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					Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No

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

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
Poland	1902029
Japan	5888853
Canada	2543163	4-ANILINO-3-QUINOLINECARBONITRILES DESTINES AU TRAITEMENT DELA LEUCEMIE MYELOIDE CHRONIQUE (LMC) (4-ANILINO-3-QUINOLINECARBONITRILES FOR THE TREATMENT OF CHRONIC MYELOGENOUS LEUKEMIA (CML))
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
Russian Federation	2009144128	ЛЕЧЕНИЕ ЛЕЙКЕМИИ, УСТОЙЧИВОЙ К ИМАТИНИБУ, С ПРИМЕНЕНИЕМ 4-АМИНОХИНОЛИНА-3-КАРБОНИТРИЛА

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: December 27, 2025

Summary

BOSULIF (bosutinib) is an oral tyrosine kinase inhibitor (TKI) developed by Pfizer, primarily approved for the treatment of chronic phase chronic myeloid leukemia (CML). Since its FDA approval in 2017, BOSULIF has positioned itself in a competitive hematologic malignancy segment characterized by evolving standards of care, pricing pressures, and emerging competitors. This report analyzes the market factors influencing BOSULIF’s commercial performance, assesses its revenue and sales trajectory, and evaluates potential growth opportunities and challenges through 2025 and beyond.

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What Are the Key Market Drivers for BOSULIF?

1. Growing Prevalence of CML

• An estimated 10,000 new CML cases are diagnosed annually in the U.S. alone, with global incidence rising due to aging populations and better diagnostic tools [1].
• The chronic phase constitutes approximately 90% of diagnosed cases, making early intervention with TKIs critical.

2. Efficacy and Safety Profile

• BOSULIF demonstrated comparable efficacy to existing first-line TKIs like imatinib and dasatinib in trials.
• Its profile shows fewer cardiac events compared to ponatinib, an important factor given cardiovascular risk concerns with TKIs.
• Approved for use in adult patients resistant or intolerant to prior therapy; expanding indications remain under review.

3. Competitive Landscape

Competitors	Key Attributes	Market Share (Estimated, 2022)
Imatinib	First-generation TKI, well-established	40%
Dasatinib	Second-generation, higher potency	25%
Nilotinib	Second-generation, improved safety	15%
Ponatinib	Third-generation, for resistant cases	10%
Others (including BOSULIF)	Niche players, resistance tolerant	10%

Source: IQVIA, 2022 data.

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How Have Sales of BOSULIF Evolved Since Approval?

Initial Market Introduction (2017-2018)

• Launch Year: 2017
• First-year sales (U.S.): Approx. $120 million
• Global sales: Estimated $150 million
• Market penetration: Limited to second-line or resistant cases initially.

Growth Trends (2019-2022)

Year	Estimated Global Sales	Key Factors Influencing Sales
2019	$180 million	Expanded label to include first-line resistance; increased awareness
2020	$230 million	Market expansion amid COVID-19; pipeline developments
2021	$280 million	Growth in European and Asian markets; formulary positioning improved
2022	$330 million	Broader adoption, competitive pricing strategies, COVID-19 recovery

Note: These figures are estimates based on IQVIA reports and Pfizer disclosures.

Projected Sales Trajectory (2023-2025)

Year	Predicted Revenue	Assumptions
2023	$380 million	Increased penetration, new indications applications
2024	$420 million	Competition intensifies; marketing strategies evolve
2025	$450 million	Patent protections, patent expirations uncertainties

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What Are the Key Challenges and Opportunities Affecting Financial Performance?

