BOSULIF Drug Patent Profile

Name: BOSULIF Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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. Five 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.

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Questions you can ask:

What is the 5 year forecast for BOSULIF?
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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:	6,578
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

Drug patent expirations by year 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.

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Glossary

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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	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-001	Sep 26, 2023		RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BOSULIF

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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	⤷ Start Trial	⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	⤷ Start Trial	⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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:

Norway

Patent: 080051
Estimated Expiration: ⤷ Start Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2008260070		⤷ Start Trial
Brazil	PI0812355		⤷ Start Trial
Canada	2688467		⤷ Start Trial
Canada	2868899		⤷ Start Trial
Canada	2964162		⤷ Start Trial
Chile	2008001577		⤷ Start Trial
China	101686973		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BOSULIF

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1902029	C20140016 00110	Estonia	⤷ Start Trial	PRODUCT NAME: BOSUTINIIB;REG NO/DATE: K(2013)1968 (LOPLIK) 02.04.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

DrugChatter Q&A for BOSULIF

Bosulif generic release date?
Patent of bosulif bosutinib?
Bosulif loss of exclusivity eu?
When is bosulif patent expired?
Is bosulif generic name list?