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Serving leading biopharmaceutical companies globally:

Moodys
QuintilesIMS
Merck
Chubb
Cipla
Dow
Colorcon
Fuji
McKesson
McKinsey

Generated: December 14, 2017

DrugPatentWatch Database Preview

Malathion - Generic Drug Details

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

Malathion
is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Suven Life, and Taro Pharm, 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 ten patent family members in seven countries.

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

Pharmacology for malathion

Medical Subject Heading (MeSH) Categories for malathion

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Taro PharmOVIDEmalathionLOTION;TOPICAL018613-001Aug 2, 1982ATRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Taro PharmOVIDEmalathionLOTION;TOPICAL018613-001Aug 2, 1982ATRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Suven LifeMALATHIONmalathionLOTION;TOPICAL091559-001May 23, 2012ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMALATHIONmalathionLOTION;TOPICAL078743-001Mar 6, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe► 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
8,039,657Process for preparing malathion for pharmaceutical use► Subscribe
8,957,238Process 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
World Intellectual Property Organization (WIPO)2007005988► Subscribe
China101287374► Subscribe
Israel188512► Subscribe
China103087095► Subscribe
European Patent Office1898707► Subscribe
Japan2009500422► Subscribe
Canada2612578► Subscribe
Japan2013032405► Subscribe
BrazilPI0612686► Subscribe
Japan5474347► 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Johnson and Johnson
Chubb
McKesson
Citi
Merck
Cerilliant
Queensland Health
US Army

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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