BOSUTINIB MONOHYDRATE - Generic Drug Details

What are the generic drug sources for bosutinib monohydrate and what is the scope of freedom to operate?

Bosutinib monohydrate is the generic ingredient in two branded drugs marketed by Pf Prism Cv and Alembic, and is included in three NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bosutinib monohydrate has eighty-one patent family members in thirty countries.

There is one drug master file entry for bosutinib monohydrate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BOSUTINIB MONOHYDRATE

International Patents:	81
US Patents:	4
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BOSUTINIB MONOHYDRATE
DailyMed Link:	BOSUTINIB MONOHYDRATE at DailyMed

Recent Clinical Trials for BOSUTINIB MONOHYDRATE

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1

See all BOSUTINIB MONOHYDRATE clinical trials

Generic filers with tentative approvals for BOSUTINIB MONOHYDRATE

Applicant	Application No.	Strength	Dosage Form
		EQ 500MG BASE	TABLET;FILM COATED
		EQ 100MG BASE	TABLET;FILM COATED
		400MG	TABLET;FILM COATED

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BOSUTINIB MONOHYDRATE

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

Anatomical Therapeutic Chemical (ATC) Classes for BOSUTINIB MONOHYDRATE

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BOSUTINIB MONOHYDRATE

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 BOSUTINIB MONOHYDRATE

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	CAPSULE;ORAL	217729-002	Sep 26, 2023		RX	Yes	Yes
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-002	Sep 26, 2023		RX	Yes	Yes
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-002	Sep 26, 2023		RX	Yes	Yes	7,767,678*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	AB	RX	Yes	No

Expired US Patents for BOSUTINIB MONOHYDRATE

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 BOSUTINIB MONOHYDRATE

Country	Patent Number	Title	Estimated Expiration
Japan	2007533655
Costa Rica	8350	4-ANILINO-3-QUINOLINCARBONITRILOS PARA EL TRATAMIENTO DE LEUCEMIA MIELOGENICA CRONICA
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))
Cyprus	1124391
South Africa	200603596	4-Anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
European Patent Office	3002009

Supplementary Protection Certificates for BOSUTINIB MONOHYDRATE

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 BOSUTINIB MONOHYDRATE

Last updated: July 27, 2025

Introduction

Bosutinib Monohydrate, a potent tyrosine kinase inhibitor, marks a significant stride in targeted cancer therapy, specifically for Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). As a second-generation agent designed to overcome resistance to earlier therapies such as imatinib, bosutinib's market potential is shaped by evolving clinical data, regulatory pathways, and competitive landscape. This analysis explores the market dynamics and financial trajectory of bosutinib monohydrate from a strategic perspective, considering pipeline developments, regulatory milestones, and industry trends shaping its commercial outlook.

Pharmacological Profile and Clinical Background

Bosutinib, developed by Pfizer, received FDA approval in 2012 for adult patients with Ph+ CML resistant or intolerant to prior therapy, notably imatinib [1]. It inhibits BCR-ABL and SRC kinase pathways, providing a comprehensive mechanism to combat resistant CML strains. Its safety profile, characterized by manageable side effects, has bolstered its clinical acceptance. Continued research supports its efficacy in first-line treatment, although regulatory approvals in broader indications remain under review, impacting long-term market expansion prospects.

Market Drivers

Growth of Targeted Oncology and Precision Medicine

The increasing adoption of targeted therapies in oncology, driven by improved diagnostics and genetic profiling, fuels demand for kinase inhibitors like bosutinib [2]. The global CML market is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% through 2028, driven by increased diagnosis rates and expanding indications.

Unmet Medical Needs and Resistance Management

Resistance to first-generation TKIs remains a significant challenge in CML management. Bosutinib’s efficacy in resistant cases positions it as a critical line of therapy, particularly for patients who fail or tolerate existing treatments such as imatinib and dasatinib [3]. Its potential utility in earlier lines of therapy fosters additional market penetration.

Regulatory and Patent Dynamics

Regulatory approvals in multiple jurisdictions and potential expansion into first-line therapy augment its market viability. Patent protections, expected to extend into the late 2020s, underpin revenue stability while generic competition looms post-expiration, potentially impacting profit margins.

Market Challenges

Competitive Landscape

Bosutinib faces stiff competition from established therapies—imatinib, dasatinib, nilotinib—as well as emerging agents and third-generation TKIs like ponatinib [4]. Market share shifts depend on comparative efficacy, safety profiles, and pricing strategies.

