Malathion - Generic Drug Details

What are the generic drug sources for malathion and what is the scope of freedom to operate?

Malathion is the generic ingredient in two branded drugs marketed by Norvium Bioscience, Suven Pharms, and Taro, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Malathion has nine patent family members in six countries.

There are three drug master file entries for malathion. Two suppliers are listed for this compound.

Summary for malathion

International Patents:	9
US Patents:	2
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	8
Patent Applications:	6,133
Drug Prices:	Drug price trends for malathion
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for malathion
What excipients (inactive ingredients) are in malathion?	malathion excipients list
DailyMed Link:	malathion at DailyMed

See drug prices for malathion

See drug sales revenues for malathion

Recent Clinical Trials for malathion

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

Sponsor	Phase
London School of Hygiene and Tropical Medicine	Phase 3
Taro Pharmaceuticals USA	Phase 1
Taro Pharmaceuticals USA	Phase 2/Phase 3

See all malathion clinical trials

Pharmacology for malathion

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for malathion

Cholinesterase Inhibitors

Insecticides

Anatomical Therapeutic Chemical (ATC) Classes for malathion

P03AX	Other ectoparasiticides, incl. scabicides
P03A	ECTOPARASITICIDES, INCL. SCABICIDES
P03	ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS
P	Antiparasitic products, insecticides and repellents

Paragraph IV (Patent) Challenges for MALATHION

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OVIDE	Topical Lotion	malathion	0.50%	018613	1	2011-03-16

US Patents and Regulatory Information for malathion

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	OVIDE	malathion	LOTION;TOPICAL	018613-001	Aug 2, 1982		DISCN	Yes	No			Y
Norvium Bioscience	MALATHION	malathion	LOTION;TOPICAL	078743-001	Mar 6, 2009		DISCN	No	No
Taro	OVIDE	malathion	LOTION;TOPICAL	018613-001	Aug 2, 1982		DISCN	Yes	No			Y	Y

International Patents for malathion

Country	Patent Number	Title	Estimated Expiration
China	103087095	Process for preparing malathion for pharmaceutical use, and combination thereof
Brazil	PI0612686	processo para preparar malation para uso farmacêutico
Japan	2013032405	PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE

Malathion Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Malathion

Market Overview

Malathion, a widely used organophosphate insecticide, is experiencing significant market dynamics driven by various factors. Here’s a detailed look at the current state and future projections of the malathion market.

Market Growth and Forecast

The malathion market is anticipated to grow at a rate of 5.5% from 2021 to 2028, reaching a market size of USD 0.53 billion by 2028[1][4].

Key Drivers of Growth

Increasing Demand for Food

The global rise in population and the subsequent increase in food demand are major drivers for the malathion market. As agricultural production needs to increase to meet this demand, the use of pesticides like malathion becomes more critical[1].

Broad Range of Pest Control Applications

Malathion's versatility in controlling a wide range of pests across different sectors, including agriculture and residential areas, contributes significantly to its market growth[1].

Decrease in Price and Ease of Accessibility

The reduction in the price of malathion and its ease of accessibility are further boosting its adoption, especially in regions where cost is a significant factor[1].

Market Segmentation

Product Segmentation

The malathion market is segmented into liquid, powder, emulsion, and other forms. Each form has its specific applications and market share, with liquid and powder forms being the most common[1].

Application Segmentation

The market is segmented based on application into agriculture, residential, and other sectors. The agriculture sector dominates the market due to the high demand for pest control in crop production[1].

Regional Analysis

Asia-Pacific

The Asia-Pacific region is expected to dominate the malathion market due to the significant growth in the agricultural sector and the increasing need for chemicals in this region[1].

Europe

Europe is also projected to see substantial growth, driven by the rising population and the presence of major key players in the region[1].

Challenges and Constraints

Health and Environmental Risks

Malathion poses risks to both human health and the environment, particularly affecting the nervous system of animals and humans. These risks are expected to impede market growth to some extent[1][5].

Safer Replacements and Regulatory Issues

The availability of safer pesticide alternatives and regulatory challenges, including those related to the use of malathion near endangered species, could also hinder market growth[1][2].

Competitive Landscape

The malathion market is competitive, with several key players such as Akzo Nobel N.V., Dow, Suven Life Sciences Limited, Paramount Pesticides Ltd., Lingyun Group, and Xinyi Taisong Chemical. These companies are focused on research and development, new market initiatives, and expanding their global presence[1].

Economic and Societal Impact

Economic Benefits

Malathion provides effective pest control, which is crucial for maintaining crop yields and ensuring food security. This has significant economic benefits, particularly for agricultural producers[3].

Societal Benefits

The use of malathion helps in controlling vector-borne diseases and protecting public health, which has broader societal benefits[5].

Regulatory Framework

The use of malathion is regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA has conducted risk assessments and issued risk management decisions to ensure that malathion-containing products are used safely and effectively[5].

Biological Opinion and Consultation

The U.S. Fish and Wildlife Service and the EPA have conducted extensive consultations and biological evaluations to assess the impact of malathion on endangered species and critical habitats. This process involves considering sublethal, indirect, and cumulative effects, as well as the use of geospatial information and datasets[2].

Financial Trajectory

Market Size and Revenue

The malathion market is expected to reach USD 0.53 billion by 2028, driven by the increasing demand in the agricultural and residential sectors[1].

Investment in Research and Development

Companies are investing in research and development to improve the efficacy and safety of malathion products. This investment is crucial for maintaining market competitiveness and addressing regulatory challenges[1].

Key Takeaways

• The malathion market is growing at a rate of 5.5% from 2021 to 2028.
• The market is driven by increasing food demand, broad pest control applications, and decreasing prices.
• Asia-Pacific and Europe are key regions driving market growth.
• Health and environmental risks, along with regulatory issues, pose challenges.
• The competitive landscape is dominated by several major players.
• Malathion has significant economic and societal benefits but is subject to strict regulatory oversight.

FAQs

What is the expected growth rate of the malathion market from 2021 to 2028?

The malathion market is expected to grow at a rate of 5.5% from 2021 to 2028[1].

Which regions are expected to dominate the malathion market?

The Asia-Pacific and Europe regions are expected to dominate the malathion market due to the growth in the agricultural sector and the presence of major key players[1].

What are the main challenges facing the malathion market?

The main challenges include health and environmental risks, the availability of safer pesticide alternatives, and regulatory issues[1][2].

Who are the key players in the malathion market?

Key players include Akzo Nobel N.V., Dow, Suven Life Sciences Limited, Paramount Pesticides Ltd., Lingyun Group, and Xinyi Taisong Chemical[1].

How does malathion impact the environment and human health?

Malathion poses risks to both human health and the environment, particularly affecting the nervous system of animals and humans. It also has potential impacts on endangered species and critical habitats[1][2][5].

Sources

1. Data Bridge Market Research: Global Malathion Market – Industry Trends and Forecast to 2028.
2. U.S. Fish and Wildlife Service: Biological and Conference Opinion on the Registration of Malathion.
3. USITC: Global Economic Impact of Missing and Low Pesticide Maximum Residue Levels.
4. DataM Intelligence: Malathion Market Size, Share, Industry Trends and Forecast 2023-2030.
5. EPA: Pesticides - Reregistration Eligibility Decision (RED) for Malathion.