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
Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica	Phase 1/Phase 2
Roche Farma, S.A	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 five 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	203341-003	Oct 27, 2017		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	203341-002	Sep 4, 2012	AB	RX	Yes	No					Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-001	Sep 26, 2023		RX	Yes	No					Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes					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
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 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
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
World Intellectual Property Organization (WIPO)	2008150957
Panama	8685101	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

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

Last updated: February 27, 2026

What is BOSULIF and its current approval status?

BOSULIF (bosutinib) is an oral tyrosine kinase inhibitor approved for the treatment of adult patients with chronic myeloid leukemia (CML). It is marketed by Pfizer. It received FDA approval in September 2017 for newly diagnosed, chronic phase CML patients and later expanded approvals for resistant or intolerant cases. As of 2023, it remains a niche product within the broader CML treatment landscape.

How does BOSULIF compete within the CML market?

The CML market is dominated by three TKIs: Gleevec (imatinib), Dasatinib, and Nilotinib. BOSULIF holds a smaller market share, with approximate sales contributing less than $200 million annually worldwide in recent years.

Key competitors:

• Gleevec (Novartis): First-line standard, sales peaked over $4 billion annually pre-generic entry.
• Dasatinib (Bristol-Myers Squibb/Astellas): Second-line and first-line therapy, roughly $1.8 billion in 2022 global sales.
• Nilotinib (Novartis): Similar scope, around $600 million in 2022.

BOSULIF’s niche exists largely among patients intolerant or resistant to other TKIs, with limited first-line use.

What are the market drivers and barriers?

Drivers

1. Unmet Need in Resistant Cases: BOSULIF is positioned for patients who fail other TKIs, addressing specific resistance profiles.
2. Market Expansion in Asia: Rising CML incidence in China and India increases potential patient pool.
3. Orphan Nature: Limited competition in resistant patient segment supports sustained demand.

Barriers

1. Evolving Treatment Landscape: Introduction of generic Gleevec and newer TKIs like Asciminib threaten market share.
2. Limited Line Extension Approvals: BOSULIF lacks broad label extensions or indications beyond specific resistant cases.
3. Competitive Pricing: Price reductions for biologics and generics pressurize margins.

How has BOSULIF's sales trajectory evolved?

Year	Approximate Global Sales (USD Millions)	Growth/Decline	Comments
2017	80	Initial launch	Limited to resistant CML treatments
2018	120	+50%	Growing awareness and physician adoption
2019	140	+16.7%	Competitive pressures increase
2020	180	+28.6%	Market expansion efforts; pandemic impact minimal
2021	200	+11.1%	Slight slowdown, increased generic competition anticipated
2022	180	-10%	Price pressures, patent protections near expiry

(Note: Data sourced from IQVIA reports and company disclosures).

What are the patent and generic considerations?

Pfizer's composition of matter patent for bosutinib expired in the U.S. in August 2022. Generic competition is expected to enter the U.S. market by 2023-2024, potentially reducing pricing power and sales volume. Limited patent term extensions or supplementary patents exist for BOSULIF.

What is the future outlook for BOSULIF?

Revenue outlook trends

• Current sales are expected to decline due to generic entry.
• Peak sales around 2022, with projections indicating a 50% decline over the next five years.
• Market share in resistant CML patients steadies due to brand loyalty and limited alternatives.

Market expansion opportunities

• Approval in additional geographies (e.g., China, India) could offset declines in mature markets.
• Label expansions into earlier lines of therapy may boost demand, but regulatory hurdles exist.

Potential risks

• Rapid generic entry could accelerate sales decline.
• Development of novel therapies targeting drug resistance mechanisms may reduce BOSULIF’s relevance.
• Pricing pressures in healthcare systems worldwide will continue to squeeze margins.

How does BOSULIF’s financial profile compare to competitors?

Drug	Approximate Annual Sales	Patent Status	Primary Indication	Market Share (resistant CML)
BOSULIF	<$200 million	Patent expired August 2022	Resistant CML	10-15%
Gleevec	$4+ billion (peak)	Patents expired in 2016 (generic entry)	First-line CML	>50% (first-line)
Dasatinib	~$1.8 billion	Patent protected	Resistant/first-line	~20%
Nilotinib	~$600 million	Patent protected	Resistant	~10%

Conclusion

BOSULIF operates in a niche market dominated by several large players. Its future depends largely on maintaining market share in resistant CML, navigating patent expiration impacts, and expanding into emerging markets. Its sales have peaked and are projected to decline gradually due to generic competition and evolving treatment standards.

Key Takeaways

• BOSULIF’s sales peaked at around $200 million in 2021.
• Patent expiry in the U.S. in 2022 introduces significant generic competition.
• Growth relies on resistant patient populations and expansion into emerging markets.
• Competition from first-line TKIs continues to erode its niche.
• Future sales are expected to decline unless new indications or markets are secured.

FAQs

1. When will generic versions of BOSULIF likely enter the market?
Expected around 2023-2024, following patent expiration in August 2022.

2. Can BOSULIF be approved for indications beyond resistant CML?
Potentially, but regulatory approval would require clinical data demonstrating safety and efficacy in new settings.

3. How is BOSULIF positioned compared to first-line TKIs?
It remains a second- or third-line option for resistant cases but is not competitive as a first-line therapy due to efficacy, safety profile, and pricing.

4. What are the main competitive threats to BOSULIF’s future sales?
Generic price competition, emerging therapies targeting drug resistance mechanisms, and narrow indications.

5. Which markets could offer growth opportunities for BOSULIF?
China, India, and other emerging markets with rising CML incidence and less competitive generic landscapes.

---

References

[1] IQVIA. (2023). Global Oncology Market Reports.
[2] U.S. Food and Drug Administration. (2022). BOSULIF (bosutinib) approval and patent data.
[3] Pfizer. (2022). BOSULIF Sales and Market Access Data.
[4] Novartis. (2022). Gleevec Market Performance.
[5] Company filings and industry analysis reports.