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Last Updated: September 23, 2021

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Bosutinib monohydrate - Generic Drug Details

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What are the generic sources for bosutinib monohydrate and what is the scope of freedom to operate?

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.

Summary for bosutinib monohydrate
Recent Clinical Trials for bosutinib monohydrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1

See all bosutinib monohydrate clinical trials

Pharmacology for bosutinib monohydrate
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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 ⤷  Try it Free ⤷  Try it Free
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for bosutinib monohydrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1902029 C20140016 00110 Estonia ⤷  Try it Free PRODUCT NAME: BOSUTINIIB;REG NO/DATE: K(2013)1968 (LOPLIK) 02.04.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
McKesson
Mallinckrodt
Harvard Business School
Johnson and Johnson

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