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Last Updated: January 21, 2021

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Details for New Drug Application (NDA): 203341

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NDA 203341 describes BOSULIF, which is a drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BOSULIF profile page.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this compound. Additional details are available on the bosutinib monohydrate profile page.
Summary for 203341
Tradename:BOSULIF
Applicant:Pf Prism Cv
Ingredient:bosutinib monohydrate
Patents:4
Generic Entry Opportunity Date for 203341
Generic Entry Date for 203341*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.

Paragraph IV (Patent) Challenges for 203341
Tradename Dosage Ingredient NDA Submissiondate
BOSULIF TABLET;ORAL bosutinib monohydrate 203341 2018-10-25
BOSULIF TABLET;ORAL bosutinib monohydrate 203341 2016-09-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Sep 4, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Dec 19, 2024
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Dec 11, 2025Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 203341

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   Start Trial   Start Trial
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
>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 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.