Thallous chloride tl-201 - Generic Drug Details

What are the generic drug sources for thallous chloride tl-201 and what is the scope of freedom to operate?

Thallous chloride tl-201 is the generic ingredient in one branded drug marketed by Bracco, Curium, Ge Healthcare, Lantheus Medcl, and Trace Life, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for thallous chloride tl-201. One supplier is listed for this compound.

Summary for thallous chloride tl-201

US Patents:	0
Tradenames:	1
Applicants:	5
NDAs:	6
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	53
What excipients (inactive ingredients) are in thallous chloride tl-201?	thallous chloride tl-201 excipients list
DailyMed Link:	thallous chloride tl-201 at DailyMed

Pharmacology for thallous chloride tl-201

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for thallous chloride tl-201

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Curium	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INTRAVENOUS	077698-001	Nov 9, 2006		DISCN	No	No
Curium	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	018150-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Ge Healthcare	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	018110-002	Feb 27, 1996		DISCN	Yes	No
Bracco	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	018548-001	Dec 30, 1982		DISCN	No	No
Trace Life	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	075569-001	Nov 21, 2001		DISCN	No	No
Lantheus Medcl	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INTRAVENOUS	017806-002	Oct 9, 1998		DISCN	Yes	No

Thallous chloride tl-201 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Thallous Chloride Tl-201

Introduction

Thallous Chloride Tl-201 is a diagnostic radiopharmaceutical used primarily for myocardial perfusion imaging. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including healthcare providers, investors, and pharmaceutical companies.

Market Overview

Thallous Chloride Tl-201 is classified under the category of imaging agents and radiopharmaceuticals. It is used in the diagnosis and localization of myocardial infarction, ischemia, and other cardiac conditions. The market for diagnostic radiopharmaceuticals is driven by the increasing demand for accurate and early diagnosis of cardiovascular diseases.

Clinical Indications and Usage

Thallous Chloride Tl-201 is indicated for myocardial perfusion imaging, helping to visualize areas of infarction and ischemia. It accumulates in viable myocardium similar to potassium, making it an effective tool for assessing regional perfusion and identifying areas of cardiac damage[2][4][5].

Competitive Landscape

The market for diagnostic radiopharmaceuticals is competitive, with several other agents available for cardiac imaging, such as Technetium-99m (Tc-99m) and other PET tracers. However, Thallous Chloride Tl-201 maintains a niche due to its specific properties and clinical indications.

Regulatory Environment

Thallous Chloride Tl-201 is regulated by health authorities such as the FDA, which oversees its production, labeling, and usage. Compliance with regulatory requirements is critical for its continued market presence. The FDA provides detailed guidelines on its handling, storage, and administration to ensure patient safety[2][5].

Production and Supply Chain

Thallous Chloride Tl-201 is cyclotron-produced with no carrier added, ensuring high radionuclidic purity. It is supplied in isotonic solution and must be handled with appropriate safety measures due to its radioactive nature. The supply chain involves specialized manufacturers and distributors who ensure the product is delivered in a safe and calibrated state[1][4][5].

Financial Performance

The financial performance of Thallous Chloride Tl-201 is influenced by several factors, including the volume of sales, pricing, and reimbursement policies. Here are some key financial aspects:

Revenue Streams

Revenue is generated through the sale of Thallous Chloride Tl-201 to hospitals, imaging centers, and other healthcare facilities. The pricing is typically based on the activity of the radionuclide and the volume required for each procedure.

Cost Structure

The cost structure includes the production costs of the radionuclide, manufacturing overheads, regulatory compliance expenses, and distribution costs. Given its radioactive nature, handling and storage costs are also significant.

Reimbursement and Insurance

Reimbursement policies play a crucial role in the financial trajectory of Thallous Chloride Tl-201. In many countries, diagnostic procedures using this radiopharmaceutical are covered by health insurance, which helps in maintaining a stable revenue stream.

Market Trends and Growth Prospects

Several trends influence the market dynamics of Thallous Chloride Tl-201:

Increasing Demand for Diagnostic Imaging

The growing prevalence of cardiovascular diseases and the need for early and accurate diagnosis drive the demand for diagnostic imaging agents like Thallous Chloride Tl-201.

Advancements in Imaging Technologies

Advancements in imaging technologies, such as SPECT and PET, enhance the utility and accuracy of Thallous Chloride Tl-201, potentially increasing its market share.

Regulatory and Safety Considerations

Stringent regulatory requirements and safety protocols can impact the production and distribution costs, but they also ensure a high level of patient safety, which is crucial for market acceptance.

Challenges and Limitations

Despite its clinical utility, Thallous Chloride Tl-201 faces several challenges:

Radiation Safety Concerns

The radioactive nature of Thallous Chloride Tl-201 necessitates strict handling and safety protocols, which can be a barrier to widespread adoption[2][5].

Alternative Diagnostic Agents

The availability of alternative diagnostic agents, such as Tc-99m, can compete with Thallous Chloride Tl-201 for market share.

Regulatory and Compliance Issues

Compliance with evolving regulatory standards can be costly and time-consuming, affecting the financial performance of the product.

Key Takeaways

• Clinical Utility: Thallous Chloride Tl-201 is a valuable diagnostic tool for myocardial perfusion imaging.
• Market Dynamics: The market is driven by the demand for accurate cardiac diagnostics and influenced by regulatory, safety, and competitive factors.
• Financial Performance: Revenue is generated through sales to healthcare facilities, with costs including production, regulatory compliance, and distribution.
• Growth Prospects: Increasing demand for diagnostic imaging and advancements in imaging technologies are positive trends, while regulatory and safety concerns pose challenges.

Frequently Asked Questions (FAQs)

Q1: What is the primary use of Thallous Chloride Tl-201? A1: Thallous Chloride Tl-201 is primarily used for myocardial perfusion imaging to diagnose and localize myocardial infarction and ischemia.

Q2: How is Thallous Chloride Tl-201 produced? A2: Thallous Chloride Tl-201 is cyclotron-produced with no carrier added, ensuring high radionuclidic purity.

Q3: What are the key safety considerations for Thallous Chloride Tl-201? A3: Due to its radioactive nature, Thallous Chloride Tl-201 must be handled with appropriate safety measures to minimize radiation exposure.

Q4: How does Thallous Chloride Tl-201 accumulate in the body? A4: Thallous Chloride Tl-201 accumulates in viable myocardium in a manner analogous to potassium, correlating well with regional perfusion.

Q5: Is Thallous Chloride Tl-201 safe for use in pregnant women? A5: Thallous Chloride Tl-201 should not be used in pregnant women except when benefits clearly outweigh the potential risks, and ideally, examinations should be performed during the first few days following the onset of menses[5].

Sources:

1. FDA Label: Thallous Chloride Tl 201 Injection - August 2011
2. FDA Label: Thallous Chloride Tl 201 Injection, Diagnostic—For Intravenous Use - 2016
3. VA Formulary Advisor: THALLOUS CHLORIDE, TL-201 INJ, SOLN
4. Lantheus: Thallium-201
5. Journal of Nuclear Medicine: Medi-Physics' Thallous Chloride TI 201