Bosutinib Monohydrate Patent Expiration

Bosutinib Monohydrate is used for treating BCR-ABL positive leukemia resistant to imatinib, including patients with specific BCR-ABL mutations and various phases of CML. It was first introduced by Pf Prism Cv in its drug Bosulif on Sep 4, 2012. 2 different companies have introduced drugs containing Bosutinib Monohydrate.


Bosutinib Monohydrate Patents

Given below is the list of patents protecting Bosutinib Monohydrate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Bosulif US11103497

(Pediatric)

Treatment of imatinib resistant leukemia Aug 28, 2034 Pf Prism Cv
Bosulif US11103497 Treatment of imatinib resistant leukemia Feb 28, 2034 Pf Prism Cv
Bosulif US7767678

(Pediatric)

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 May 23, 2027 Pf Prism Cv
Bosulif US7767678 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 Nov 23, 2026 Pf Prism Cv
Bosulif US7417148

(Pediatric)

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Jun 11, 2026 Pf Prism Cv
Bosulif US7919625

(Pediatric)

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Jun 11, 2026 Pf Prism Cv
Bosulif US7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Dec 11, 2025 Pf Prism Cv
Bosulif US7919625 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Dec 11, 2025 Pf Prism Cv
Bosulif USRE42376

(Pediatric)

Substituted 3-cyanoquinolines Oct 13, 2024

(Expired)

Pf Prism Cv
Bosulif USRE42376 Substituted 3-cyanoquinolines Apr 13, 2024

(Expired)

Pf Prism Cv
Bosulif US6002008 Substituted 3-cyano quinolines Mar 27, 2018

(Expired)

Pf Prism Cv
Bosulif US6002008 Substituted 3-cyano quinolines Mar 27, 2018

(Expired)

Pf Prism Cv



Bosutinib Monohydrate's Family Patents

Family Patents

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Bosutinib Monohydrate Generic API Manufacturers

Several generic applications have been filed for Bosutinib Monohydrate.

Given below is the list of companies who have filed for Bosutinib Monohydrate generic, along with the locations of their manufacturing plants worldwide.


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Bosutinib Monohydrate. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100MG BASE

tablet Prescription ORAL AB May 23, 2025
EQ 500MG BASE

tablet Prescription ORAL AB May 23, 2025


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd
Panelav Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited