PRALIDOXIME CHLORIDE - Generic Drug Details

What are the generic sources for pralidoxime chloride and what is the scope of freedom to operate?

Pralidoxime chloride is the generic ingredient in three branded drugs marketed by Baxter Hlthcare Corp, Meridian Medcl Techn, and Wyeth Ayerst, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for pralidoxime chloride. One supplier is listed for this compound.

Summary for PRALIDOXIME CHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	1
Patent Applications:	1,336
What excipients (inactive ingredients) are in PRALIDOXIME CHLORIDE?	PRALIDOXIME CHLORIDE excipients list
DailyMed Link:	PRALIDOXIME CHLORIDE at DailyMed

Recent Clinical Trials for PRALIDOXIME CHLORIDE

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

Sponsor	Phase
Sir Salimullah Medical College Mitford Hospital	Phase 2

See all PRALIDOXIME CHLORIDE clinical trials

Pharmacology for PRALIDOXIME CHLORIDE

Drug Class	Cholinesterase Reactivator
Mechanism of Action	Cholinesterase Reactivators

Anatomical Therapeutic Chemical (ATC) Classes for PRALIDOXIME CHLORIDE

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for PRALIDOXIME CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	PROTOPAM CHLORIDE	pralidoxime chloride	TABLET;ORAL	014122-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare Corp	PRALIDOXIME CHLORIDE	pralidoxime chloride	INJECTABLE;INJECTION	018799-001	Dec 13, 1982		DISCN	No	No
Meridian Medcl Techn	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	pralidoxime chloride	SOLUTION;INTRAMUSCULAR	018986-001	Apr 26, 1983		DISCN	Yes	No
Baxter Hlthcare Corp	PROTOPAM CHLORIDE	pralidoxime chloride	INJECTABLE;INJECTION	014134-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for PRALIDOXIME CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	PRALIDOXIME CHLORIDE	pralidoxime chloride	INJECTABLE;INJECTION	018799-001	Dec 13, 1982	3,629,425

PRALIDOXIME CHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pralidoxime Chloride

Market Overview

Pralidoxime chloride, a phosphorus-based organic chemical, is a critical antidote for nerve agent and organophosphate poisoning. The market for pralidoxime chloride is experiencing significant growth driven by several key factors.

Market Size and Growth Projections

• The global pralidoxime chloride market is anticipated to witness a Compound Annual Growth Rate (CAGR) of 4.5% from 2021 to 2028, reaching a market size of approximately USD 1,596.21 million by 2028[1].
• For the extended forecast period of 2023 to 2031, the market is expected to continue its upward trajectory, with substantial growth rates projected[3].

Segmentation and Applications

By Purity

• The pralidoxime chloride market is segmented based on purity levels of 0.97, 0.98, and 0.99. Each purity level has different applications and demand dynamics[1][3].

By Application

• The market is segmented into pharmaceutical, chemicals, and other applications. The pharmaceutical segment is a major driver due to the drug's use as an antidote for nerve agent poisoning[1][3].

By Type (For Injection Market)

• The pralidoxime chloride injection market is segmented into intravenous drip and intramuscular injection types. These types cater to different medical needs and emergency response scenarios[2].

By Geography

• The market is analyzed across various geographical regions including North America, Europe, Asia-Pacific, South America, and Middle East and Africa. Middle East and Africa dominate the market due to frequent riots and terrorist activities, while Europe and North America are expected to show the highest CAGR due to high demand and increased production capacities[1][3].

Drivers of Market Growth

Increasing Incidence of Biological and Chemical Threats

• The rising incidence of biological and chemical warfare, along with the high usage of cyanogenetic chemicals in weapons, is a significant driver for the pralidoxime chloride market[1].

Growing Demand for Antidotes

• Frequent civil wars and riots in various countries have increased the demand for antidotes for chemical weapons, thereby boosting the sales of pralidoxime chloride[1].

Technological Innovations

• Advances in autoinjector technology, such as the ARAI autoinjector developed by Aktiv Pharma Group, enhance usability, reliability, and drug stability, contributing to market growth[5].

