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Last Updated: December 23, 2024

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BOSULIF Drug Patent Profile


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Which patents cover Bosulif, and when can generic versions of Bosulif launch?

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

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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
Fundacion Espanola para la Curacion de la Leucemia Mieloide CronicaPhase 1/Phase 2
Roche Farma, S.APhase 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 ⤷  Subscribe.

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.

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>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 ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 ⤷  Subscribe ⤷  Subscribe
>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
Patent: 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
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 06266045
Patent: Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarb-onitrile and methods of preparing the same
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0613574
Patent: forma cristalina isolada de um composto, método para preparar um composto, e, composição farmacêutica
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 13053
Patent: 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)
Estimated Expiration: ⤷  Subscribe

China

Patent: 1248047
Patent: Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 96
Patent: FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL)PROPOXI]-3-QUINOLINOCARBONITRILO Y METODOS PARA SU PREPARACION
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 14781
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 02029
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 078063
Patent: FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL)PROPOXI]-3-QUINOLINOCARBONITRILO Y MÉTODOS PARA SU PREPARACIÓN
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 02029
Patent: FORMES CRISTALLINES DE 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-METHOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARB-ONITRILE, ET LEURS PROCÉDÉS DE PRÉPARATION (CRYSTALLINE FORMS OF 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-METHOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARB-ONITRILE AND METHODS OF PREPARING THE SAME)
Estimated Expiration: ⤷  Subscribe

Guatemala

Patent: 0600282
Patent: FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)-AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL)-PROPOXI]-3-QUINOLINCARBONITRILO Y METODOS PARA PREPARACION DE LAS MISMAS.
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 14614
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 09500332
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 08000384
Patent: FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOX I-7-[3-(4-METIL-1-PIPERAZINIL)PROPOXI]-3-QUINOLINOCARBONITRILO Y METODOS PARA SU PREPARACION. (CRYSTALLINE FORMS OF 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-ME THOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARB-ONIT RILE AND METHODS OF PREPARING THE SAME.)
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 080051
Estimated Expiration: ⤷  Subscribe

Panama

Patent: 85101
Patent: 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
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 070190
Patent: 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
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 02029
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 02029
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 07148072
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 4-[(2,4-ДИХЛОР-5-МЕТОКСИФИНИЛ)АМИНО]-6- МЕОКСИ-7-[3-(4-МЕТИЛ-1-ПИПЕРАЗИНИЛ)ПРОПОКСИ]-3-ХИНАЛИНКАРБОНИТРИЛ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 02029
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 080028386
Patent: CRYSTALLINE FORMS OF 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-METHOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARB-ONITRILE AND METHODS OF PREPARING THE SAME
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 49197
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 0740797
Patent: Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same
Estimated Expiration: ⤷  Subscribe

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
Poland 1902029 ⤷  Subscribe
Portugal 1902029 ⤷  Subscribe
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) ⤷  Subscribe
Japan 2016074700 4−アミノキノリン−3−カルボニトリルを使用するイマチニブ耐性白血病の処置 (TREATMENT OF IMATINIB RESISTANT LEUKEMIA USING 4-AMINOQUINOLINE-3-CARBONITRILES) ⤷  Subscribe
Ecuador SP078063 FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL)PROPOXI]-3-QUINOLINOCARBONITRILO Y MÉTODOS PARA SU PREPARACIÓN ⤷  Subscribe
Cyprus 1115251 ⤷  Subscribe
Japan 2014111629 TREATMENT OF IMATINIB-RESISTANT LEUKEMIA USING 4-AMINOQUINOLINE-3-CARBONITRILE ⤷  Subscribe
>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 ⤷  Subscribe PRODUCT NAME: BOSUTINIIB;REG NO/DATE: K(2013)1968 (LOPLIK) 02.04.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

BOSULIF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BOSULIF (Bosutinib)

Introduction

BOSULIF (bosutinib) is a tyrosine kinase inhibitor (TKI) developed by Pfizer, approved for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy. Here, we delve into the market dynamics and financial trajectory of BOSULIF.

Market Overview of CML Treatments

The global CML market is characterized by a mix of branded and generic TKIs. In 2020, the 8MM (eight major markets) CML market was valued at $4.25 billion, with expectations of peaking in 2023 before declining at a CAGR of more than -3% through 2030[1].

Key Players and Market Share

Pfizer, along with Novartis and Bristol Myers Squibb, is a significant player in the CML market. Novartis and BMS dominate the market with their second-generation TKIs, Tasigna (nilotinib) and Sprycel (dasatinib), respectively. Pfizer's presence is bolstered by BOSULIF, which targets a specific segment of CML patients who are resistant or intolerant to other TKIs[1].

