Abraxane is a drug owned by Bristol-myers Squibb Co. It is protected by 32 US drug patents filed from 2013 to 2019. Out of these, 14 drug patents are active and 18 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 12, 2034. Details of Abraxane's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9511046 (Pediatric) | Methods of treating pancreatic cancer |
Jul, 2034
(9 years from now) | Active |
| US9511046 | Methods of treating pancreatic cancer |
Jan, 2034
(8 years from now) | Active |
|
US9597409 (Pediatric) | Methods of treating cancer |
Sep, 2032
(7 years from now) | Active |
|
US9393318 (Pediatric) | Methods of treating cancer |
Sep, 2032
(7 years from now) | Active |
| US9597409 | Methods of treating cancer |
Mar, 2032
(6 years from now) | Active |
| US9393318 | Methods of treating cancer |
Mar, 2032
(6 years from now) | Active |
|
US8034375 (Pediatric) | Combinations and modes of administration of therapeutic agents and combination therapy |
Feb, 2027
(1 year, 9 months from now) | Active |
|
US8268348 (Pediatric) | Combinations and modes of administration of therapeutic agents and combination therapy |
Aug, 2026
(1 year, 3 months from now) | Active |
|
US7758891 (Pediatric) | Combinations and modes of administration of therapeutic agents and combination therapy |
Aug, 2026
(1 year, 3 months from now) | Active |
|
US9101543 (Pediatric) | Combinations and modes of administration of therapeutic agents and combination therapy |
Aug, 2026
(1 year, 3 months from now) | Active |
| US8034375 | Combinations and modes of administration of therapeutic agents and combination therapy |
Aug, 2026
(1 year, 3 months from now) | Active |
| US8268348 | Combinations and modes of administration of therapeutic agents and combination therapy |
Feb, 2026
(9 months from now) | Active |
| US9101543 | Combinations and modes of administration of therapeutic agents and combination therapy |
Feb, 2026
(9 months from now) | Active |
| US7758891 | Combinations and modes of administration of therapeutic agents and combination therapy |
Feb, 2026
(9 months from now) | Active |
|
US7820788 (Pediatric) | Compositions and methods of delivery of pharmacological agents |
Apr, 2025
(12 days ago) |
Expired
|
| US7820788 | Compositions and methods of delivery of pharmacological agents |
Oct, 2024
(6 months ago) |
Expired
|
|
US7923536 (Pediatric) | Compositions and methods of delivery of pharmacological agents |
Jun, 2024
(10 months ago) |
Expired
|
|
US8314156 (Pediatric) | Compositions and methods of delivery of pharmacological agents |
Jun, 2024
(10 months ago) |
Expired
|
|
US8138229 (Pediatric) | Compositions and methods of delivery of pharmacological agents |
Jun, 2024
(10 months ago) |
Expired
|
| US8314156 | Compositions and methods of delivery of pharmacological agents |
Dec, 2023
(1 year, 4 months ago) |
Expired
|
| US8138229 | Compositions and methods of delivery of pharmacological agents |
Dec, 2023
(1 year, 4 months ago) |
Expired
|
| US7923536 | Compositions and methods of delivery of pharmacological agents |
Dec, 2023
(1 year, 4 months ago) |
Expired
|
|
US8853260 (Pediatric) | Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof |
Apr, 2021
(4 years ago) |
Expired
|
| US8853260 | Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof |
Oct, 2020
(4 years ago) |
Expired
|
| USRE41884 | Reduction of intravenously administered nanoparticulate-formulation-induced adverse physiological reactions |
Aug, 2016
(8 years ago) |
Expired
|
| US5498421 | Composition useful for in vivo delivery of biologics and methods employing same |
Mar, 2013
(12 years ago) |
Expired
|
| US6749868 | Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof |
Feb, 2013
(12 years ago) |
Expired
|
| US5439686 | Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor |
Feb, 2013
(12 years ago) |
Expired
|
| US6096331 | Methods and compositions useful for administration of chemotherapeutic agents |
Feb, 2013
(12 years ago) |
Expired
|
| US6537579 | Compositions and methods for administration of pharmacologically active compounds |
Feb, 2013
(12 years ago) |
Expired
|
| US6506405 | Methods and formulations of cremophor-free taxanes |
Feb, 2013
(12 years ago) |
Expired
|
| US6753006 | Paclitaxel-containing formulations |
Feb, 2013
(12 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 Abraxane's patents.
Latest Legal Activities on Abraxane's Patents
Given below is the list of recent legal activities going on the following patents of Abraxane.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 08 Jul, 2024 | US8314156 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | US9511046 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Mar, 2024 | US8268348 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2024 | US9393318 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Sep, 2023 | US8138229 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Mar, 2023 | US8034375 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jan, 2023 | US9101543 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Sep, 2022 | US7923536 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Apr, 2022 | US7820788 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Mar, 2022 | US8853260 |
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 Abraxane and ongoing litigations to help you estimate the early arrival of Abraxane generic.
