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

See all BOSUTINIB MONOHYDRATE clinical trials

Generic filers with tentative approvals for BOSUTINIB MONOHYDRATE

Applicant	Application No.	Strength	Dosage Form
		EQ 100MG BASE	TABLET;ORAL
		EQ 500MG BASE	TABLET;ORAL
		EQ 500MG BASE	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	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes					Y
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	203341-002	Sep 4, 2012	AB	RX	Yes	No					Y

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

International Patents for BOSUTINIB MONOHYDRATE

Country	Patent Number	Title	Estimated Expiration
Slovenia	2478905
Taiwan	200740797	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
Colombia	5690608	4-ANILINO-3-QUINOLINCARBONITRILOS PARA EL TRATAMIENTO DE LEUCEMIA MIELOGENA CRONICA
Portugal	1902029

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: February 20, 2026

Bosutinib Monohydrate is an oral kinase inhibitor approved primarily for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). As a second-generation BCR-ABL inhibitor, it addresses resistance to first-line therapies like imatinib.

Market Overview

Therapeutic Market and Disease Prevalence

CML affects approximately 150,000 patients worldwide, with about 80-90% diagnosed at the chronic phase. The global CML market size was valued at around USD 2.5 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of approximately 7% through 2027[1].

Current Treatment Landscape

First-line therapy deploys BCR-ABL inhibitors like imatinib. Second-generation inhibitors such as dasatinib, nilotinib, and bosutinib are used when patients develop resistance or intolerances. Third-generation drugs like ponatinib target resistant mutations including T315I.

Bosutinib's Market Position

Bosutinib holds a niche in second-line treatment for patients resistant or intolerant to prior therapy, with a market share estimated at 25% among second-line BCR-ABL inhibitors in 2022[2].

Competitor Analysis

Drug	Indication	Market Share (2022)	Approval Date	Unique Features
Imatinib	First-line CML	50%	2001	First tyrosine kinase inhibitor
Dasatinib	Second-line CML	20%	2006	Potent BCR-ABL inhibition
Nilotinib	Second-line CML	15%	2007	Increased potency over imatinib
Bosutinib	Second-line CML	10-15%	2012	Less myelosuppression; fewer drug interactions
Ponatinib	Resistant CML	10%	2012	Targets T315I mutation

Regulatory and Clinical Data

Bosutinib received FDA approval in September 2012 for adults with Ph+ CML. It demonstrated a 43% major molecular response rate at 12 months in clinical trials for resistant patients[3].

Forecasting Financial Trajectory

Revenue Drivers

• Diagnostic market expansion increasing early detection.
• Growing second-line treatment adoption as resistance rates escalate.
• New formulations and combination therapies enhancing patient compliance.

Revenue Projections

Year	Estimated Revenue (USD Billion)	Comments
2023	0.3	Steady penetration in second-line therapy
2025	0.4	Market expansion, increased line-of-therapy use
2027	0.6	Entry into third-line settings, chronic therapy adoption

Cost Considerations

• R&D expenses for combination trials and novel formulations.
• Pricing strategies influenced by competition, patent status, and healthcare reimbursement policies.
• Patent expiration for core formulations around 2029, risking price erosion.

Patent and Regulatory Landscape

Patent life extends to 2029, with orphan drug status in select regions providing exclusivity. Biosimilar or generic versions could enter the market post-2029, impacting revenue.

Market Entry Strategies

Pharmaceutical companies focus on:

• Expanding indications to include frontline and post-transplant settings.
• Developing combination therapies with emerging agents.
• Penetrating emerging markets with increasing CML prevalence.

Key Challenges and Opportunities

Challenges

• Competition from generic versions post-patent expiry.
• Potential side effects leading to treatment discontinuation.
• Slow adoption in regions with limited healthcare infrastructure.

Opportunities

• Clinical trials exploring first-line use.
• Development of fixed-dose combination therapies.
• Strategic alliances for regional expansion.

Key Takeaways

• Bosutinib Monohydrate is a niche second-line CML therapy with steady but limited market share.
• Market growth hinges on extending indications and enhancing formulations.
• Revenue is expected to grow modestly to USD 0.6 billion by 2027, facing imminent patent expiration.
• Competitive threats from generics and emerging therapies will impact long-term profitability.
• Strategic investments in combination therapies and global expansion could mitigate risks.

FAQs

1. When is bosutinib expected to lose patent protection?
   Patent protection is projected to expire around 2029, potentially opening the market to biosimilars or generics.

2. What distinguishes bosutinib from other second-generation BCR-ABL inhibitors?
   It has a distinct safety profile with fewer myelosuppressive effects and fewer drug interactions.

3. Are there plans for bosutinib to be used as a first-line treatment?
   Clinical trials are ongoing; current evidence supports second-line use, pending approval for broader indications.

4. How significant is the resistance development to bosutinib?
   Resistance is less common but can involve mutations in the BCR-ABL kinase domain; third-generation inhibitors address resistant mutations like T315I.

5. What markets present the most growth opportunities for bosutinib?
   Emerging markets in Asia and Latin America, coupled with indication expansion in developed markets, offer growth potential.

References

[1] Global Market Insights. (2022). CML therapeutics market report.
[2] IQVIA. (2022). Market share analysis of BCR-ABL inhibitors.
[3] FDA. (2012). Bosutinib approval documentation.