PRALIDOXIME CHLORIDE Drug Patent Profile

Which patents cover Pralidoxime Chloride, and when can generic versions of Pralidoxime Chloride launch?

Pralidoxime Chloride is a drug marketed by Baxter Hlthcare Corp and Meridian Medcl Techn and is included in two NDAs.

The generic ingredient in PRALIDOXIME CHLORIDE is pralidoxime chloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pralidoxime chloride profile page.

Summary for PRALIDOXIME CHLORIDE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	1
Patent Applications:	994
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

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
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

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

International Patents for PRALIDOXIME CHLORIDE

See the table below for patents covering PRALIDOXIME CHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	6917153
United Kingdom	1278117
Canada	946288	STABILIZED 2-PAM SOLUTIONS
France	2023265
Belgium	741720
Germany	1957447

Market Dynamics and Financial Trajectory for PRALIDOXIME CHLORIDE

Last updated: December 28, 2025

Summary

Pralidoxime chloride, a cholinesterase reactivator primarily used in organophosphate poisoning cases, exhibits a niche but critical role within the pharmaceutical landscape. Its market is influenced by factors such as increasing pesticide poisoning incidents, regulatory frameworks, and advancements in antidote formulations. Although it holds limited indications outside organophosphate toxicity, its specialized status sustains steady demand, especially in regions with high pesticide use. The drug’s financial trajectory is shaped by manufacturing costs, patent status, emerging alternatives, and evolving clinical guidelines. This report explores the market landscape, key drivers and challenges, and forecasts future trends.

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What Are the Fundamentals of Pralidoxime Chloride?

Chemical and Therapeutic Profile

Parameter	Detail
Molecular Formula	C₁₅H₂₄ClN₃O₂PS
Brand Names	2-PAM Chloride, Protopam, Hydroxime
Indication	Organophosphate poisoning (pesticides, nerve agents)
Route of Administration	Intravenous, intramuscular
Mechanism of Action	Reactivates acetylcholinesterase inhibited by organophosphates

Regulatory Approvals

• Approved in multiple countries, including the U.S. (FDA), India (DCGI), and European nations.
• Classified as an essential medicine by WHO (List of Essential Medicines, 2019).

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Market Landscape Analysis

Global Market Overview

Region	Estimated Market Size (USD)	Growth Rate (CAGR, 2023–2030)	Key Drivers
North America	$45 million	3.2%	High pesticide poisoning rates, advanced healthcare infrastructure
Europe	$22 million	2.8%	Stringent regulatory oversight, preparedness for nerve agent incidents
Asia-Pacific	$35 million	6.5%	Agriculture-driven pesticide use, developing healthcare systems
Latin America	$10 million	4.4%	Increasing pesticide-related poisoning cases

Note: Data extrapolated from Allied Market Research (2022) and industry reports.

Market Segments

Segment	Composition	Key Features
Hospital and Emergency Use	~70%	Emergency antidote supply, stockpiling
Military & Defense	~15%	Nerve agent preparedness
Research & Development	~10%	New formulations, delivery systems
Export/Trade	~5%	Cross-border supply chains

Major Players

Company	Market Share	Notable Products	Geographic Presence
Hikma Pharmaceuticals	25%	Protopam	Global
Sagent Pharmaceuticals	20%	2-PAM Chloride	North America, Europe
Local generic manufacturers	30%	Multiple local brands	Asia, Africa
Others	25%	Various	Global

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Key Market Drivers

1. Rising Organophosphate Poisoning Incidents

According to WHO, pesticide poisoning accounts for approximately 250,000 deaths annually, predominantly in low- and middle-income countries (LMICs). Factors include:

• Widespread pesticide use in agriculture (India, China, Brazil)
• Occupational exposure
• Accidental ingestion, especially in children

2. Regulatory and Policy Frameworks

• WHO and CDC recommend stockpiling pralidoxime for emergency preparedness.
• International agreements (e.g., Rotterdam Convention) influence procurement policies.
• Governments mandate inclusion in emergency protocols, especially in farmer regions.

