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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Chinese Patent Office
Medtronic
Harvard Business School
Citi
Merck
Chubb
Dow
Farmers Insurance

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
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:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Sep 4, 2012TE: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

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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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
QuintilesIMS
Chubb
Express Scripts
Julphar
Merck
Healthtrust
Cerilliant
Citi

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