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Last Updated: December 22, 2024

Technetium tc-99m sulfur colloid kit - Generic Drug Details


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What are the generic sources for technetium tc-99m sulfur colloid kit and what is the scope of patent protection?

Technetium tc-99m sulfur colloid kit is the generic ingredient in five branded drugs marketed by Sun Pharm Inds Inc, Mallinckrodt, Ge Healthcare, Jubilant, and Bracco, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for technetium tc-99m sulfur colloid kit
Recent Clinical Trials for technetium tc-99m sulfur colloid kit

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OnLume Inc.Early Phase 1
National Cancer Institute (NCI)Early Phase 1
University of Wisconsin, MadisonEarly Phase 1

See all technetium tc-99m sulfur colloid kit clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for technetium tc-99m sulfur colloid kit

US Patents and Regulatory Information for technetium tc-99m sulfur colloid kit

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant TECHNETIUM TC-99M SULFUR COLLOID KIT technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 213516-001 Nov 9, 2023 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bracco TESULOID technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 016923-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc AN-SULFUR COLLOID technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017858-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ge Healthcare TECHNETIUM TC 99M TSC technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017784-001 Approved Prior to Jan 1, 1982 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

Technetium tc-99m sulfur colloid kit Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Technetium Tc-99m Sulfur Colloid Kit

Introduction

Technetium Tc-99m Sulfur Colloid Kit is a radiopharmaceutical agent widely used in medical imaging, particularly for diagnosing and monitoring various conditions involving the reticuloendothelial system. This article delves into the market dynamics and financial trajectory of this critical diagnostic tool.

Market Overview

The market for Technetium Tc-99m Sulfur Colloid Kit is part of the broader radiopharmaceuticals market, which has been growing steadily due to increasing demand for diagnostic imaging in healthcare.

Key Players

Major companies involved in the production and distribution of Technetium Tc-99m Sulfur Colloid Kits include GE Healthcare Canada Inc., CIS-US, Inc., and Medi-Physics, Inc.[2][3][4].

Product Indications

Technetium Tc-99m Sulfur Colloid Injection is used in adults and children for imaging areas of functioning reticuloendothelial cells in the liver, spleen, and bone marrow. It is also used orally for esophageal transit studies and gastroesophageal reflux studies[2].

Market Drivers

Several factors drive the demand for Technetium Tc-99m Sulfur Colloid Kits:

Increasing Prevalence of Diseases

The rising incidence of diseases such as liver and spleen disorders, as well as the need for accurate diagnostic tools in oncology, particularly for sentinel lymph node biopsies, drives the demand for this radiopharmaceutical[5].

Technological Advancements

Improvements in preparation methods, such as reduced heating protocols and the use of new 99mTc-elution techniques, have enhanced the stability and efficacy of the product, making it more appealing to healthcare providers[4].

Regulatory Approvals

Regulatory approvals and compliance with pharmacopeial standards, such as those set by the United States Pharmacopeia, ensure the product's safety and efficacy, which in turn boosts market confidence[2].

Market Challenges

Despite the growth drivers, the market faces several challenges:

Supply Chain Issues

The production of Technetium Tc-99m is heavily dependent on the availability of Molybdenum-99, which can be subject to supply chain disruptions. This can impact the consistent availability of the final product[2].

Competition from Alternatives

The introduction of alternative radiopharmaceuticals, such as Technetium Tc-99m albumin colloid, can pose competition to Technetium Tc-99m Sulfur Colloid Kits[5].

Regulatory Hurdles

Changes in regulatory requirements and the need for continuous compliance can be a challenge for manufacturers, potentially affecting production costs and timelines[3].

Financial Trajectory

The financial performance of the Technetium Tc-99m Sulfur Colloid Kit market is influenced by several factors:

Revenue Growth

The market has seen steady revenue growth due to the increasing demand for diagnostic imaging. The precise revenue figures are not publicly disclosed, but the overall radiopharmaceuticals market is projected to grow significantly over the coming years.

