You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 28, 2024

Bosutinib monohydrate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Bosutinib monohydrate has eighty-one patent family members in thirty countries.

There is one drug master file entry for bosutinib monohydrate. Two suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bosutinib monohydrate
Generic Entry Dates for bosutinib monohydrate*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY
Dosage:
TABLET;ORAL
Generic Entry Dates for bosutinib monohydrate*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Strength NDA ANDAs Submitted Submissiondate
BOSULIF Tablets bosutinib monohydrate 400 mg 203341 1 2018-10-25
BOSULIF Tablets bosutinib monohydrate 100 mg and 500 mg 203341 2 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 CAPSULE;ORAL 217729-002 Sep 26, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate CAPSULE;ORAL 217729-002 Sep 26, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate CAPSULE;ORAL 217729-001 Sep 26, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for bosutinib monohydrate

Country Patent Number Title Estimated Expiration
Denmark 2478905 ⤷  Sign Up
Poland 1902029 ⤷  Sign Up
Russian Federation 2009144128 ЛЕЧЕНИЕ ЛЕЙКЕМИИ, УСТОЙЧИВОЙ К ИМАТИНИБУ, С ПРИМЕНЕНИЕМ 4-АМИНОХИНОЛИНА-3-КАРБОНИТРИЛА ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2007005462 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005046693 ⤷  Sign Up
Portugal 3002009 ⤷  Sign Up
European Patent Office 3002009 TRAITEMENT DE LEUCÉMIE RÉSISTANT À L'IMATINIB EN UTILISANT DES 4-AMINOQUINOLINE-3-CARBONITRILES (TREATMENT OF IMATINIB RESISTANT LEUKEMIA USING 4-AMINOQUINOLINE-3-CARBONITRILES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bosutinib monohydrate

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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.