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Last Updated: April 22, 2024

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BOSULIF Drug Patent Profile


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When do Bosulif patents expire, and what generic alternatives are available?

Bosulif is a drug marketed by Pf Prism Cv and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-one patent family members in thirty countries.

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.

DrugPatentWatch® Generic Entry Outlook for Bosulif

Bosulif was eligible for patent challenges on September 4, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 26, 2030. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for BOSULIF
Drug Prices for BOSULIF

See drug prices for BOSULIF

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BOSULIF
Generic Entry Dates for BOSULIF*:
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
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for BOSULIF*:
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
NDA:
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 BOSULIF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
City of Hope Medical CenterPhase 1
Roche Farma, S.APhase 1/Phase 2
Fundacion Espanola para la Curacion de la Leucemia Mieloide CronicaPhase 1/Phase 2

See all BOSULIF clinical trials

Pharmacology for BOSULIF
Paragraph IV (Patent) Challenges for BOSULIF
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 BOSULIF

BOSULIF is protected by five US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BOSULIF is ⤷  Try a Trial.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BOSULIF

Treatment of imatinib resistant leukemia
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted 3-cyanoquinolines
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting BOSULIF

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
Exclusivity Expiration: ⤷  Try a Trial

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)
Exclusivity Expiration: ⤷  Try a Trial

FOR THE 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
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 BOSULIF

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 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BOSULIF

When does loss-of-exclusivity occur for BOSULIF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4505
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 06266045
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0613574
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 13053
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1248047
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 96
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 14781
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 02029
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 078063
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 02029
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0600282
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 14614
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 09500332
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 08000384
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 080051
Estimated Expiration: ⤷  Try a Trial

Panama

Patent: 85101
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 070190
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 02029
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 02029
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 07148072
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 02029
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 080028386
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 49197
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 0740797
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BOSULIF around the world.

Country Patent Number Title Estimated Expiration
Canada 2613053 FORMES CRISTALLINES DE 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-METHOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARB-ONITRILE,ET LEURS PROCEDES DE PREPARATION (CRYSTALLINE FORMS OF 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-METHOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARBONITRILE ANDMETHODS OF PREPARING THE SAME) ⤷  Try a Trial
Russian Federation 2007148072 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 4-[(2,4-ДИХЛОР-5-МЕТОКСИФИНИЛ)АМИНО]-6- МЕОКСИ-7-[3-(4-МЕТИЛ-1-ПИПЕРАЗИНИЛ)ПРОПОКСИ]-3-ХИНАЛИНКАРБОНИТРИЛ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ ⤷  Try a Trial
Russian Federation 2009144128 ЛЕЧЕНИЕ ЛЕЙКЕМИИ, УСТОЙЧИВОЙ К ИМАТИНИБУ, С ПРИМЕНЕНИЕМ 4-АМИНОХИНОЛИНА-3-КАРБОНИТРИЛА ⤷  Try a Trial
Spain 2477567 ⤷  Try a Trial
Brazil PI0613574 forma cristalina isolada de um composto, método para preparar um composto, e, composição farmacêutica ⤷  Try a Trial
Taiwan 200908982 Treatment of imatinib resistant leukemia ⤷  Try a Trial
Singapore 146681 4-ANILINO-3-QUINOLINECARBONITRILES FOR THE TREATMENT OF CHRONIC MYELOGENOUS LEUKEMIA (CML) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BOSULIF

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

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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.