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Generated: May 25, 2018

DrugPatentWatch Database Preview

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. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. 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. Two suppliers are listed 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:	5

Pharmacology for NDA: 203341

Mechanism of Action	Protein Kinase Inhibitors P-Glycoprotein Inhibitors

Suppliers and Packaging for NDA: 203341

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0135	N	0069-0135-01
BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0136	N	0069-0136-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Sep 4, 2012	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 4, 2019
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH CHRONIC, ACCELERATED OR BLAST PHASE PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOGENOUS LEUKEMIA (CML) WITH RESISTANCE, OR INTOLERANCE TO PRIOR THERAPY
Regulatory Exclusivity Expiration:	Dec 19, 2024
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)
Regulatory Exclusivity Expiration:	Dec 19, 2020
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+CML)

Expired US Patents for NDA 203341

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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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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.