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, 8 drug patents are active and 3 have expired. Bosulif's patents will be open to challenges from 26 March, 2026. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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
(1 year, 6 months from now) | Active |
| USRE42376 | Substituted 3-cyanoquinolines |
Apr, 2024
(1 year, 26 days ago) |
Expired
|
| US6002008 | Substituted 3-cyano quinolines |
Mar, 2018
(7 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US11103497 (Pediatric) | Treatment of imatinib resistant leukemia |
Aug, 2034
(9 years from now) | Active |
| US11103497 | Treatment of imatinib resistant leukemia |
Feb, 2034
(8 years 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 |
|
US7417148 (Pediatric) | 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) |
Jun, 2026
(1 year, 1 month from now) | Active |
|
US7919625 (Pediatric) | 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) |
Jun, 2026
(1 year, 1 month from now) | Active |
| US7417148 | 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) |
Dec, 2025
(7 months from now) | Active |
| US7919625 | 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) |
Dec, 2025
(7 months from now) | Active |
|
USRE42376 (Pediatric) | Substituted 3-cyanoquinolines |
Oct, 2024
(6 months ago) |
Expired
|
| US6002008 | Substituted 3-cyano quinolines |
Mar, 2018
(7 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Bosulif's patents.
Latest Legal Activities on Bosulif's Patents
Given below is the list of recent legal activities going on the following patents of Bosulif.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Sep, 2022 | US7919625 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jan, 2022 | US7767678 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 31 Aug, 2021 | US11103497 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Aug, 2021 | US11103497 |
| Email Notification Critical | 12 Aug, 2021 | US11103497 |
| Issue Notification Mailed Critical | 11 Aug, 2021 | US11103497 |
| Dispatch to FDC | 05 Aug, 2021 | US11103497 |
| Application Is Considered Ready for Issue Critical | 05 Aug, 2021 | US11103497 |
| Issue Fee Payment Verified Critical | 04 Aug, 2021 | US11103497 |
| Issue Fee Payment Received Critical | 04 Aug, 2021 | US11103497 |
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 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 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 |
|---|---|---|---|---|
 | ||||
| US11103497 | August, 2019 |
Decision
(27 Oct, 2020) | 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 9 exclusivities out of which 5 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 |
| New Product(NP) | Sep 26, 2026 |
| Pediatric Exclusivity(PED) | Mar 26, 2027 |
| Orphan Drug Exclusivity(ODE-444) | Sep 26, 2030 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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.
Approval Date:
Bosulif was approved by FDA for market use on 04 September, 2012.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 - capsule form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 50MG BASE | CAPSULE | Prescription | ORAL |
| EQ 400MG BASE | TABLET | Prescription | ORAL |
| EQ 500MG BASE | TABLET | Prescription | ORAL |