Abraxane's Litigations
Abraxane been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 04, 2017, against patent number US8853260. The petitioner Actavis LLC, challenged the validity of this patent, with ABRAXIS BIOSCIENCE, LLC as the respondent. Click below to track the latest information on how companies are challenging Abraxane's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7820788 | November, 2017 |
Terminated-Settled
(13 Jul, 2018) | Abraxis BioScience, LLC | Apotex Inc. |
| US7923536 | November, 2017 |
Terminated-Settled
(13 Jul, 2018) | Abraxis Biosciences, LLC | Apotex Inc. |
| US8138229 | November, 2017 |
Terminated
(13 Jul, 2018) | Abraxis BioScience, LLC et al. | Apotex Inc. et al. |
| US7820788 | April, 2017 |
Terminated-Settled
(08 May, 2018) | ABRAXIS BIOSCIENCE, LLC | Actavis LLC |
| US7820788 | November, 2017 |
Terminated-Denied
(08 May, 2018) | Abraxis Biosciences, LLC | Cipla Ltd. |
| US7923536 | April, 2017 |
Terminated-Settled
(08 May, 2018) | ABRAXIS BIOSCIENCE, LLC | Actavis LLC |
| US7923536 | November, 2017 |
Terminated-Denied
(08 May, 2018) | Abraxis Biosciences, LLC | Cipla Ltd. |
| US8138229 | April, 2017 |
Terminated-Settled
(08 May, 2018) | ABRAXIS BIOSCIENCE, LLC, | Actavis LLC |
| US8138229 | November, 2017 |
Terminated-Denied
(08 May, 2018) | AbraxisBiosciences, LLC | Cipla Ltd. |
| US8853260 | April, 2017 |
Terminated-Denied
(11 Oct, 2017) | ABRAXIS BIOSCIENCE, LLC | Actavis LLC |
FDA has granted some exclusivities to Abraxane. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Abraxane, 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 Abraxane.
Exclusivity Information
Abraxane holds 6 exclusivities. All of its exclusivities have expired in 2023. Details of Abraxane's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-658) | Oct 11, 2015 |
| New Indication(I-676) | Sep 06, 2016 |
| Orphan Drug Exclusivity(ODE) | Sep 06, 2020 |
| Orphan Drug Exclusivity(ODE-52) | Sep 06, 2020 |
| M(M-14) | Dec 06, 2022 |
| Pediatric Exclusivity(PED) | Jun 06, 2023 |
Several oppositions have been filed on Abraxane'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 Abraxane's generic, the next section provides detailed information on ongoing and past EP oppositions related to Abraxane patents.
Abraxane's Oppositions Filed in EPO
Abraxane has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 01, 2012, by Generics [Uk] Limited. This opposition was filed on patent number EP06735710A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP14737791A | Feb, 2022 | Accord Healthcare | Revoked |
| EP14737791A | Feb, 2022 | Teva Pharmaceutical Industries Ltd. | Revoked |
| EP14737791A | Jan, 2022 | Generics [UK] Limited | Revoked |
| EP17165979A | Apr, 2020 | Generics (UK) Ltd | Revoked |
| EP17165979A | Apr, 2020 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP03799876A | Mar, 2019 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP03799876A | Mar, 2019 | Wittkopp, Alexander | Revoked |
| EP11763292A | Jun, 2017 | Generics (UK) Ltd | Revoked |
| EP11763292A | Jun, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP06735710A | Aug, 2012 | MediGene Aktiengesellschaft | Revoked |
| EP06735710A | Aug, 2012 | Generics [UK] Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Abraxane 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 Abraxane's family patents as well as insights into ongoing legal events on those patents.
Abraxane's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Abraxane's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 12, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Abraxane Generic API suppliers:
Paclitaxel is the generic name for the brand Abraxane. 16 different companies have already filed for the generic of Abraxane, with Hospira having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Abraxane's generic
How can I launch a generic of Abraxane before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Abraxane's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Abraxane'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 Abraxane -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg/vial | 11 Dec, 2015 | 1 | 27 Oct, 2024 |
Alternative Brands for Abraxane
Abraxane which is used for treating tumors, breast cancer, lung cancer, and pancreatic cancer., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Ipsen |
| |||
About Abraxane
Abraxane is a drug owned by Bristol-Myers Squibb Co. It is used for treating tumors, breast cancer, lung cancer, and pancreatic cancer. Abraxane uses Paclitaxel as an active ingredient. Abraxane was launched by Bristol-Myers in 2005.
Approval Date:
Abraxane was approved by FDA for market use on 07 January, 2005.
Active Ingredient:
Abraxane uses Paclitaxel as the active ingredient. Check out other Drugs and Companies using Paclitaxel ingredient
Treatment:
Abraxane is used for treating tumors, breast cancer, lung cancer, and pancreatic cancer.
Dosage:
Abraxane is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/VIAL | POWDER | Prescription | INTRAVENOUS |