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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Argus Health
QuintilesIMS
Moodys
Boehringer Ingelheim
Julphar
Cipla
Teva

Generated: May 25, 2018

DrugPatentWatch Database Preview

BOSULIF Drug Profile

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Which patents cover Bosulif, and what generic alternatives are available?

Bosulif is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-eight countries.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bosutinib monohydrate profile page.
Drug patent expirations by year for BOSULIF
Pharmacology for BOSULIF
Synonyms for BOSULIF
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 monohydrate
bosutinib.H2O
BXPOSPOKHGNMEP-UHFFFAOYSA-N
CHEBI:68533
D09728
DTXSID20238722
SCHEMBL2887945
SKI-606 monohydrate
UNII-844ZJE6I55

US Patents and Regulatory Information for BOSULIF

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 203341-002 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 203341-001 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 BOSULIF

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 203341-002 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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Paragraph IV (Patent) Challenges for BOSULIF
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 100mg and 500mg ➤ Subscribe 2016-09-06

Non-Orange Book US Patents for 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
8,445,496 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
6,297,258 Substituted 3-cyanoquinolines ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BOSULIF

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:

Dow
Moodys
Chinese Patent Office
Argus Health
Johnson and Johnson
Federal Trade Commission
Merck
Accenture
AstraZeneca

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