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Last Updated: February 26, 2020

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 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 four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Recent Litigation for bosutinib monohydrate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Wyeth LLC v. Sun Pharmaceutical Industries Limited2017-09-28
Wyeth LLC v. MSN Laboratories Private Limited2017-03-07
Wyeth LLC v. Sun Pharmaceutical Industries, Inc.2016-12-23

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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
AC-30573
AKOS027326604
BCP17036
BOSULIF
Bosulif (TN)
bosutinib hydrate
Bosutinib hydrate (JAN)
bosutinib.H2O
BXPOSPOKHGNMEP-UHFFFAOYSA-N
CHEBI:68533
D09728
DTXSID20238722
SCHEMBL2887945
SKI-606 monohydrate
UNII-844ZJE6I55
Paragraph IV (Patent) Challenges for BOSUTINIB MONOHYDRATE
Tradename Dosage Ingredient NDA Submissiondate
BOSULIF TABLET;ORAL bosutinib monohydrate 203341 2018-10-25
BOSULIF TABLET;ORAL bosutinib monohydrate 203341 2016-09-06

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

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

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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.