You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

TECFIDERA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Tecfidera patents expire, and what generic alternatives are available?

Tecfidera is a drug marketed by Biogen Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-five patent family members in twenty-nine countries.

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tecfidera

A generic version of TECFIDERA was approved as dimethyl fumarate by MYLAN on August 17th, 2020.

  Try a Trial

Drug patent expirations by year for TECFIDERA
Drug Prices for TECFIDERA

See drug prices for TECFIDERA

Recent Clinical Trials for TECFIDERA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 2
Banner Life Sciences LLCPhase 1
Fondation Ophtalmologique Adolphe de RothschildPhase 4

See all TECFIDERA clinical trials

Paragraph IV (Patent) Challenges for TECFIDERA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TECFIDERA Delayed-release Capsules dimethyl fumarate 120 mg and 240 mg 204063 29 2017-03-27

US Patents and Regulatory Information for TECFIDERA

TECFIDERA is protected by nine US patents.

Patents protecting TECFIDERA

Dimethyl fumarate and vaccination regimens
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE

Dimethyl fumarate and vaccination regimens
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE

Methods of treating multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Dimethyl fumarate and vaccination regimens
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE

Methods of treating multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Methods of treating multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Methods of treating multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Methods of treating multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Treatment for multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TECFIDERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TECFIDERA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Almirall S.A Skilarence dimethyl fumarate EMEA/H/C/002157
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Authorised no no no 2017-06-23
Biogen Netherlands B.V. Tecfidera dimethyl fumarate EMEA/H/C/002601
Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Authorised no no no 2014-01-30
Mylan Ireland Limited Dimethyl fumarate Mylan dimethyl fumarate EMEA/H/C/005956
Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Authorised yes no no 2022-05-13
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. Dimethyl fumarate Polpharma dimethyl fumarate EMEA/H/C/005955
Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Authorised yes no no 2022-05-13
Laboratorios Lesvi S.L. Dimethyl fumarate Neuraxpharm dimethyl fumarate EMEA/H/C/006039
Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Authorised yes no no 2022-05-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TECFIDERA

See the table below for patents covering TECFIDERA around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1139204 COMPOSITIONS AND USES FOR TREATING MULTIPLE SCLEROSIS ⤷  Try a Trial
European Patent Office 2680010 Essais de criblage de nrf2 et procédés et compositions correspondants (Nrf2 screening assays and related methods and compositions) ⤷  Try a Trial
Spain 2424022 ⤷  Try a Trial
Croatia P20220902 ⤷  Try a Trial
China 1325302 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TECFIDERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137537 PA2014024,C2137537 Lithuania ⤷  Try a Trial PRODUCT NAME: DIMETILFUMARATAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537 1490038-5 Sweden ⤷  Try a Trial PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
2137537 PA2014024 Lithuania ⤷  Try a Trial PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
1761528 CR 2014 00055 Denmark ⤷  Try a Trial PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140702
2137537 CA 2014 00035 Denmark ⤷  Try a Trial PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.