Approval and Clinical Significance

BOSULIF was approved by the FDA in 2012 for patients with previously treated Ph+ CML. It is notable for being the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second-generation TKI. This approval highlights Pfizer's commitment to advancing cancer drug development and addressing unmet needs in the CML treatment landscape[4].

Target Patient Population

BOSULIF is designed for patients who have not responded well to initial therapies such as imatinib or second-generation TKIs. This niche positioning helps in capturing a specific market segment, particularly those with limited treatment options. The increasing prevalence of CML and the need for effective second-line treatments drive the demand for BOSULIF[4].

Financial Performance

The financial performance of BOSULIF is intertwined with Pfizer's overall oncology portfolio. While specific revenue figures for BOSULIF are not separately disclosed, it contributes to Pfizer's broader hematology and oncology segment. Pfizer's oncology drugs, including BOSULIF, are part of the company's growing pipeline, which is expected to drive future top-line growth[3].

Revenue Impact

Pfizer's revenue from its oncology segment, including BOSULIF, has been significant. However, the company's overall revenue has seen fluctuations, particularly due to the decline in sales of COVID-19 related products like Comirnaty and Paxlovid. Excluding these contributions, Pfizer's revenues from other products, including oncology drugs like BOSULIF, have shown operational growth[5].

Market Growth Drivers

Several factors drive the market growth for BOSULIF:

  • Approval and Launch of New Therapeutics: The approval of new agents, including BOSULIF, and the expansion of existing ones into new lines of therapy, contribute to market growth[1].
  • Increased Prevalence: The rising number of CML cases, expected to increase significantly by 2040, increases the demand for effective treatments like BOSULIF[4].
  • Adoption of Branded TKIs: The preference for branded second and third-generation TKIs over generic imatinib in many markets supports the sales of BOSULIF[1].

Challenges and Inhibitors

Despite these drivers, several challenges affect the financial trajectory of BOSULIF:

  • Patent Expiries: The patent expiries of many TKIs, including some of Pfizer's competitors, could lead to increased generic competition and reduce market share for branded drugs like BOSULIF[1].
  • Regulatory Pressures: Regulatory changes, such as the Inflation Reduction Act, could impact the pricing and revenue of branded drugs, including BOSULIF[3].

Geographic Market Dynamics

The US is the largest market for CML treatments, accounting for more than 60% of total CML sales in 2020. Pfizer's strong presence in the US market, combined with the slow growth in the 5EU, is expected to increase the US market share by 2030[1].

Expert Insights

"BOSULIF is an important new addition to the CML treatment landscape," said Dr. Jorge E. Cortes, deputy chair and professor of medicine at The University of Texas MD Anderson Cancer Center. "Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors."[4]

Key Takeaways

  • Niche Market Positioning: BOSULIF targets a specific segment of CML patients resistant or intolerant to other TKIs.
  • Clinical Significance: Approved with pivotal trial data including patients treated with imatinib followed by a second-generation TKI.
  • Financial Contribution: Part of Pfizer's growing oncology portfolio, contributing to operational growth excluding COVID-19 related products.
  • Market Drivers: Driven by new approvals, increased prevalence, and adoption of branded TKIs.
  • Challenges: Faces patent expiries and regulatory pressures.

FAQs

Q: What is BOSULIF used for? A: BOSULIF (bosutinib) is used for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy.

Q: When was BOSULIF approved by the FDA? A: BOSULIF was approved by the FDA in 2012.

Q: What makes BOSULIF unique in the CML treatment landscape? A: BOSULIF is the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second-generation TKI.

Q: How does BOSULIF contribute to Pfizer's revenue? A: BOSULIF contributes to Pfizer's broader hematology and oncology segment, driving operational growth excluding COVID-19 related products.

Q: What are the main challenges facing BOSULIF in the market? A: The main challenges include patent expiries of competing TKIs and regulatory pressures that could impact pricing and revenue.

Sources

  1. GlobalData: Chronic Myeloid Leukemia (CML): Global Drug Forecast and Market Analysis.
  2. Royalty Pharma: Royalty Pharma Reports First Quarter 2023 Results.
  3. University of Iowa: Krause Fund Research - Current Students.
  4. Pfizer: U.S. Food and Drug Administration Approves BOSULIF® (bosutinib) for Patients with Previously Treated Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (CML).
  5. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance.

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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.