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Malathion - Generic Drug Details

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Malathion is the generic ingredient in two branded drugs marketed by Taro Pharms North, Mylan Pharms Inc, and Suven Life, 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.

This ingredient has ten patent family members in seven countries.

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

Summary for Generic Name: malathion

Tradenames:2
Patents:2
Applicants:3
NDAs:3
Drug Master File Entries: see list3
Suppliers / Packaging: see list4
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: malathion

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro Pharms North
OVIDE
malathion
LOTION;TOPICAL018613-001Aug 2, 1982RXYes7,977,324► subscribeY ► subscribe
Mylan Pharms Inc
MALATHION
malathion
LOTION;TOPICAL078743-001Mar 6, 2009DISCNNo► subscribe► subscribe
Taro Pharms North
OVIDE
malathion
LOTION;TOPICAL018613-001Aug 2, 1982RXYes7,560,445► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: malathion

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,957,238Process for preparing malathion for pharmaceutical use► subscribe
8,039,657Process for preparing malathion for pharmaceutical use► subscribe
8,536,155Process for preparing malathion for pharmaceutical use► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: malathion

Country Document Number Estimated Expiration
European Patent Office1898707► subscribe
Canada2612578► subscribe
China101287374► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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