Copaxone is a drug owned by Teva Pharmaceuticals Usa. It is protected by 13 US drug patents filed from 2013 to 2016. Out of these, 5 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 19, 2030. Details of Copaxone'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. | |||
| US6054430 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US7199098 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US6362161 | Copolymer-1 improvements on compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US8367605 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9402874 | Low frequency glatiramer acetate therapy |
Aug, 2030
(5 years from now) | Active |
| US9155776 | Low frequency glatiramer acetate therapy |
Aug, 2030
(5 years from now) | Active |
| US8232250 | Low frequency glatiramer acetate therapy |
Aug, 2030
(5 years from now) | Active |
| US8399413 | Low frequency glatiramer acetate therapy |
Aug, 2030
(5 years from now) | Active |
| US8969302 | Low frequency glatiramer acetate therapy |
Aug, 2030
(5 years from now) | Active |
| US6362161 | Copolymer-1 improvements on compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US6620847 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US6939539 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US7199098 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US6054430 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US6342476 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US8367605 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 years ago) |
Expired
|
| US5981589 | Copolymer-1 improvements in compositions of copolymers |
May, 2014
(10 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 Copaxone's patents.
Latest Legal Activities on Copaxone's Patents
Given below is the list of recent legal activities going on the following patents of Copaxone.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Jan, 2024 | US9402874 |
| Expire Patent Critical | 10 Apr, 2023 | US8969302 |
| Case Docketed to Examiner in GAU Critical | 18 May, 2021 | US8232250 |
| Case Docketed to Examiner in GAU Critical | 18 May, 2021 | US8399413 |
| Case Docketed to Examiner in GAU Critical | 18 May, 2021 | US8969302 |
| Maintenance Fee Reminder Mailed Critical | 09 Nov, 2020 | US8399413 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Jul, 2020 | US8367605 |
| Maintenance Fee Reminder Mailed Critical | 23 Mar, 2020 | US8232250 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jan, 2020 | US9402874 |
| Expire Patent Critical | 18 Nov, 2019 | US9155776 |
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 Copaxone and ongoing litigations to help you estimate the early arrival of Copaxone generic.
Copaxone's Litigations
Copaxone been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 16, 2016, against patent number US9155776. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Yeda Research and Development Co. Ltd. as the respondent. Click below to track the latest information on how companies are challenging Copaxone's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9155776 | November, 2016 |
Terminated
(02 May, 2017) | Yeda Research & Development Co., Ltd. et al. | Mylan Pharmaceuticals Inc. et al. |
| US9155776 | July, 2016 |
Terminated
(13 Oct, 2016) | YEDA RESEARCH & DEVELOPMENT CO., LTD. | Amneal Pharmaceuticals LLC et al. |
| US8969302 | March, 2015 |
FWD Entered
(01 Sep, 2016) | Yeda Research & Development Co., Ltd. | Mylan Pharmaceuticals Inc. |
| US8969302 | September, 2015 |
FWD Entered
(01 Sep, 2016) | YEDA RESEARCH & DEVELOPMENT CO. LTD. | Amneal Pharmaceuticals LLC |
| US8232250 | February, 2015 |
FWD Entered
(24 Aug, 2016) | Yeda Research and Development Co. Ltd. | Mylan Pharmaceuticals Inc. |
| US8232250 | September, 2015 |
Final Written Decision
(24 Aug, 2016) | Yeda Research & Development Co., Ltd. et al. | Amneal Pharmaceuticals LLC |
| US8399413 | February, 2015 |
FWD Entered
(24 Aug, 2016) | Yeda Research and Development Co. Ltd. | Mylan Pharmaceuticals Inc. |
| US8399413 | September, 2015 |
FWD Entered
(24 Aug, 2016) | YEDA RESEARCH & DEVELOPMENT CO. LTD. | Amneal Pharmaceuticals LLC |
| US9155776 | February, 2016 |
Terminated-Denied
(15 Aug, 2016) | Yeda Research and Development Co. Ltd. | Mylan Pharmaceuticals Inc. |
FDA has granted some exclusivities to Copaxone. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Copaxone, 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 Copaxone.
Exclusivity Information
Copaxone holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Copaxone's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-594) | Feb 27, 2012 |
| New Product(NP) | Jan 28, 2017 |
US patents provide insights into the exclusivity only within the United States, but Copaxone 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 Copaxone's family patents as well as insights into ongoing legal events on those patents.
Copaxone's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Copaxone's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 19, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Copaxone Generic API suppliers:
Glatiramer Acetate is the generic name for the brand Copaxone. 3 different companies have already filed for the generic of Copaxone, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Copaxone's generic
How can I launch a generic of Copaxone before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Copaxone's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Copaxone'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 Copaxone -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg/mL, 1mL pre- filled syringe | 27 Dec, 2007 | 1 | 16 Apr, 2015 | 24 May, 2014 | Extinguished |
| 40 mg/mL, 1 mL pre- filled syringe | 26 Feb, 2014 | 2 | 03 Oct, 2017 | 19 Aug, 2030 | Deferred |
About Copaxone
Copaxone is a drug owned by Teva Pharmaceuticals Usa. It is used for treating multiple sclerosis. Copaxone uses Glatiramer Acetate as an active ingredient. Copaxone was launched by Teva Pharms Usa in 1996.
Approval Date:
Copaxone was approved by FDA for market use on 20 December, 1996.
Active Ingredient:
Copaxone uses Glatiramer Acetate as the active ingredient. Check out other Drugs and Companies using Glatiramer Acetate ingredient
Treatment:
Copaxone is used for treating multiple sclerosis.
Dosage:
Copaxone is available in the following dosage forms - injectable form for subcutaneous use, for solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/ML | INJECTABLE | Prescription | SUBCUTANEOUS |
| 20MG/VIAL | FOR SOLUTION | Discontinued | SUBCUTANEOUS |
| 20MG/ML | INJECTABLE | Prescription | SUBCUTANEOUS |