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Last Updated: April 25, 2024

MALATHION - Generic Drug Details

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What are the generic sources for malathion and what is the scope of patent protection?

Malathion is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, 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:	6,143
Formulation / Manufacturing:	see details
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

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Suven Pharms	MALATHION	malathion	LOTION;TOPICAL	091559-001	May 23, 2012		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	OVIDE	malathion	LOTION;TOPICAL	018613-001	Aug 2, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Mylan Pharms Inc	MALATHION	malathion	LOTION;TOPICAL	078743-001	Mar 6, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for MALATHION

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Country	Patent Number	Title	Estimated Expiration
China	103087095	Process for preparing malathion for pharmaceutical use, and combination thereof	⤷ Try a Trial
Japan	5474347		⤷ Try a Trial
European Patent Office	1898707	PROCEDE DE PREPARATION DE MALATHION DESTINE A UN USAGE PHARMACEUTIQUE (PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE)	⤷ Try a Trial
Canada	2612578	PROCEDE DE PREPARATION DE MALATHION DESTINE A UN USAGE PHARMACEUTIQUE (PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE)	⤷ Try a Trial
China	101287374	Process for preparing malathion for pharmaceutical use	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007005988		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.