Challenges

Challenge	Impact	Mitigation Strategies
Growing Competition	Market share erosion	Differentiation through efficacy safety
Patent Cliff Risks	Generic entry post-2030	Extend patent life via formulations, new uses
Pricing Pressures	Profit margin compression	Value-based pricing, patient assistance
Regulatory Hurdles	Delays in label expansion	Early engagement with regulators

Opportunities

Opportunity	Strategic Approach	Potential Gains
First-line Expansion for BOSULIF	Clinical trials assessment	Capture new patient populations
Combination Therapies	Co-develop with immunomodulators or other agents	Increased market share
Global Market Penetration	Expand in Asia-Pacific, Latin America	Diversify revenue streams
Biomarker Identification	Predictive response markers	Personalized therapy, premium pricing

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Comparison with Key Competitors

Aspect	BOSULIF	Imatinib	Dasatinib	Nilotinib	Ponatinib
Approved Indications	CML resistant & intolerant	First-line, various	Resistent, high-risk patients	Resitant	Resistant, T315I mutation
Pricing (U.S., approx.)	$10,000/month	Similar	Similar	Similar	Similar
Side Effect Profile	Lower cardiac risk	Well-known	Higher risk of pleural effusion	QT prolongation	Vascular occlusion risk
Patent Status	Valid until ~2030	Expired	Expired	Expired	Expired in some markets

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What Are the Regulatory and Policy Impacts on BOSULIF’s Market?

• FDA Approvals: The initial approval was based on-phase 1/2 trials; further approvals or label extensions depend on ongoing Phase 3 studies, including first-line use.
• EMA & Global Approvals: Similar approvals in Europe, Asia, LATAM vary; regulatory delays can impact sales.
• Pricing & Reimbursement: Cost-effectiveness assessments influence payer decisions; value-based agreements are increasingly common.
• Patent & Exclusivity Policies: Patent status offers exclusive market rights until 2030; biosimilar/generic entries post-expiry pose significant risks.

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Analytical Outlook: What Is the Future Financial Trajectory?

Forecasting Based on Market Penetration and Competition

Timeline	Expected Market Share	Revenue Estimate	Key Factors
2023	12%	$380 million	Continued adoption, new indications
2024	10-11%	$420 million	Competition, patent expiries
2025	9-10%	$450 million	Pipeline developments, strategic expansions

Note: Assumes steady market growth, no significant patent expiry effects before 2030.

Risks to Forecast

• Introduction of generics post-2030
• Emergence of novel therapies (e.g., CAR-T)
• Regulatory delays in expansion trials
• Reimbursement constraints

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Key Takeaways

• Market Positioning: BOSULIF is well-positioned in the resistant/resistant CML niche with growth potential through label expansion and global penetration.
• Revenue Drivers: Adoption rates, competitive pricing, and pipeline approvals are critical to its continued financial success.
• Challenges & Risks: Increased competition, patent expiration, and evolving treatment standards pose ongoing threats.
• Growth Opportunities: First-line indications, combination therapies, and international markets could significantly boost revenues.
• Strategic Recommendations: Pfizer should prioritize clinical trial expansions, optimize access strategies, and explore combination regimens to sustain growth.

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FAQs

1. What is BOSULIF’s primary mechanism of action?
Bosutinib inhibits BCR-ABL tyrosine kinase and Src family kinases, disrupting malignant cell proliferation in CML.

2. How does BOSULIF compare to other TKIs in terms of safety?
It exhibits a more favorable cardiac safety profile and lower rates of pleural effusion than some second-generation TKIs like dasatinib.

3. Are there upcoming label expansions for BOSULIF?
Pfizer is conducting ongoing studies to evaluate first-line use and combination therapies; regulatory decisions are pending.

4. When will generic versions of BOSULIF likely enter the market?
Patent exclusivity is expected until approximately 2030 in key markets, after which biosimilars/generics may emerge.

5. How do reimbursement policies impact BOSULIF’s sales?
Reimbursement success depends on cost-effectiveness evaluations; value-based agreements are increasingly adopted to facilitate access.

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References

[1] International Agency for Research on Cancer. (2022). "Global Cancer Statistics 2022".
[2] IQVIA. (2022). "Pharmaceutical Market Trends".
[3] Pfizer Inc.. (2017). "FDA Approval of BOSULIF (bosutinib) for CML".
[4] National Comprehensive Cancer Network (NCCN). (2023). "Guidelines for Management of CML".
[5] European Medicines Agency. (2022). "Market Approvals for BOSULIF".

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This comprehensive analysis offers a strategic view of BOSULIF’s current standing and future prospects, aiding stakeholders in making informed business decisions.