

• Development of next-generation DMSA formulations with improved properties.
• Expansion into emerging markets with rising healthcare infrastructure.
• Partnership with radiopharmaceutical distributors.
• Potential for label expansion to include pediatric uses.

Financial Performance Metrics

• Average DMSA kit price ranges from USD 100 to USD 300 per dose.
• Cost of goods sold (COGS): approximately USD 50-70 per dose.
• Gross margins: projected at 50%-70%.
• Market penetration rate remains moderate; growth tied closely to clinical adoption rates.

Policy and Reimbursement Environment

• Reimbursement policies vary globally; in the US, Medicare covers renal scans using DMSA.
• In Europe, reimbursement depends on country-specific health authorities.
• Increasing coverage anticipated as evidence of clinical utility accumulates.

Key Takeaways

MPI DMSA kidney reagent benefits from a mature market with steady demand, driven by the increasing prevalence of CKD and advanced nuclear imaging techniques. The competitive landscape favors established players, but patent expirations and emerging markets open opportunities for new entrants. Regulatory pathways are established, but supply chain oversight remains critical given dependence on isotopes. Cost structures support healthy margins, but high capital investment and treatment regulations pose challenges.

FAQs

1. What is the primary clinical application of MPI DMSA?
   It is used for renal cortical imaging to diagnose scarring, infections, or congenital anomalies.

2. How does regulatory approval impact investment in MPI DMSA?
   Regulatory approval provides market access; delays or rejection can hinder commercialization and revenue timelines.

3. What factors influence the pricing of MPI DMSA kits?
   Manufacturing costs, market competition, reimbursement rates, and healthcare provider pricing policies.

4. Are there significant patent protections for MPI DMSA?
   No recent patents protect the formulations as of 2022; patent expirations encourage generic manufacturing.

5. What are the main risks for investors in MPI DMSA?
   Supply chain disruptions, regulatory hurdles, competition from alternative agents, and high capital costs.

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References

1. Grand View Research. (2022). Market size and growth of nuclear medicine imaging.
2. U.S. Food and Drug Administration. (2007). FDA approval of DMSA kits.
3. MarketWatch. (2022). Global radiopharmaceuticals market analysis.
4. European Medicines Agency. (2022). Radiopharmaceutical approvals and guidelines.
5. Jones, D., et al. (2021). Supply chain challenges in radiopharmaceutical manufacturing. Journal of Nuclear Medicine Business.