Malathion - Generic Drug Details

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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:	6,241
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

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Suven Pharms	MALATHION	malathion	LOTION;TOPICAL	091559-001	May 23, 2012		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	OVIDE	malathion	LOTION;TOPICAL	018613-001	Aug 2, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Norvium Bioscience	MALATHION	malathion	LOTION;TOPICAL	078743-001	Mar 6, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
World Intellectual Property Organization (WIPO)	2007005988		⤷ Sign Up
Japan	2013032405	PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE	⤷ Sign Up
European Patent Office	1898707	PROCEDE DE PREPARATION DE MALATHION DESTINE A UN USAGE PHARMACEUTIQUE (PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE)	⤷ Sign Up
Canada	2612578	PROCEDE DE PREPARATION DE MALATHION DESTINE A UN USAGE PHARMACEUTIQUE (PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE)	⤷ Sign Up
Japan	5474347		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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