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BOSULIF Drug Profile

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Bosulif is a drug marketed by Wyeth Pharms Inc and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in twenty-six countries.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bosutinib monohydrate profile page.

Summary for Tradename: BOSULIF

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: BOSULIF

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms Inc
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-001Sep 4, 2012RXYes6,002,008► subscribeYY ► subscribe
Wyeth Pharms Inc
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-001Sep 4, 2012RXYes► subscribe► subscribe
Wyeth Pharms Inc
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-001Sep 4, 2012RXYesRE42376► subscribeY ► subscribe
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Paragraph IV activity for: BOSULIF

Drugname Dosage Strength RLD Submissiondate
bosutinibTablets100mg and 500mgBosulif9/6/2016

Non-Orange Book Patents for Tradename: BOSULIF

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
8,445,496Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same► subscribe
6,297,258 Substituted 3-cyanoquinolines► 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 Tradename: BOSULIF

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005046693► subscribe
Australia2003291245► subscribe
European Patent Office1902029► 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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Supplementary Protection Certificates for Tradename: BOSULIF

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140016 00110Estonia► subscribePRODUCT NAME: BOSUTINIIB;REG NO/DATE: K(2013)1968 (LOPLIK) 02.04.2013
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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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