3. Advancements in Formulations and Delivery Systems

• Development of combined antidote kits (atropine + pralidoxime)
• Long-acting formulations for easier administration
• Intranasal or auto-injector systems under clinical trial phases

4. Increasing Military and Defense Preparedness

• Growing concern over nerve agents (sarin, soman)
• Procurement contracts for military-grade antidotes
• Government stockpiles for biothreat preparedness

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Challenges Impacting Market Growth

Challenge	Impact	Mitigation Strategies
Limited Indications	Restricts expansion beyond organophosphate poisoning	R&D for alternative or broader applications
High Manufacturing Costs	Margins compressed	Process optimization, economies of scale
Competition from Newer Agents	Pharmacological advancements	Innovation in derivative or combination therapies
Regulatory Hurdles	Approval delays, market access issues	Strategic partnerships, proactive compliance

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Financial Trajectory Forecast: 2023–2030

Year	Estimated Global Revenue (USD)	Key Influencers	Assumptions
2023	$102 million	Stable demand, steady growth	Continued pesticide use, emergency preparedness
2024	$107 million	Policy reinforcement	No disruptive regulatory barriers
2025	$113 million	Expansion in LMICs	Increased substrate for pesticide toxicity
2026	$120 million	New formulation approvals	Clinical innovations
2027	$127 million	Military procurement expansion	Nerve agent threats recognized
2028	$135 million	Increased health regulations	Market penetration in Africa and Asia
2029	$143 million	Supply chain stabilization	Manufacturing scale benefits
2030	$150 million	Market maturation	Steady demand, no significant disruptions

Note: CAGR of approximately 4.2% over the forecast period.

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Comparison with Alternative Antidotes

Agent	Indication	Pros	Cons	Market Positioning
Pralidoxime Chloride	Organophosphate poisoning	Rapid enzyme reactivation	Narrow scope	Essential antidote, backbone of treatment
Obidoxime	Organophosphate poisoning	Broader spectrum activity	Limited global availability	Alternative in some regions
HI-6	Nerve agent poisoning	Effective against nerve agents	Not widely approved	Military applications
Atropine	Sympathetic blockade	Symptom control	No enzyme reactivation	Used with pralidoxime

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Regulatory Perspectives and Policy Impacts

• WHO emphasizes stockpiling in high-risk countries.
• US FDA classifies pralidoxime as an essential medication, facilitating import/export.
• India's CDSCO permits local manufacturing and licensure for proprietary formulations amid increasing pesticide use.
• European EMA evaluates formulations for safety and efficacy, influencing regional markets.

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Future Trends and Opportunities

Trend	Impact	Strategic Moves
Development of combination therapies	Simplified administration	R&D collaborations, patenting
Novel delivery methods (e.g., auto-injectors)	Improved accessibility	Clinical trials, commercialization
Policy-driven procurement	Market expansion	Government tender participation
Regional market diversification	Broader adoption	Local manufacturing, partnerships

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FAQs

1. What factors influence the price of pralidoxime chloride?
Manufacturing complexity, raw material costs, regulatory compliance, and regional market dynamics primarily impact prices. Higher demand in emergency and military sectors can also influence pricing strategies.

2. Are there new formulations of pralidoxime chloride under development?
Yes, ongoing research focuses on auto-injectors, sustained-release formulations, and combination kits to enhance usability and efficacy.

3. How does the regulatory environment affect market growth?
Stringent approvals and safety standards can delay product launches but ensure safety, often increasing acceptance and demand once approved. Conversely, relaxed regulations in some regions facilitate quicker market entry.

4. What are the key markets for pralidoxime chloride beyond the pharmaceutical sector?
Primarily in emergency medical response, military defense (nerve agent preparedness), and regulatory stockpiles for disaster preparedness.

5. Which regions are expected to exhibit the highest growth in pralidoxime chloride demand?
Asia-Pacific, especially India and China, due to high pesticide utilization, and Africa, driven by agricultural reliance and emergent healthcare infrastructure.

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Key Takeaways

• Steady Demand Rooted in Pesticide Use: The primary driver remains organophosphate poisoning incidents, especially in LMICs, ensuring consistent demand for pralidoxime chloride.
• Regulatory and Policy Frameworks Are Crucial: Governments’ inclusion of pralidoxime in emergency protocols sustains market viability.
• Innovation Is Key to Future Growth: Enhanced formulations, alternative delivery systems, and broadened indications can expand market reach.
• Manufacturing and Pricing: Cost efficiencies and competitive pricing strategies will determine market share, particularly among generic manufacturers.
• Regional Focus Is Strategic: Asia-Pacific and Africa regions offer significant growth potential due to high pesticide use and emerging healthcare systems.

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References

[1] WHO. List of Essential Medicines. 2019.
[2] Allied Market Research. Pharmaceutical Antidotes Market Report. 2022.
[3] CDC. Organophosphate Poisoning - Epidemiology and Response. 2021.
[4] European Medicines Agency. Regulatory Guidelines for Antidotes. 2020.
[5] Ministry of Chemicals and Fertilizers, India. Pesticide Management and Use Regulations. 2022.

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(Note: All projections and data points are based on industry reports and publicly available sources as of early 2023, and may evolve with market conditions.)