BOSULIF Drug Patent Profile

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 four 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^® Litigation and Generic Entry Outlook for Bosulif

A generic version of BOSULIF was approved as bosutinib monohydrate by ALEMBIC on May 23^rd, 2025.

Summary for BOSULIF

International Patents:	81
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	16
Patent Applications:	6,496
Drug Prices:	Drug price information for BOSULIF
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BOSULIF
What excipients (inactive ingredients) are in BOSULIF?	BOSULIF excipients list
DailyMed Link:	BOSULIF at DailyMed

See drug prices for BOSULIF

Recent Clinical Trials for BOSULIF

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
Roche Farma, S.A	Phase 1/Phase 2
Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica	Phase 1/Phase 2

See all BOSULIF clinical trials

Pharmacology for BOSULIF

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors

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 four US patents and seven FDA Regulatory Exclusivities.

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	AB	RX	Yes	No
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	AB	RX	Yes	No
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No	7,767,678*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No	7,417,148*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-001	Sep 26, 2023		RX	Yes	No	11,103,497*PED				Y

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	6,002,008
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017	6,002,008
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	6,002,008

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

Canada

Norway

Spain

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
South Korea	20080028386	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
South Korea	101493543
Guatemala	200600282	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.
Brazil	PI0812355
Japan	2010529038
Hong Kong	1114614	-二氯- -甲氧苯基 氨基 -甲氧基- -甲基- -哌嗪基 丙氧基 -喹啉腈之晶體形式及其之製備方法 (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 4-[(24--5-)]-6--7-[3-(4--1-)]-3-)
China	1874776	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)

Supplementary Protection Certificates for BOSULIF

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

Market Dynamics and Financial Trajectory for Bosulif (Bosutinib)

Last updated: July 27, 2025

Introduction

Bosulif (bosutinib) is an oral tyrosine kinase inhibitor developed by Pfizer, primarily approved for the treatment of chronic myeloid leukemia (CML), including Philadelphia chromosome-positive (Ph+) CML in adult patients. Since its FDA approval in 2012, Bosulif has carved a niche within the targeted cancer therapy landscape, driven by evolving clinical data, competitive pressure, regulatory developments, and broader market trends in oncology therapeutics.

This analysis explores the market dynamics influencing Bosulif’s trajectory and projects its financial outlook amid competitive, regulatory, and innovation-driven forces.

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Market Overview and Therapeutic Positioning

Indication and Clinical Utility

Bosulif is indicated for treatment-resistant or intolerant Ph+ CML patients, particularly those who have failed prior therapy with other tyrosine kinase inhibitors (TKIs). Its mechanism targets BCR-ABL kinase activity, which is crucial in CML pathology. The increasing prevalence of CML globally, complemented by an expanding base of eligible patients, sustains demand for effective TKI therapies.

Competitive Landscape

Bosulif faces competition from several other TKIs, including imatinib, dasatinib, nilotinib, ponatinib, and later-generation agents like asciminib. The competitive environment influences product uptake, pricing, and physician prescribing patterns, especially as newer agents demonstrate improved safety profiles or efficacy in resistant cases.

Market Penetration and Usage Trends

According to IQVIA data, Bosulif's market share within the CML treatment landscape remains modest, partly due to clinicians’ preference for first-line therapies like imatinib and subsequent lines for resistant cases. Its niche positioning as a second- or third-line agent constrains its volume growth but preserves steady revenue streams.

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Regulatory and Scientific Developments Impacting Market Dynamics

Approvals and Label Extensions

While initially approved for second-line treatment, subsequent extensions, or label modifications, may influence adoption. In 2017, the FDA approved Bosulif for adult patients with newly diagnosed Philadelphia chromosome-positive chronic, accelerated, or blast phase CML based on compelling phase 3 data, broadening its deployment.

Clinical Trials and Evolving Data

Ongoing trials exploring Bosulif in combination therapies or in other hematologic malignancies have potential to expand its indications. Positive results could catalyze increased utilization, though competition remains high for such indications.

Safety Profile and Tolerability

Bosulif's adverse event profile influences its market uptake. Its mitochondrial toxicity profile and adverse events such as diarrhea, elevated liver enzymes, and myelosuppression impact physician prescribing, especially when safer alternatives exist.