Restraints and Challenges

Regulatory Approvals

• Rigorous regulatory approvals for pralidoxime chloride products can hinder market growth. The development and approval process for these antidotes is complex and costly[1].

Distribution Channels

• Slim distribution channels can limit the accessibility of pralidoxime chloride, affecting its market expansion[1].

Key Players and Market Landscape

• The global pralidoxime chloride market is highly consolidated, with a few major players such as Baxter International, Beijing Wellso Pharmaceutical, and Aktiv Pharma Group dominating the market. These companies are investing heavily in research and development to enhance their product offerings and market presence[2][5].

Financial Trajectory

Contract Awards and Government Support

• Significant financial support from government contracts, such as the contract awarded to Aktiv Pharma Group by the U.S. Department of Health and Human Services valued up to $220 million, underscores the financial viability and growth potential of the market[5].

Market Size Projections

• The market size is projected to grow substantially, with the global market valued at approximately USD 200 million in 2023 and expected to reach higher values by 2031[4].

Regional Analysis

Middle East and Africa

• This region dominates the pralidoxime chloride market due to frequent riots, rising terrorist activities, and high demand from various end-user industries[1].

Europe and North America

• These regions are expected to project the highest CAGR during the forecast period due to high demand for pralidoxime chloride and increased production capacities of leading companies[1].

Market Dynamics and Trends

Market Opportunities

• The increasing need for effective antidotes against chemical and biological threats presents significant market opportunities. The development of advanced autoinjector technologies further enhances these opportunities[2][5].

Market Challenges

• Despite the growth potential, the market faces challenges such as rigorous regulatory approvals and limited distribution channels. Addressing these challenges is crucial for sustained market growth[1].

"The ARAI autoinjector has been developed by Aktiv with the support of the Department of Defense (DoD) and BARDA as a next generation autoinjector platform to address the shortfalls of previous autoinjectors, by improving usability, reliability, robustness, and drug stability."[5]

Conclusion

The pralidoxime chloride market is poised for significant growth driven by increasing threats of chemical and biological warfare, technological innovations, and government support. However, the market must navigate challenges such as regulatory hurdles and distribution limitations to realize its full potential.

Key Takeaways

• Market Growth: The pralidoxime chloride market is expected to grow at a CAGR of 4.5% from 2021 to 2028.
• Segmentation: The market is segmented by purity, application, and geography.
• Drivers: Increasing incidence of biological and chemical threats, growing demand for antidotes, and technological innovations.
• Restraints: Rigorous regulatory approvals and slim distribution channels.
• Key Players: Companies like Baxter International, Beijing Wellso Pharmaceutical, and Aktiv Pharma Group.
• Financial Trajectory: Significant government contracts and projected market size growth.

FAQs

1. What is the primary use of pralidoxime chloride?

   • Pralidoxime chloride is primarily used as an antidote for nerve agent and organophosphate poisoning.

2. Which regions dominate the pralidoxime chloride market?

   • Middle East and Africa dominate the market, while Europe and North America are expected to show the highest CAGR.

3. What are the key drivers of the pralidoxime chloride market?

   • The key drivers include increasing incidence of biological and chemical threats, growing demand for antidotes, and technological innovations.

4. What are the major challenges facing the pralidoxime chloride market?

   • The major challenges include rigorous regulatory approvals and limited distribution channels.

5. Which companies are major players in the pralidoxime chloride market?

   • Major players include Baxter International, Beijing Wellso Pharmaceutical, and Aktiv Pharma Group.

Sources

1. Data Bridge Market Research - Global Pralidoxime Chloride Market – Industry Trends and Forecast to 2028.
2. Market Research Intellect - Global Pralidoxime Chloride Injection Market Size, Trends and Forecast Report.
3. Market Research Intellect - Global Pralidoxime Chloride Market Size, Scope And Forecast Report.
4. Dataintelo - Pralidoxime Chloride Market Research Report 2032.
5. PRWeb - Aktiv Pharma Group wins contract valued at up to $220 million to supply life-saving emergency autoinjectors to the Strategic National Stockpile.