Pricing and Reimbursement

Pricing strategies significantly influence market access. As healthcare systems worldwide implement cost-containment measures, securing favorable reimbursement and demonstrating cost-effectiveness become critical for commercial success [5].

Pipeline and Off-Label Use

Potential off-label applications or investigational uses in other malignancies could diversify revenue streams but may also introduce regulatory hurdles. The ongoing clinical trials expand bosutinib’s therapeutic scope but require significant investment and pose commercialization risks if outcomes are unfavorable.

Financial Trajectory Outlook

Revenue Projections and Market Share

Pfizer’s sales from bosutinib peaked around $275 million in 2018 and then stabilized, with estimates projecting modest growth contingent upon regulatory expansion and market penetration strategies [6]. Assuming regulatory approvals for first-line use and broader indications, revenue could approach $600-800 million in the next five years.

Impact of Patent Expiration

Patent expiry slated for around 2027-2028 portends increased generic competition, potentially eroding revenue by up to 70% absent differentiation or new indications. Companies may counteract by developing next-generation formulations or combo therapies.

Research & Development Impact

Investment in clinical trials targeting residual resistance mechanisms or combination regimens could open new revenue streams. Successful positioning within personalized medicine paradigms may sustain profitability despite generic threats.

Geographical Expansion

Emerging markets offer substantial growth opportunities, with increasing healthcare infrastructure and diagnosis rates. Tailored pricing and partnership models will influence financial outcomes in these regions.

Strategic Considerations

• Diversification through Combination Therapies: Developing bosutinib as part of combination regimens could enhance efficacy and market positioning.
• Lifecycle Management: Implementation of formulation innovations, such as once-daily dosing or fixed-dose combinations, can extend product relevance.
• Regulatory Engagement: Active pursuit of approvals in additional indications (e.g., acute lymphoblastic leukemia) can diversify revenue.

Conclusion

Bosutinib monohydrate's market dynamics hinge on its clinical utility against resistant CML, competitive forces within the TKIs landscape, and strategic regulatory and commercial moves. While current revenues are moderate, prospects for growth depend on expanding indications, geographical reach, and navigating patent timing. The competitive landscape and patent expirations necessitate proactive lifecycle management to sustain profitability.

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Key Takeaways

• Market Potential: The rising prevalence of CML and resistance to first-line therapies position bosutinib as vital within targeted oncology, with potential for expansion into earlier stages of therapy.
• Competitive Positioning: Ongoing competition from other TKIs underscores the importance of demonstrating superior safety and efficacy to capture market share.
• Revenue Risks: Patent expiry and generic entry signify revenue decline risks post-2027, compelling Pfizer to innovate broadly.
• Strategic Opportunities: Diversification through combination therapies, clinical trial advancements, and regional expansion are critical to maintain financial growth.
• Regulatory Trajectory: Successful approvals in new indications and regions will substantially influence future revenues and market stability.

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FAQs

1. What is the therapeutic profile of bosutinib?
Bosutinib is a second-generation tyrosine kinase inhibitor targeting BCR-ABL and SRC kinases, primarily used for treating Philadelphia chromosome-positive chronic myeloid leukemia resistant to prior therapies.

2. How does bosutinib compare to other TKIs in terms of efficacy?
Clinical trials demonstrate comparable or superior efficacy in resistant cases relative to earlier TKIs, with a favorable safety profile that supports its use in specific patient populations.

3. What are the primary factors affecting bosutinib’s market growth?
Market growth is influenced by regulatory approvals for broader indications, competition from newer TKIs, patent expirations, pricing strategies, and geographic expansion efforts.

4. When will patent expiry impact bosutinib’s revenue?
Patent protection is expected to expire around 2027-2028, after which generic competition could significantly reduce revenues.

5. What strategies can ensure bosutinib’s long-term commercial success?
Investing in new indications, developing combination therapies, optimizing formulations, and expanding into emerging markets are vital strategies to sustain demand.

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References

1. FDA. (2012). Bosutinib (Bosulif) Highlights of Prescribing Information.
2. MarketWatch. (2022). Global Oncology Market Size & Share.
3. ClinicalTrials.gov. (2023). Bosutinib Trials for CML.
4. PharmaLive. (2021). Competitive Landscape of TKIs in CML.
5. IQVIA. (2022). Healthcare Reimbursement and Pricing Trends.
6. Pfizer. (2018). Bosutinib Sales Report.