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Generated: November 21, 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
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.

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 0069-0135-01 120 TABLET, FILM COATED in 1 BOTTLE (0069-0135-01)
BOSULIF bosutinib monohydrate TABLET;ORAL 203341 NDA Pfizer Laboratories Div Pfizer Inc 0069-0136 0069-0136-01 30 TABLET, FILM COATED in 1 BOTTLE (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 203341-003 Oct 27, 2017 ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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