PENTETATE ZINC TRISODIUM - Generic Drug Details

What are the generic sources for pentetate zinc trisodium and what is the scope of patent protection?

Pentetate zinc trisodium is the generic ingredient in one branded drug marketed by Hameln Pharma Plus and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for PENTETATE ZINC TRISODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	1
Patent Applications:	65
What excipients (inactive ingredients) are in PENTETATE ZINC TRISODIUM?	PENTETATE ZINC TRISODIUM excipients list
DailyMed Link:	PENTETATE ZINC TRISODIUM at DailyMed

Recent Clinical Trials for PENTETATE ZINC TRISODIUM

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2

See all PENTETATE ZINC TRISODIUM clinical trials

Pharmacology for PENTETATE ZINC TRISODIUM

Drug Class	Lead Chelator
Mechanism of Action	Lead Chelating Activity

US Patents and Regulatory Information for PENTETATE ZINC TRISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hameln Pharma Plus	PENTETATE ZINC TRISODIUM	pentetate zinc trisodium	SOLUTION;INHALATION, INTRAVENOUS	021751-001	Aug 11, 2004		DISCN	Yes	No

PENTETATE ZINC TRISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pentetate Zinc Trisodium

Introduction

Pentetate zinc trisodium (Zn-DTPA) is a radiomitigation chelator approved by the FDA for the treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium. This article delves into the market dynamics and financial trajectory of this critical drug.

FDA Approval and Indications

Pentetate zinc trisodium was approved by the FDA in 2004 for its specific indication in treating internal contamination with radioactive materials. The approval was based on its efficacy in increasing the rates of elimination of these radioactive substances from the body[3][4].

Market Niche

Zn-DTPA operates in a specialized market niche, focusing on radiological emergencies and nuclear accidents. This niche market is characterized by a limited but critical demand, primarily driven by government and healthcare institutions prepared for radiological emergencies.

Pricing and Cost Considerations

Given its specialized use and limited market, the pricing of Zn-DTPA is not subject to the same competitive pressures as more widely used drugs. The cost is often covered by government agencies or healthcare institutions, which can mitigate the financial burden on individual patients. However, the exact pricing can vary based on the supplier, distribution channels, and the specific needs of the treatment protocol[3].

Supply and Distribution

The supply chain for Zn-DTPA is tightly regulated due to its specialized use. The drug is available only by prescription and must be administered under the supervision of a physician. This strict regulation ensures that the drug is used appropriately but can also limit its availability and accessibility in certain scenarios[1][3].

Postmarketing Studies and Oversight

The FDA has mandated postmarketing studies to gather more data on the safety and efficacy of Zn-DTPA. However, the FDA's oversight of these studies has been criticized for being inadequate, with delays in reviewing annual submissions and a lack of comprehensive data to monitor study progress. This oversight is crucial for ensuring the long-term safety and effectiveness of the drug[2].

Financial Performance

The financial performance of Zn-DTPA is not as publicly scrutinized as that of more commercially oriented drugs. However, its approval and continued use are supported by government funding and public health initiatives. The drug's sales data is not typically disclosed in the same manner as more widely used pharmaceuticals, but it is clear that the revenue generated is sufficient to support ongoing production and research[4].

Market Competition

Given the specialized nature of Zn-DTPA, there is limited competition in the market. The drug is one of a few chelators approved for this specific use, and its competitors, such as pentetate calcium trisodium (Ca-DTPA), are often used in conjunction with or as alternatives to Zn-DTPA rather than direct competitors[1][3].

Regulatory Environment

The regulatory environment for Zn-DTPA is stringent, with the FDA playing a critical role in overseeing its use, labeling, and postmarketing surveillance. Changes in regulatory policies or additional data from postmarketing studies can impact the drug's labeling and usage guidelines, as seen in the revisions to the draft labeling in 2003 and subsequent updates[1][2].

Clinical Use and Administration

The clinical use of Zn-DTPA is highly regulated, with specific guidelines for administration. The drug is most effective when administered within the first 24 hours of exposure, and the dosage varies based on age and the route of administration (intravenous or nebulized). Monitoring for side effects, such as asthma exacerbation and trace metal depletion, is also crucial[3].

Safety and Efficacy

The safety and efficacy of Zn-DTPA have been established through clinical trials and postmarketing studies. However, there are specific warnings regarding asthma exacerbation with nebulization and the depletion of trace metals during prolonged therapy. These side effects necessitate careful monitoring and management[3].

Future Outlook

The future outlook for Zn-DTPA is tied to ongoing research and the need for radiological emergency preparedness. As nuclear safety and emergency response protocols evolve, the demand for effective chelators like Zn-DTPA is likely to remain steady. Advances in medical technology and changes in regulatory environments could also impact the drug's market dynamics and financial trajectory.

Key Takeaways

• Specialized Market: Zn-DTPA operates in a niche market focused on radiological emergencies.
• Regulatory Oversight: The FDA plays a critical role in regulating the use and postmarketing surveillance of Zn-DTPA.
• Clinical Use: The drug is highly effective when administered promptly and under medical supervision.
• Safety Considerations: Monitoring for side effects such as asthma exacerbation and trace metal depletion is essential.
• Financial Performance: Supported by government funding and public health initiatives, with limited public disclosure of sales data.

FAQs

What is the primary use of Pentetate Zinc Trisodium (Zn-DTPA)?

Pentetate Zinc Trisodium (Zn-DTPA) is primarily used for the treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination of these radioactive materials from the body.

When was Zn-DTPA approved by the FDA?

Zn-DTPA was approved by the FDA in 2004[3][4].

What are the potential side effects of Zn-DTPA?

Potential side effects include asthma exacerbation with nebulization and the depletion of trace metals during prolonged therapy[3].

How is Zn-DTPA administered?

Zn-DTPA can be administered intravenously or via nebulization, with specific dosages based on age and the timing of exposure[3].

Is Zn-DTPA available over-the-counter?

No, Zn-DTPA is available only by prescription and must be administered under the supervision of a physician[1][3].

Sources

1. FDA: Questions and Answers on Calcium-DTPA and Zinc-DTPA (Updated)[1].
2. GAO: New Drug Approval: FDA Needs to Enhance Its Oversight of Postmarketing Studies[2].
3. Drugs.com: Pentetate zinc trisodium: Package Insert / Prescribing Info[3].
4. Congress.gov: AGRICULTURE, RURAL DEVELOPMENT, AND RELATED AGENCIES APPROPRIATIONS BILL, 2005[4].