Tecfidera is a drug owned by Biogen Inc. It is protected by 15 US drug patents filed from 2013 to 2022. Out of these, 9 drug patents are active and 6 have expired. Tecfidera's patents have been open to challenges since 27 March, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 16, 2035. Details of Tecfidera'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). | |||
| US11129806 | Methods of treating multiple sclerosis |
Nov, 2035
(10 years from now) | Active |
| US10959972 | Methods of treating multiple sclerosis |
Nov, 2035
(10 years from now) | Active |
| US11246850 | Methods of treating multiple sclerosis |
Nov, 2035
(10 years from now) | Active |
| US11007166 | Methods of treating multiple sclerosis |
Nov, 2035
(10 years from now) | Active |
| US11007167 | Methods of treating multiple sclerosis |
Nov, 2035
(10 years from now) | Active |
| US10391160 | Dimethyl fumarate and vaccination regimens |
Mar, 2035
(9 years from now) | Active |
| US10994003 | Dimethyl fumarate and vaccination regimens |
Mar, 2035
(9 years from now) | Active |
| US10555993 | Dimethyl fumarate and vaccination regimens |
Mar, 2035
(9 years from now) | Active |
| US8399514 | Treatment for multiple sclerosis |
Feb, 2028
(2 years from now) | Active |
| US7320999 | Dimethyl fumarate for the treatment of multiple sclerosis |
May, 2020
(4 years ago) |
Expired
|
| US6509376 | Utilization of dialkyfumarates |
Oct, 2019
(5 years ago) |
Expired
|
| US8759393 | Utilization of dialkylfumarates |
Jul, 2018
(6 years ago) |
Expired
|
| US7619001 | Utilization of dialkylfumarates |
Apr, 2018
(7 years ago) |
Expired
|
| US7803840 | Utilization of dialkylfumarates |
Apr, 2018
(7 years ago) |
Expired
|
| US8524773 | Utilization of dialkylfumarates |
Apr, 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 Tecfidera's patents.
Latest Legal Activities on Tecfidera's Patents
Given below is the list of recent legal activities going on the following patents of Tecfidera.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 18 Mar, 2024 | US10555993 |
| Maintenance Fee Reminder Mailed Critical | 02 Oct, 2023 | US10555993 |
| Termination or Final Written Decision | 03 Feb, 2023 | US8399514 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jan, 2023 | US10391160 |
| Expire Patent Critical | 31 Oct, 2022 | US7803840 |
| Expire Patent Critical | 01 Aug, 2022 | US8759393 |
| Maintenance Fee Reminder Mailed Critical | 16 May, 2022 | US7803840 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Feb, 2022 | US11246850 |
| Recordation of Patent Grant Mailed Critical | 15 Feb, 2022 | US11246850 |
| Maintenance Fee Reminder Mailed Critical | 14 Feb, 2022 | US8759393 |
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 Tecfidera and ongoing litigations to help you estimate the early arrival of Tecfidera generic.
Tecfidera's Litigations
Tecfidera been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 01, 2015, against patent number US8399514. The petitioner Coalition for Affordable Drugs V LLC, challenged the validity of this patent, with Biogen MA Inc. as the respondent. Click below to track the latest information on how companies are challenging Tecfidera's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8399514 | July, 2018 |
Final Written Decision
(03 Feb, 2023) | Biogen MA Inc. | Mylan Pharmaceuticals Inc. et al. |
| US8399514 | March, 2019 |
Terminated
(11 Sep, 2019) | Biogen MA Inc. | Sawai USA, Inc. et al. |
| US8399514 | September, 2015 |
FWD Entered
(21 Mar, 2017) | Biogen Idec MA Inc | Coalition For Affordable Drugs V LLC |
| US8759393 | April, 2015 |
Terminated-Denied
(27 Oct, 2015) | Biogen International GmbH | Coalition For Affordable Drugs V LLC |
| US8399514 | May, 2015 |
Terminated-Denied
(02 Sep, 2015) | Biogen MA Inc. | Coalition for Affordable Drugs V LLC |
FDA has granted some exclusivities to Tecfidera. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tecfidera, 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 Tecfidera.