Cost Structure

The cost of producing Technetium Tc-99m Sulfur Colloid Kits includes the cost of raw materials (Molybdenum-99), manufacturing processes, and regulatory compliance. These costs can fluctuate based on supply chain stability and regulatory changes[2].

Pricing Strategies

Manufacturers often employ competitive pricing strategies to maintain market share. The pricing is also influenced by the cost of alternative diagnostic tools and the overall healthcare budget allocations[3].

Market Segmentation

The market can be segmented based on several criteria:

By Application

  • Liver and spleen imaging
  • Bone marrow imaging
  • Sentinel lymph node biopsies
  • Esophageal transit and gastroesophageal reflux studies[2][5].

By Geography

The market is segmented geographically, with different regions having varying demand based on healthcare infrastructure and disease prevalence.

By End User

The primary end users are hospitals, diagnostic imaging centers, and research institutions.

Competitive Landscape

The competitive landscape is characterized by a few key players:

GE Healthcare Canada Inc.

GE Healthcare is a significant player in the radiopharmaceuticals market, offering a range of diagnostic imaging solutions, including the Technetium Tc-99m Sulfur Colloid Kit[2].

CIS-US, Inc.

CIS-US, Inc. is another major player, particularly known for its AN-SULFUR COLLOID® kit, which is widely used in the United States market[1].

Medi-Physics, Inc.

Although Medi-Physics, Inc. has discontinued some of its kits, it remains a notable player in the industry, with a history of contributing to the development of radiopharmaceuticals[1].

Future Outlook

The future outlook for the Technetium Tc-99m Sulfur Colloid Kit market is promising:

Growing Demand for Diagnostic Imaging

The increasing need for accurate and efficient diagnostic tools in healthcare will continue to drive the demand for this product.

Technological Innovations

Advancements in preparation methods and imaging technologies will enhance the product's efficacy and stability, further solidifying its position in the market[4].

Expanding Applications

The potential for expanded applications, such as in oncology and gastroenterology, offers additional growth opportunities.

Key Takeaways

  • Increasing Demand: The market is driven by the growing need for diagnostic imaging in various medical conditions.
  • Technological Advancements: Improvements in preparation methods have enhanced the product's stability and efficacy.
  • Regulatory Compliance: Adherence to pharmacopeial standards is crucial for market confidence.
  • Supply Chain Challenges: The availability of Molybdenum-99 can impact production.
  • Competitive Landscape: A few key players dominate the market, with GE Healthcare and CIS-US, Inc. being prominent.

FAQs

What is Technetium Tc-99m Sulfur Colloid Kit used for?

Technetium Tc-99m Sulfur Colloid Kit is used for imaging areas of functioning reticuloendothelial cells in the liver, spleen, and bone marrow, as well as for esophageal transit and gastroesophageal reflux studies.

Who are the major players in the Technetium Tc-99m Sulfur Colloid Kit market?

Major players include GE Healthcare Canada Inc., CIS-US, Inc., and Medi-Physics, Inc.

What are the key drivers of the Technetium Tc-99m Sulfur Colloid Kit market?

Key drivers include the increasing prevalence of diseases, technological advancements, and regulatory approvals.

What challenges does the Technetium Tc-99m Sulfur Colloid Kit market face?

The market faces challenges such as supply chain issues, competition from alternative radiopharmaceuticals, and regulatory hurdles.

What is the future outlook for the Technetium Tc-99m Sulfur Colloid Kit market?

The future outlook is promising, driven by growing demand for diagnostic imaging, technological innovations, and expanding applications.

Sources

  1. Filtered Technetium-99m-Sulfur Colloid Evaluated for Lymphoscintigraphy - Journal of Nuclear Medicine[1].
  2. Technetium Tc 99m TSC Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection - GE Healthcare Canada Inc.[2].
  3. Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection - FDA Approval Letter[3].
  4. Technetium-99m-sulfur colloid for lymphoscintigraphy - PubMed[4].
  5. Technetium-99m sulfur colloid: Topics by Science.gov - Science.gov[5].

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