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Market Drivers and Constraints

Drivers

• Increasing CML Incidence: As global populations age, the prevalence of CML grows, enlarging the patient pool needing effective treatments.
• Resistance to First-Generation TKIs: Resistance patterns push clinicians toward second-generation inhibitors like Bosulif.
• Regulatory Approvals: Expanded indications in multiple phases of CML and potential future approvals for novel indications bolster market prospects.
• Patient Compliance: Oral administration supports better adherence, influencing marketability.

Constraints

• Intense Competition: The crowded TKI landscape, especially with agents like ponatinib and asciminib, limits market share.
• Pricing Pressures: Payers demand cost-effective therapies, often favoring generics or less costly options.
• Limited First-Line Role: Bosulif’s niche as a second- or third-line option constrains growth potential.

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Financial Trajectory and Revenue Outlook

Current Revenue Performance

Pfizer’s revenue data indicates that Bosulif’s contribution remains steady but modest within its oncology portfolio. In 2022, estimated global sales hovered around a few hundred million dollars, reflecting its niche positioning.

Long-Term Growth Drivers

• Market Penetration Expansion: Increased adoption in resistant CML cases as clinician familiarity grows.
• Regulatory Expansion: Potential approvals for earlier-line use or additional indications could significantly increase sales.
• Pipeline Development: Investigational uses in combination regimens or other malignancies may unlock new revenue streams.

Challenges to Growth

• Patent Expiry Risks: The expiration of key patents could lead to generic competition, impacting pricing power.
• Market Saturation: Saturation within resistant CML cases limits growth unless new indications are approved.
• Competitive Innovation: Emergence of next-generation TKIs with improved efficacy and tolerability could threaten Bosulif’s market share.

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Strategic Outlook and Investment Considerations

Given the evolving landscape, Pfizer's strategic focus might involve:

• Investing in Clinical Trials: To demonstrate efficacy in novel indications or earlier lines.
• Pricing Strategies: To maintain profitability amidst payer pressures.
• Partnerships & Collaborations: For combination therapies or new delivery mechanisms.

Investors should monitor:

• Regulatory decisions regarding new indications.
• Clinical trial outcomes for combination or phased studies.
• Competitive developments from rival TKIs or emerging therapies.

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Key Takeaways

• Bosulif’s market is strategically positioned within resistant CML management, with expansion opportunities contingent on regulatory developments and clinical evidence.
• The competitive landscape challenges growth, demanding differentiated positioning and potential label expansions.
• Revenue prospects remain modest in the near term but could improve with broader indications or combination regimens.
• Pfizer's focus on pipeline development and clinical validation remains crucial for Bosulif’s long-term market viability.
• Market dynamics are shaped by innovation, pricing, and physician adoption patterns, necessitating continuous strategic adaptation by stakeholders.

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FAQs

1. What are the primary competitors to Bosulif in the CML market?
The main competitors include imatinib, dasatinib, nilotinib, ponatinib, and asciminib. These agents differ in efficacy, safety profiles, and line-of-therapy positioning, influencing Bosulif’s market share.

2. How do regulatory approvals influence Bosulif's market trajectory?
New approvals, especially for earlier or additional indications, can expand the patient base and drive sales. Conversely, delays or withdrawal of indications can constrain growth.

3. What safety concerns affect Bosulif’s usage?
Adverse events such as diarrhea, hepatotoxicity, and myelosuppression impact prescribing. Clinicians weigh these risks against benefits, especially when safer alternatives are available.

4. Can Bosulif expand into non-CML indications?
Potential exists if clinical trials demonstrate efficacy in other hematologic malignancies or solid tumors. Currently, its development focus remains primarily on CML.

5. How might patent expirations impact Bosulif’s revenue?
Patent expiration could lead to generic competition, reducing pricing power and sales volumes, unless new indications or formulations are developed and approved.

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References

[1] Pfizer. (2012). Bosulif (bosutinib) initial approval announcement.
[2] IQVIA. (2022). Global Oncology Market Data.
[3] FDA. (2017). Bosulif approval expansion for newly diagnosed CML.
[4] National Comprehensive Cancer Network (NCCN). (2023). CML Clinical Practice Guidelines.
[5] EvaluatePharma. (2023). Pharmaceutical Sales Data.