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 one branded drug marketed by Pf Prism Cv and is included in two NDAs. There are five 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.

Summary for BOSUTINIB MONOHYDRATE

International Patents:	81
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	1
Patent Applications:	57
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BOSUTINIB MONOHYDRATE
DailyMed Link:	BOSUTINIB MONOHYDRATE at DailyMed

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

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

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

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 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

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	RE42376*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-001	Sep 26, 2023		RX	Yes	No	7,417,148*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012		RX	Yes	Yes	7,919,625*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-002	Sep 26, 2023		RX	Yes	Yes	7,417,148*PED				Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012		RX	Yes	No	7,767,678*PED				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	6,002,008
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	6,002,008
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017	6,002,008

International Patents for BOSUTINIB MONOHYDRATE

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
Norway	20062255
World Intellectual Property Organization (WIPO)	2005047259

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

BOSUTINIB MONOHYDRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bosutinib Monohydrate

Introduction

Bosutinib monohydrate, marketed under the brand name Bosulif, is a potent dual SRC and ABL tyrosine kinase inhibitor used primarily in the treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Overview

The global market for bosutinib monohydrate is influenced by several key factors, including the prevalence of CML, the efficacy of the drug, regulatory approvals, and competition within the tyrosine kinase inhibitor (TKI) market.

Prevalence of CML

CML is a rare type of cancer that affects the white blood cells and tends to progress slowly over time. The global incidence of CML is relatively low, but the demand for effective treatments is high, especially for patients who are resistant or intolerant to first-line TKIs like imatinib, nilotinib, and dasatinib[4].

Regulatory Approvals

Bosutinib was first approved by the FDA in 2012 for the treatment of adult chronic, accelerated, or blast-phase Ph+ CML with resistance or intolerance to prior therapy. This initial approval set the stage for its market entry and subsequent growth. More recently, on September 26, 2023, the FDA approved bosutinib for the treatment of pediatric CML, expanding its market potential[5].

Market Share and Growth

The European market for bosutinib monohydrate is expected to grow significantly, with a projected compound annual growth rate (CAGR) over the period from 2023 to 2030. This growth is driven by the increasing demand for second-line and third-line treatments for CML patients who do not respond to or are intolerant of other TKIs[1].

Financial Trajectory

Revenue Projections

The revenue generated by bosutinib monohydrate is expected to increase as more patients are diagnosed with CML and as the drug gains wider acceptance as a treatment option. The market valuation for bosutinib monohydrate in Europe, for instance, is anticipated to rise substantially by 2030, reflecting its growing market share and demand[1].

Pricing and Cost

Bosulif is priced competitively within the TKI market. The cost of treatment with bosutinib can be significant, but it is often covered by health insurance and government programs, especially for patients with limited financial resources. The pricing strategy is crucial in balancing profitability with patient access[4].

Competition

The TKI market is highly competitive, with drugs like imatinib, nilotinib, and dasatinib already established. However, bosutinib's ability to inhibit most resistance-conferring BCR-ABL mutations (except V299L and T315I) provides it with a unique selling proposition, making it a viable option for patients who have failed on other TKIs[5].

Clinical and Economic Value

Efficacy and Safety

Bosutinib has demonstrated significant efficacy in clinical trials, particularly in patients who are resistant or intolerant to prior TKI therapy. The drug has shown promising cytogenetic and hematologic response rates, although overall survival benefit has not yet been demonstrated[4].

Cost-Effectiveness

The cost-effectiveness of bosutinib is a critical factor in its market dynamics. While the drug is expensive, its ability to provide an effective treatment option for patients who have limited alternatives can justify the cost. Health economic studies have shown that bosutinib can offer a favorable cost-benefit profile, especially in the long term[4].

Market Trends and Forecast

Emerging Markets

The growth of bosutinib monohydrate in emerging markets is expected to be significant, driven by increasing healthcare spending and better access to advanced treatments. Countries with growing economies and improving healthcare infrastructures are likely to contribute substantially to the global market share of bosutinib[1].

Research and Development

Continuous research and development are crucial for the long-term success of bosutinib. Ongoing and future clinical trials will provide more data on its efficacy and safety, potentially expanding its indications and enhancing its market position. For example, the recent approval for pediatric CML opens up new market opportunities[5].

Regulatory Environment

Approvals and Conditions

Bosutinib's market authorization is subject to conditions, including ongoing safety monitoring and the submission of additional clinical data. Regulatory bodies like Health Canada and the FDA closely monitor the drug's performance to ensure its benefit-risk profile remains favorable[4].

Orphan Drug Designation

Bosutinib has been granted orphan drug designation in several countries, including the US, Japan, and China. This designation provides incentives such as market exclusivity and reduced regulatory fees, which can positively impact its financial trajectory[2].

Patient Access and Affordability

Insurance Coverage

Patient access to bosutinib is often facilitated by insurance coverage. Many health insurance plans, including government programs, cover the cost of bosutinib, making it more affordable for patients who need it[4].

Patient Assistance Programs

Pharmaceutical companies and non-profit organizations offer patient assistance programs to help make bosutinib more accessible to those who cannot afford it. These programs can include discounts, free medication, or other forms of financial assistance[4].

Key Takeaways

• Regulatory Approvals: Bosutinib's approvals, including recent pediatric indications, are crucial for its market growth.
• Market Share: The drug is expected to gain significant market share in the TKI market, especially in Europe.
• Financial Projections: Revenue is anticipated to increase due to growing demand and expanding indications.
• Competition: Bosutinib's unique mechanism of action sets it apart in a competitive market.
• Cost-Effectiveness: The drug offers a favorable cost-benefit profile, particularly for patients with limited treatment options.

FAQs

What is bosutinib monohydrate used for?

Bosutinib monohydrate is used for the treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult and pediatric patients who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy[5].

When was bosutinib first approved?

Bosutinib was first approved by the FDA in 2012 for the treatment of adult chronic, accelerated, or blast-phase Ph+ CML with resistance or intolerance to prior therapy[5].

What are the common side effects of bosutinib?

Common side effects include elevations in liver enzymes (ALT and AST), diarrhea, nausea, and abdominal pain. Most cases of transaminase elevations occur early in treatment[3].

Is bosutinib covered by insurance?

Yes, many health insurance plans, including government programs, cover the cost of bosutinib, making it more affordable for patients who need it[4].

What is the current market valuation for bosutinib monohydrate?

The European market for bosutinib monohydrate was valued at a significant amount in 2023 and is expected to reach a higher value by 2030, driven by a projected CAGR[1].

Sources

1. Market Research Reports: Bosutinib Monohydrate Tablets - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
2. Synapse: Bosutinib Monohydrate - Drug Targets, Indications, Patents.
3. FDA: BOSULIF (bosutinib) tablets Label.
4. Health Canada: Summary Basis of Decision for Bosulif.
5. DrugBank: Bosutinib monohydrate.