Exclusivity Information
Tecfidera holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Tecfidera's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 27, 2018 |
| M(M-260) | Feb 05, 2023 |
Several oppositions have been filed on Tecfidera'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 Tecfidera's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tecfidera patents.
Tecfidera's Oppositions Filed in EPO
Tecfidera has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 05, 2014, by Zentiva K.S.. This opposition was filed on patent number EP08725256A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP13169139A | Apr, 2023 | Dr. Schön, Neymeyr & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP13169139A | Apr, 2023 | BIOGARAN | Granted and Under Opposition |
| EP13169139A | Apr, 2023 | Kraus & Weisert Patentanwälte PartGmbB | Granted and Under Opposition |
| EP13169139A | Apr, 2023 | Glenmark Pharmaceuticals Europe Ltd | Granted and Under Opposition |
| EP13169139A | Apr, 2023 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP13169139A | Apr, 2023 | Adalvo Ltd. | Granted and Under Opposition |
| EP13169139A | Mar, 2023 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Granted and Under Opposition |
| EP13169139A | Feb, 2023 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP13169139A | Oct, 2022 | G. L. Pharma GmbH | Granted and Under Opposition |
| EP13169139A | Sep, 2022 | Zentiva k.s. | Granted and Under Opposition |
| EP13169139A | Jul, 2022 | Polpharma S.A. | Granted and Under Opposition |
| EP13169139A | Jul, 2022 | Hexal AG | Granted and Under Opposition |
| EP13169139A | Jul, 2022 | Generics [UK] Limited (trading as Mylan) | Granted and Under Opposition |
| EP13169139A | Jul, 2022 | neuraxpharm Arzneimittel GmbH | Granted and Under Opposition |
| EP08725256A | Feb, 2014 | Actavis Group PTC ehf | Revoked |
| EP08725256A | Feb, 2014 | Forward Pharma A/S | Revoked |
| EP08725256A | Feb, 2014 | Synthon B.V. | Revoked |
| EP08725256A | Feb, 2014 | Gallafent, Antony Xavier | Revoked |
| EP08725256A | Feb, 2014 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Revoked |
| EP08725256A | Feb, 2014 | Generics [UK] Limited | Revoked |
| EP08725256A | Feb, 2014 | European Opposition Limited | Revoked |
| EP08725256A | Feb, 2014 | G. L. Pharma GmbH | Revoked |
| EP08725256A | Feb, 2014 | Hexal AG | Revoked |
| EP08725256A | Feb, 2014 | Zentiva k.s. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Tecfidera 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 Tecfidera's family patents as well as insights into ongoing legal events on those patents.
Tecfidera's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tecfidera's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 16, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tecfidera Generic API suppliers:
Dimethyl Fumarate is the generic name for the brand Tecfidera. 17 different companies have already filed for the generic of Tecfidera, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tecfidera's generic
How can I launch a generic of Tecfidera before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tecfidera's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tecfidera'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 Tecfidera -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 120 mg and 240 mg | 27 Mar, 2017 | 29 | 17 Aug, 2020 | 07 Feb, 2028 | Deferred |
Alternative Brands for Tecfidera
Tecfidera which is used for treating autoimmune diseases such as multiple sclerosis and relapsing forms before and after administering an inactive vaccine., 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.
About Tecfidera
Tecfidera is a drug owned by Biogen Inc. It is used for treating autoimmune diseases such as multiple sclerosis and relapsing forms before and after administering an inactive vaccine. Tecfidera uses Dimethyl Fumarate as an active ingredient. Tecfidera was launched by Biogen Inc in 2013.
Approval Date:
Tecfidera was approved by FDA for market use on 27 March, 2013.
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 Tecfidera is 27 March, 2013, its NCE-1 date is estimated to be 27 March, 2017.
Active Ingredient:
Tecfidera uses Dimethyl Fumarate as the active ingredient. Check out other Drugs and Companies using Dimethyl Fumarate ingredient
Treatment:
Tecfidera is used for treating autoimmune diseases such as multiple sclerosis and relapsing forms before and after administering an inactive vaccine.
Dosage:
Tecfidera is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 120MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 240MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |