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:	7
Patent Applications:	95
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	4,208,398
Ge Healthcare	MPI DMSA KIDNEY REAGENT	technetium tc-99m succimer kit	INJECTABLE;INJECTION	017944-001	May 18, 1982	4,233,285

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
United Kingdom	1489531
United Kingdom	1469122
Australia	6815174
Netherlands	7405058

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

MPI DMSA KIDNEY REAGENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MPI DMSA Kidney Reagent

Introduction

The MPI DMSA Kidney Reagent, utilizing Technetium-99m dimercaptosuccinic acid (DMSA), is a crucial diagnostic tool in nuclear medicine for evaluating renal parenchyma disorders. This article delves into the market dynamics and financial trajectory of this reagent, highlighting its clinical significance, market trends, and financial implications.

Clinical Significance of DMSA Scans

DMSA scans are essential for assessing kidney function and structure. They provide a clearer picture of the kidneys compared to standard imaging tests, making them invaluable in diagnosing and managing kidney disorders such as pyelonephritis, renal scarring, and congenital anomalies[5].

Market Demand and Growth

The demand for DMSA scans is driven by the increasing prevalence of kidney diseases and the need for accurate diagnostic tools. Here are some key factors influencing market demand:

Prevalence of Kidney Diseases

The rising incidence of chronic kidney disease (CKD) and acute kidney injury (AKI) globally contributes to the growing demand for diagnostic tests like DMSA scans. According to various studies, the prevalence of CKD is increasing, which necessitates more frequent use of diagnostic tools to monitor and manage the condition[5].

Technological Advancements

Advancements in nuclear medicine, such as the use of Single Photon Emission Computed Tomography (SPECT), have enhanced the accuracy and reliability of DMSA scans. This has led to increased adoption of these scans in clinical practice[3].

Regulatory Approvals and Guidelines

Regulatory approvals and clinical guidelines that recommend the use of DMSA scans for specific indications also drive market demand. For instance, DMSA scans are recommended for evaluating compensatory changes after nephrectomy and for assessing renal function in patients with various kidney disorders[2].

Market Competition

The market for renal scintigraphy agents is competitive, with several radiopharmaceuticals available, including Technetium-99m DTPA and Technetium-99m MAG3.

Comparative Analysis

Studies have shown a high correlation between DMSA scans and dynamic scintigraphies like DTPA and MAG3 in evaluating relative renal function. However, DMSA scans have a unique advantage in providing static images of the renal cortex, which is particularly useful in certain clinical scenarios[4].

Financial Trajectory

The financial performance of the MPI DMSA Kidney Reagent is influenced by several factors:

Revenue Streams

Revenue is generated through the sale of the reagent kits to hospitals, diagnostic centers, and research institutions. The cost of each kit, which includes the radiopharmaceutical and necessary reagents, contributes to the overall revenue.

Pricing and Cost Analysis

The pricing of DMSA reagent kits can vary based on geographical location, market competition, and regulatory factors. The cost-effectiveness of DMSA scans compared to other diagnostic methods also plays a role in determining pricing strategies.

Market Size and Growth Projections

The global market for renal scintigraphy agents is expected to grow due to the increasing demand for accurate diagnostic tools. Market research indicates that the nuclear medicine market, which includes DMSA scans, is projected to grow significantly over the next few years.

Challenges and Opportunities

Radiation Safety and Regulatory Compliance

One of the significant challenges is ensuring compliance with radiation safety guidelines to minimize exposure to patients and healthcare workers. This requires continuous investment in safety protocols and training for healthcare professionals[1].

Research and Development

Opportunities exist in further research and development to enhance the efficacy and safety of DMSA scans. For example, studies on the use of DMSA scans in predicting postoperative renal function after nephrectomy have shown promising results[2].

Key Players and Market Share

The market for DMSA reagents is dominated by a few key players, including pharmaceutical companies and specialized radiopharmaceutical manufacturers. Market share is influenced by factors such as product quality, distribution networks, and marketing strategies.

Regional Market Analysis

The demand for DMSA scans varies by region, influenced by factors such as healthcare infrastructure, prevalence of kidney diseases, and regulatory environments.

Developed Markets

In developed countries, there is a higher adoption rate of advanced diagnostic tools like DMSA scans due to better healthcare infrastructure and higher awareness among healthcare professionals.

Emerging Markets

In emerging markets, the growth potential is significant due to increasing healthcare spending and a rising awareness of the importance of early diagnosis and management of kidney diseases.

Conclusion

The MPI DMSA Kidney Reagent is a vital tool in the diagnosis and management of kidney disorders. The market dynamics are driven by the increasing prevalence of kidney diseases, technological advancements, and regulatory approvals. While there are challenges related to radiation safety and regulatory compliance, opportunities exist in research and development to further enhance the efficacy and safety of DMSA scans.

Key Takeaways

• Increasing Demand: The demand for DMSA scans is driven by the rising prevalence of kidney diseases.
• Technological Advancements: SPECT technology has improved the accuracy and reliability of DMSA scans.
• Market Competition: DMSA scans compete with other radiopharmaceuticals like DTPA and MAG3 but offer unique advantages.
• Financial Growth: The market for renal scintigraphy agents, including DMSA, is expected to grow significantly.
• Challenges and Opportunities: Ensuring radiation safety and investing in R&D are crucial for market growth.

FAQs

Q: What is the primary use of the MPI DMSA Kidney Reagent? A: The MPI DMSA Kidney Reagent is used as an aid in the scintigraphic evaluation of renal parenchyma disorders.

Q: How does DMSA scan compare to other renal scintigraphy methods? A: DMSA scans have a high correlation with dynamic scintigraphies like DTPA and MAG3 but provide unique static images of the renal cortex.

Q: What are the potential risks associated with DMSA scans? A: Rare instances of syncope, fever, nausea, and maculopapular skin rash have been reported. Additionally, there are concerns about radiation exposure[1].

Q: Can DMSA scans be used in pediatric patients? A: The safety and effectiveness of DMSA scans in children have not been established, and their use should be carefully considered[1].

Q: How do market trends influence the financial trajectory of the MPI DMSA Kidney Reagent? A: Market trends such as the increasing prevalence of kidney diseases, technological advancements, and regulatory approvals drive the financial growth of the MPI DMSA Kidney Reagent.

Sources

1. Technetium Te99m Succimer Kit: INDICATIONS AND USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS.
2. The value of quantitative 99M technetium dimercaptosuccinic acid: Before surgery DMSA scan of the remaining kidney.
3. Quantitation of renal uptake of technetium-99m DMSA using SPECT: Quantitative single photon emission computed tomography (SPECT) methodology.
4. Comparison of 99mTc-DMSA, 99mTc-DTPA and 99mTc-MAG3 renal scintigraphy: High correlation between DMSA and dynamic scintigraphies.
5. DMSA Renal Scan: DMSA renal kidney scan is a kidney imaging test that gives a clearer picture of the kidneys.