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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Argus Health
UBS
Dow
QuintilesIMS
Federal Trade Commission
Chubb
McKinsey

Generated: July 16, 2018

DrugPatentWatch Database Preview

Bosutinib monohydrate - Generic Drug Details

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What are the generic drug sources for bosutinib monohydrate and what is the scope of bosutinib monohydrate patent protection?

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

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

There are five drug master file entries for bosutinib monohydrate. Two suppliers are listed for this compound.
Pharmacology for bosutinib monohydrate
Synonyms for bosutinib monohydrate
3-Quinolinecarbonitrile, 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methyl-1-piperazinyl)propoxy)-, hydrate (1:1)
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-3-quinolinecarbonitrile monohydrate
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile monohydrate
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile monohydrate
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile--water (1/1)
844ZJE6I55
918639-08-4
AK322155
AKOS027326604
Bosulif (TN)
bosutinib hydrate
Bosutinib hydrate (JAN)
bosutinib.H2O
BXPOSPOKHGNMEP-UHFFFAOYSA-N
CHEBI:68533
D09728
DTXSID20238722
SCHEMBL2887945
SKI-606 monohydrate
UNII-844ZJE6I55

US Patents and Regulatory Information for bosutinib monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for bosutinib monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Try a Free Trial
8,445,496 Crystalline 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for bosutinib monohydrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140016 00110 Estonia ➤ Try a Free Trial PRODUCT NAME: BOSUTINIIB;REG NO/DATE: K(2013)1968 (LOPLIK) 02.04.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
McKesson
Moodys
Argus Health
Harvard Business School
US Department of Justice
Healthtrust
US Army
UBS

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