BOSULIF Drug Patent Profile

Which patents cover Bosulif, and when can generic versions of Bosulif launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BOSULIF

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	11,103,497*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	AB	RX	Yes	No	7,417,148*PED				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	11,103,497*PED				Y

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
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))
Denmark	3002009
European Patent Office	2777704
Chile	2008001577
Japan	2016074700	４−アミノキノリン−３−カルボニトリルを使用するイマチニブ耐性白血病の処置 (TREATMENT OF IMATINIB RESISTANT LEUKEMIA USING 4-AMINOQUINOLINE-3-CARBONITRILES)

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

Investment Scenario and Fundamentals Analysis for BOSULIF (Bosutinib)

Last updated: February 19, 2026

What is BOSULIF and its Market Position?

BOSULIF (bosutinib) is an oral tyrosine kinase inhibitor approved by the FDA in September 2017 for treating adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapies. Developed by Pfizer, BOSULIF targets BCR-ABL kinase activity, a hallmark of CML. Its global sales represent a significant segment within Pfizer’s oncology portfolio.

Financial Performance and Revenue Trends

Since launch, BOSULIF has posted gradual revenue growth but remains a niche product relative to frontline treatments like imatinib and newer agents such as ponatinib. Pfizer reported:

• 2022 sales: approx. $600 million globally.
• Annual growth rate: about 8%, driven by increased adoption in second-line and resistant cases.
• Market share: Estimated 12–15% in the second-line CML therapy segment (market size approximately $4 billion globally).

Competitors include Novartis (Tasigna), Incyte (ruxolitinib), and Arena Pharmaceuticals (omenaqualis), with BOSULIF maintaining a competitive advantage due to its efficacy and safety profile.

Market Expansion Potential

While BOSULIF's core market is resistant or intolerant CML patients, pipeline and off-label uses may influence future growth:

• Combination therapies: Ongoing investigations for BOSULIF combined with other agents.
• Expanding indications: Potential off-label use in other BCR-ABL-driven malignancies.
• Geographic expansion: Licensing and patent protections support growth in emerging markets, though pricing and reimbursement dynamics vary.

Pfizer’s strategic focus centers on consolidating BOSULIF’s market share through clinical evidence and partnerships.

Patent Landscape and Intellectual Property

BOSULIF’s primary patent protection extends to 2027 in major markets, with secondary patents filed covering formulation and delivery methods to extend exclusivity until 2030. Patent challenges include:

• Legal threats: Generic versions threaten market sharing post-2027.
• Patent filing quality: Strong initial patent drafting underpins exclusivity.

Patent expiry risks could lead to market erosion unless Pfizer or its partners innovate or extend protection.

R&D and Pipeline Outlook

Pfizer continues to explore BOSULIF's role:

• Combination trials: BOSULIF combined with immunotherapies and other targeted agents.
• Next-generation inhibitors: Development of BOSULIF derivatives with improved potency or safety.
• Biomarker research: Identifying patient subgroups most responsive to therapy.

Positive trial outcomes could bolster long-term demand and justify further investment.

Regulatory and Reimbursement Environment

BOSULIF benefits from favorable efficacy data and established safety profile, supporting positive formulary decisions in multiple countries. Reimbursement is generally in line with other targeted therapies, with pricing in the $8,000–$12,000 per treatment course, depending on region.

Regulatory risk includes potential approval delays or label modifications, especially if new comparative trials reveal safety concerns or efficacy gaps.

Competitive Analysis

Drug	Market Share	Indications	Strengths	Limitations
BOSULIF	12–15%	Second-line CML	Oral administration, favorable safety profile	Limited to resistant or intolerant cases
Tasigna (Novartis)	45%	First-line and second-line CML	Broader first-line approval, larger market	Higher toxicity profile
Iclusig (Takeda)	5–7%	Resistant CML, Ph+ ALL	Potent activity in resistant cases	Serious side effects, including vascular events

Risks and Challenges

• Patent expiration: Loss of exclusivity after 2027 may trigger generic entry.
• Market competition: Newer TKIs and combination therapies could erode market share.
• Regulatory hurdles: Additional approvals or restrictions may impact sales.
• Pipeline dependency: Future revenue hinges on pipeline success and off-label adoption.

Summary and Investment Outlook

BOSULIF remains a niche but profitable segment of Pfizer’s oncology portfolio. Its growth trajectory depends on patent protection, clinical development, and competitive dynamics. The core addressable market remains stable but limited, with upside potential from pipeline expansion and geographic growth. Anticipated patent expirations in 2027 represent a key milestone, after which generic competition may impact revenues unless Pfizer secures new IP rights or advances alternative formulations.

---

Key Takeaways

• BOSULIF’s 2022 sales approximate $600 million, with steady growth driven by its role in treatment-resistant CML.
• Patent protections extend until 2027; post-expiry, market erosion risk increases.
• Pfizer’s pipeline includes combination trials and derivative compounds to extend lifecycle.
• Competition from Tasigna and emerging TKIs limits market share but BOSULIF maintains a niche advantage.
• Regulatory and reimbursement environments are stable in high-income markets but more complex in emerging regions.

---

FAQs

1. What factors most influence BOSULIF’s revenue growth?
Patent protection, clinical trial results supporting new indications, and geographic expansion are primary factors.

2. How does BOSULIF compare to other TKIs in efficacy?
It provides comparable efficacy to first- and second-generation TKIs in resistant cases but has a better safety profile than some alternatives.

3. What are the primary patent risks for BOSULIF?
Patent expiry in 2027 poses the greatest threat; secondary patents may provide temporary extension.

4. What clinical developments could significantly impact BOSULIF’s value?
Positive results from combination therapies, new indication approvals, or bioequivalence with generics could reshape its market.

5. How does market competition influence BOSULIF’s long-term prospects?
Newer agents and generics will challenge its market share post-2027 unless innovation or strategic licensing extends exclusivity.

---

References

1. Pfizer Inc. (2022). Annual Report.
2. U.S. Food and Drug Administration. (2017). BOSULIF approval notice.
3. MarketResearch.com. (2023). Global CML therapeutics market report.
4. patent filings and legal analyses, 2023.
5. FDA and EMA drug labels and approval documents.

[1] Pfizer Inc. (2022). Annual report.