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Last Updated: December 23, 2024

MANGAFODIPIR TRISODIUM - Generic Drug Details


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What are the generic drug sources for mangafodipir trisodium and what is the scope of freedom to operate?

Mangafodipir trisodium is the generic ingredient in one branded drug marketed by Ic Targets and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for MANGAFODIPIR TRISODIUM
Recent Clinical Trials for MANGAFODIPIR TRISODIUM

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SponsorPhase
National Institute of Neurological Disorders and Stroke (NINDS)Phase 1

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Anatomical Therapeutic Chemical (ATC) Classes for MANGAFODIPIR TRISODIUM

US Patents and Regulatory Information for MANGAFODIPIR TRISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ic Targets TESLASCAN mangafodipir trisodium INJECTABLE;INJECTION 020652-001 Nov 26, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MANGAFODIPIR TRISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ic Targets TESLASCAN mangafodipir trisodium INJECTABLE;INJECTION 020652-001 Nov 26, 1997 4,647,447 ⤷  Subscribe
Ic Targets TESLASCAN mangafodipir trisodium INJECTABLE;INJECTION 020652-001 Nov 26, 1997 5,223,243 ⤷  Subscribe
Ic Targets TESLASCAN mangafodipir trisodium INJECTABLE;INJECTION 020652-001 Nov 26, 1997 5,091,169 ⤷  Subscribe
Ic Targets TESLASCAN mangafodipir trisodium INJECTABLE;INJECTION 020652-001 Nov 26, 1997 4,933,456 ⤷  Subscribe
Ic Targets TESLASCAN mangafodipir trisodium INJECTABLE;INJECTION 020652-001 Nov 26, 1997 4,992,554 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

MANGAFODIPIR TRISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Mangafodipir Trisodium

Introduction

Mangafodipir trisodium, marketed under the brand name Teslascan, is a contrast agent used in magnetic resonance imaging (MRI) to enhance the visualization of liver and pancreatic tissues. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its historical performance, current status, and potential future directions.

Historical Market Presence

Mangafodipir trisodium was first introduced to the market as a diagnostic tool for MRI imaging. It was approved by the FDA and initially gained traction for its ability to enhance contrast in liver and pancreatic imaging, particularly for detecting lesions such as liver metastases and hepatocellular carcinomas[2][3][4].

Commercial Withdrawal

Despite its clinical utility, mangafodipir trisodium was withdrawn from the US market in 2003 and the European market in 2012 by its manufacturer for commercial reasons. This decision was not based on safety or efficacy concerns but rather on economic factors, indicating that the drug did not meet the expected market demand or revenue targets[1][2][4].

Safety and Tolerability

Clinical trials and studies have consistently shown that mangafodipir trisodium is well-tolerated in human populations. The most common side effects reported were mild, including facial flushing, headache, and nausea, which were transient and did not pose significant safety concerns[3][4].

Pharmacokinetics and Metabolism

The drug is metabolized and manganese ions are released from the mangafodipir complex, primarily through exchange with plasma zinc. The manganese ions are then taken up by various tissues, including the liver, pancreas, kidneys, and spleen. This pharmacokinetic profile supports its use as an MRI contrast agent but also highlights the complexity of its metabolism and elimination[4].

Therapeutic Potential Beyond Imaging

In addition to its role as an MRI contrast agent, mangafodipir trisodium has been explored for its therapeutic potential. It has shown promise as a chemotherapy adjunct to prevent drug-induced neuropathy and as a cardio-protectant following acute myocardial infarction. The drug's ability to scavenge superoxide anions generated by chemotherapeutics is particularly noteworthy[3].

Current Market Status

Although mangafodipir trisodium is no longer widely used for imaging studies due to its commercial withdrawal, it remains an FDA-approved drug. Ongoing research and clinical trials are investigating its therapeutic applications, which could potentially revive its market presence[3].

Future Prospects

The near future may see a resurgence of mangafodipir trisodium in the market, particularly in the context of translational research and new therapeutic applications. Advances in imaging technologies, such as high-field MRI and combined PET-MRI imaging, could enhance the drug's utility and detection capabilities. Moreover, its potential in treating neurodegenerative diseases and monitoring response to pharmaceutical interventions could open new avenues for its use[3].

Financial Implications

The financial trajectory of mangafodipir trisodium has been marked by initial investment in its development and marketing, followed by a decline due to its commercial withdrawal. However, the ongoing research and potential new applications could lead to renewed investment and revenue streams. The drug's versatility and the expanding understanding of its therapeutic properties make it an attractive candidate for future financial growth.

Key Takeaways

  • Commercial History: Mangafodipir trisodium was withdrawn from major markets due to commercial reasons despite its clinical efficacy.
  • Safety Profile: The drug is well-tolerated with mild side effects.
  • Therapeutic Potential: It has promising applications beyond imaging, including as a chemotherapy adjunct and cardio-protectant.
  • Current Status: Although not widely used for imaging, it remains FDA-approved and is under investigation for new uses.
  • Future Prospects: Advances in imaging and therapeutic research could revive its market presence.

FAQs

What is mangafodipir trisodium used for?

Mangafodipir trisodium is primarily used as an MRI contrast agent to enhance the visualization of liver and pancreatic tissues, particularly for detecting lesions such as liver metastases and hepatocellular carcinomas.

Why was mangafodipir trisodium withdrawn from the market?

It was withdrawn from the US and European markets for commercial reasons, not due to safety or efficacy concerns.

What are the common side effects of mangafodipir trisodium?

The most common side effects are facial flushing, headache, and nausea, which are generally mild and transient.

What are the therapeutic applications of mangafodipir trisodium beyond imaging?

It is being explored as a chemotherapy adjunct to prevent drug-induced neuropathy and as a cardio-protectant following acute myocardial infarction.

What are the future prospects for mangafodipir trisodium?

Advances in imaging technologies and ongoing research into its therapeutic applications could lead to its resurgence in the market, particularly in translational research and new therapeutic areas.

References

  1. Wikipedia: Mangafodipir
  2. DrugBank Online: Mangafodipir trisodium
  3. UK College of Medicine: A new opportunity for MEMRI
  4. EMA: Teslascan - Product Information
  5. ACS Publications: Efficient Removal of Polycyclic Aromatic Hydrocarbons and Heavy Metals Using Poly-CD Nanofibrous Membranes

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