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Last Updated: May 26, 2022

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 one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-three patent family members in thirty-one 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 November 23, 2026. 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 Generic Entry Opportunity Date for BOSULIF
Generic Entry Date for BOSULIF*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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

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 six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BOSULIF is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING A BCRABL POSITIVE LEUKEMIA IN A SUBJECT THAT IS RESISTANT TO IMATINIB COMPRISING ADMINISTERING TO THE SUBJECT A THERAPEUTICALLY EFFECTIVE AMOUNT OF BOSUTINIB, WHEREIN THE SUBJECT HAS A MUTATION IN THE BCRABL PROTEIN AT 949T>C

Treatment of imatinib resistant leukemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING A BCRABL POSITIVE LEUKEMIA IN A SUBJECT THAT IS RESISTANT TO IMATINIB COMPRISING ADMINISTERING TO THE SUBJECT A THERAPEUTICALLY EFFECTIVE AMOUNT OF BOSUTINIB, WHEREIN THE SUBJECT HAS A MUTATION IN THE BCRABL PROTEIN AT F317L

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted 3-cyanoquinolines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BOSULIF

TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)
Exclusivity Expiration: See Plans and Pricing

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 203341-001 Sep 4, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 203341-001 Sep 4, 2012 See Plans and Pricing See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 See Plans and Pricing See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 06266045
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0613574
Estimated Expiration: See Plans and Pricing

Canada

Patent: 13053
Estimated Expiration: See Plans and Pricing

China

Patent: 1248047
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 96
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14781
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 02029
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 078063
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 02029
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0600282
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 14614
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8483
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09500332
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08000384
Estimated Expiration: See Plans and Pricing

Norway

Patent: 080051
Estimated Expiration: See Plans and Pricing

Panama

Patent: 85101
Estimated Expiration: See Plans and Pricing

Peru

Patent: 070190
Estimated Expiration: See Plans and Pricing

Poland

Patent: 02029
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 02029
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 07148072
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 02029
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 080028386
Estimated Expiration: See Plans and Pricing

Spain

Patent: 49197
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 0740797
Estimated Expiration: See Plans and Pricing

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
Spain 2881391 See Plans and Pricing
European Patent Office 2478905 Traitement de leucémie résistant à l'imatinib en utilisant des 4-aminoquinoline-3-carbonitriles (Treatment of imatinib resistant leukemia using 4-aminoquinoline-3-carbonitriles) See Plans and Pricing
Spain 2477567 See Plans and Pricing
Brazil PI0812355 TRATAMENTO DE LEUCEMIA RESISTENTE A IMATINIB See Plans and Pricing
European Patent Office 2777704 Traitement de leucémie résistant à l'imatinib en utilisant des 4-aminoquinoline-3-carbonitriles (Treatment of imatinib resistant leukemia using 4-aminoquinoline-3-carbonitriles) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005047259 See Plans and Pricing
Panama 8685101 FORMAS CRISTALINAS DE 4-[2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL) PROPOXI]-3-QUINOLINCARBONITRILO Y METODOS DE PREPARACION DE LAS MISMAS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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