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Bosutinib monohydrate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for bosutinib monohydrate?

Bosutinib monohydrate is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bosutinib monohydrate has forty patent family members in twenty-seven countries.

There are five drug master file entries for bosutinib monohydrate. Two suppliers are listed for this compound.

Summary for Generic Name: bosutinib monohydrate

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list2
Bulk Api Vendors: see list3
Clinical Trials: see list48
Patent Applications: see list3
Drug Prices:see low prices
DailyMed Link:bosutinib monohydrate at DailyMed

Pharmacology for Ingredient: bosutinib monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-002Sep 4, 2012RXYesNo► Subscribe► Subscribe
Pf Prism Cv
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-002Sep 4, 2012RXYesNo7,919,625► SubscribeY ► Subscribe
Pf Prism Cv
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-001Sep 4, 2012RXYesYes7,417,148► Subscribe ► Subscribe
Pf Prism Cv
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-001Sep 4, 2012RXYesYes7,767,678► SubscribeYY ► Subscribe
Pf Prism Cv
BOSULIF
bosutinib monohydrate
TABLET;ORAL203341-001Sep 4, 2012RXYesYes► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: bosutinib monohydrate

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
6,297,258 Substituted 3-cyanoquinolines► Subscribe
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
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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: bosutinib monohydrate

Country Document Number Estimated Expiration
Norway20080051► Subscribe
Canada2543163► Subscribe
Taiwan200740797► Subscribe
Canada2613053► Subscribe
China1874776► 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: BOSUTINIB MONOHYDRATE

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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