Bosulif Patent Expiration

Bosulif is a drug owned by Pf Prism Cv. It is protected by 11 US drug patents filed from 2013 to 2023. Out of these, 9 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 28, 2034. Details of Bosulif's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6002008 Substituted 3-cyano quinolines
Mar, 2018

(6 years ago)

Expired
USRE42376 Substituted 3-cyanoquinolines
Apr, 2024

(3 months ago)

Expired
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, 2026

(2 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6002008 Substituted 3-cyano quinolines
Mar, 2018

(6 years ago)

Expired
USRE42376

(Pediatric)

Substituted 3-cyanoquinolines
Oct, 2024

(2 months from now)

Active
US7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Dec, 2025

(1 year, 4 months from now)

Active
US7919625 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Dec, 2025

(1 year, 4 months from now)

Active
US7919625

(Pediatric)

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Jun, 2026

(1 year, 10 months from now)

Active
US7417148

(Pediatric)

4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Jun, 2026

(1 year, 10 months from now)

Active
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, 2027

(2 years from now)

Active
US11103497 Treatment of imatinib resistant leukemia
Feb, 2034

(9 years from now)

Active
US11103497

(Pediatric)

Treatment of imatinib resistant leukemia
Aug, 2034

(10 years from now)

Active


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Bosulif and ongoing litigations to help you estimate the early arrival of Bosulif generic.

Bosulif's Litigations

Bosulif has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 30, 2019, against patent number US11103497. The petitioner , challenged the validity or infringement of this patent, with Becker Hewes as the respondent. Click below to track the latest information on how companies are challenging Bosulif's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11103497 August, 2019 Decision Becker Hewes


FDA has granted some exclusivities to Bosulif. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bosulif, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Bosulif.

Exclusivity Information

Bosulif holds 8 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Bosulif's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Sep 04, 2017
Orphan Drug Exclusivity(ODE) Sep 04, 2019
Orphan Drug Exclusivity(ODE-30) Sep 04, 2019
New Indication(I-759) Dec 19, 2020
Orphan Drug Exclusivity(ODE-163) Dec 19, 2024
New Indication(I-923) Sep 26, 2026
Pediatric Exclusivity(PED) Mar 26, 2027
Orphan Drug Exclusivity(ODE-444) Sep 26, 2030

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Several oppositions have been filed on Bosulif's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Bosulif's generic, the next section provides detailed information on ongoing and past EP oppositions related to Bosulif patents.

Bosulif's oppositions filed in EPO

Bosulif has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 07, 2014, by Fresenius Kabi Deutschland Gmbh. This opposition was filed on patent number EP06774184A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP15191756A Apr, 2022 SANDOZ AG Granted and Under Opposition
EP12160638A Feb, 2015 Generics (UK) Ltd (trading as Mylan) Opposition rejected
EP06774184A Oct, 2014 Generics [UK] Ltd (trading as Mylan) Patent maintained as amended
EP06774184A Oct, 2014 Fresenius Kabi Deutschland GmbH Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Bosulif is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Bosulif's family patents as well as insights into ongoing legal events on those patents.

Bosulif's family patents

Bosulif has patent protection in a total of 30 countries. It's US patent count contributes only to 15.1% of its total global patent coverage. 13 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Bosulif.

Family Patents

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Generic Launch

Generic Release Date:

Bosulif's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 28, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Bosulif Generics:

There are no approved generic versions for Bosulif as of now.

How can I launch a generic of Bosulif before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Bosulif's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bosulif's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Bosulif -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
100 mg and 500 mg 06 Sep, 2016 2 23 Nov, 2026
400 mg 25 Oct, 2018 1 23 Nov, 2026




About Bosulif

Bosulif is a drug owned by Pf Prism Cv. It is used for treating BCR-ABL positive leukemia resistant to imatinib, including patients with specific BCR-ABL mutations and various phases of CML. Bosulif uses Bosutinib Monohydrate as an active ingredient. Bosulif was launched by Pf Prism Cv in 2012.

Market Authorisation Date:

Bosulif was approved by FDA for market use on 04 September, 2012.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Bosulif is 04 September, 2012, its NCE-1 date is estimated to be 26 March, 2026

Active Ingredient:

Bosulif uses Bosutinib Monohydrate as the active ingredient. Check out other Drugs and Companies using Bosutinib Monohydrate ingredient

Treatment:

Bosulif is used for treating BCR-ABL positive leukemia resistant to imatinib, including patients with specific BCR-ABL mutations and various phases of CML.

Dosage:

Bosulif is available in the following dosage forms - tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 400MG BASE TABLET Prescription ORAL
EQ 100MG BASE TABLET Prescription ORAL
EQ 500MG BASE TABLET Prescription ORAL
EQ 50MG BASE CAPSULE Prescription ORAL