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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 five 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^® Generic Entry Outlook for Bosulif

Bosulif was eligible for patent challenges on September 4, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 26, 2030. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BOSULIF

International Patents:	81
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	16
Patent Applications:	3,317
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BOSULIF

Constraining patent/regulatory exclusivity:

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY

NDA:

203341

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY

NDA:

217729

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 five US patents and seven FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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		RX	Yes	No					Y
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		RX	Yes	No
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012		RX	Yes	No					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

Australia

Brazil

Canada

China

Costa Rica

Cyprus

Denmark

Ecuador

European Patent Office

Guatemala

Hong Kong

Japan

Mexico

Norway

Panama

Peru

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

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
Cyprus	1124391
World Intellectual Property Organization (WIPO)	2007005462
Mexico	2008000384	FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOX I-7-[3-(4-METIL-1-PIPERAZINIL)PROPOXI]-3-QUINOLINOCARBONITRILO Y METODOS PARA SU PREPARACION. (CRYSTALLINE FORMS OF 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-ME THOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARB-ONIT RILE AND METHODS OF PREPARING THE SAME.)
Argentina	054505	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

BOSULIF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BOSULIF (Bosutinib)

Introduction

BOSULIF (bosutinib) is a tyrosine kinase inhibitor (TKI) developed by Pfizer, approved for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy. Here, we delve into the market dynamics and financial trajectory of BOSULIF.

Market Overview of CML Treatments

The global CML market is characterized by a mix of branded and generic TKIs. In 2020, the 8MM (eight major markets) CML market was valued at $4.25 billion, with expectations of peaking in 2023 before declining at a CAGR of more than -3% through 2030[1].

Key Players and Market Share

Pfizer, along with Novartis and Bristol Myers Squibb, is a significant player in the CML market. Novartis and BMS dominate the market with their second-generation TKIs, Tasigna (nilotinib) and Sprycel (dasatinib), respectively. Pfizer's presence is bolstered by BOSULIF, which targets a specific segment of CML patients who are resistant or intolerant to other TKIs[1].

Approval and Clinical Significance

BOSULIF was approved by the FDA in 2012 for patients with previously treated Ph+ CML. It is notable for being the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second-generation TKI. This approval highlights Pfizer's commitment to advancing cancer drug development and addressing unmet needs in the CML treatment landscape[4].

Target Patient Population

BOSULIF is designed for patients who have not responded well to initial therapies such as imatinib or second-generation TKIs. This niche positioning helps in capturing a specific market segment, particularly those with limited treatment options. The increasing prevalence of CML and the need for effective second-line treatments drive the demand for BOSULIF[4].

Financial Performance

The financial performance of BOSULIF is intertwined with Pfizer's overall oncology portfolio. While specific revenue figures for BOSULIF are not separately disclosed, it contributes to Pfizer's broader hematology and oncology segment. Pfizer's oncology drugs, including BOSULIF, are part of the company's growing pipeline, which is expected to drive future top-line growth[3].

Revenue Impact

Pfizer's revenue from its oncology segment, including BOSULIF, has been significant. However, the company's overall revenue has seen fluctuations, particularly due to the decline in sales of COVID-19 related products like Comirnaty and Paxlovid. Excluding these contributions, Pfizer's revenues from other products, including oncology drugs like BOSULIF, have shown operational growth[5].

Market Growth Drivers

Several factors drive the market growth for BOSULIF:

• Approval and Launch of New Therapeutics: The approval of new agents, including BOSULIF, and the expansion of existing ones into new lines of therapy, contribute to market growth[1].
• Increased Prevalence: The rising number of CML cases, expected to increase significantly by 2040, increases the demand for effective treatments like BOSULIF[4].
• Adoption of Branded TKIs: The preference for branded second and third-generation TKIs over generic imatinib in many markets supports the sales of BOSULIF[1].

Challenges and Inhibitors

Despite these drivers, several challenges affect the financial trajectory of BOSULIF:

• Patent Expiries: The patent expiries of many TKIs, including some of Pfizer's competitors, could lead to increased generic competition and reduce market share for branded drugs like BOSULIF[1].
• Regulatory Pressures: Regulatory changes, such as the Inflation Reduction Act, could impact the pricing and revenue of branded drugs, including BOSULIF[3].

Geographic Market Dynamics

The US is the largest market for CML treatments, accounting for more than 60% of total CML sales in 2020. Pfizer's strong presence in the US market, combined with the slow growth in the 5EU, is expected to increase the US market share by 2030[1].

Expert Insights

"BOSULIF is an important new addition to the CML treatment landscape," said Dr. Jorge E. Cortes, deputy chair and professor of medicine at The University of Texas MD Anderson Cancer Center. "Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors."[4]

Key Takeaways

• Niche Market Positioning: BOSULIF targets a specific segment of CML patients resistant or intolerant to other TKIs.
• Clinical Significance: Approved with pivotal trial data including patients treated with imatinib followed by a second-generation TKI.
• Financial Contribution: Part of Pfizer's growing oncology portfolio, contributing to operational growth excluding COVID-19 related products.
• Market Drivers: Driven by new approvals, increased prevalence, and adoption of branded TKIs.
• Challenges: Faces patent expiries and regulatory pressures.

FAQs

Q: What is BOSULIF used for? A: BOSULIF (bosutinib) is used for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy.

Q: When was BOSULIF approved by the FDA? A: BOSULIF was approved by the FDA in 2012.

Q: What makes BOSULIF unique in the CML treatment landscape? A: BOSULIF is the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second-generation TKI.

Q: How does BOSULIF contribute to Pfizer's revenue? A: BOSULIF contributes to Pfizer's broader hematology and oncology segment, driving operational growth excluding COVID-19 related products.

Q: What are the main challenges facing BOSULIF in the market? A: The main challenges include patent expiries of competing TKIs and regulatory pressures that could impact pricing and revenue.

Sources

1. GlobalData: Chronic Myeloid Leukemia (CML): Global Drug Forecast and Market Analysis.
2. Royalty Pharma: Royalty Pharma Reports First Quarter 2023 Results.
3. University of Iowa: Krause Fund Research - Current Students.
4. Pfizer: U.S. Food and Drug Administration Approves BOSULIF® (bosutinib) for Patients with Previously Treated Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (CML).
5. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance.