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Last Updated: February 26, 2024

Dimethyl fumarate - Generic Drug Details


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What are the generic drug sources for dimethyl fumarate and what is the scope of patent protection?

Dimethyl fumarate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in sixteen NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has eighty-five patent family members in twenty-nine countries.

There are twenty-eight drug master file entries for dimethyl fumarate. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for dimethyl fumarate

See drug prices for dimethyl fumarate

Recent Clinical Trials for dimethyl fumarate

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

SponsorPhase
Imcyse SAPhase 1/Phase 2
Assistance Publique - Hôpitaux de ParisPhase 2
Xuanwu Hospital, BeijingPhase 2

See all dimethyl fumarate clinical trials

Generic filers with tentative approvals for DIMETHYL FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial240MGCAPSULE, DELAYED RELEASE;ORAL
⤷  Try a Trial⤷  Try a Trial120MGCAPSULE, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for dimethyl fumarate
Anatomical Therapeutic Chemical (ATC) Classes for dimethyl fumarate
Paragraph IV (Patent) Challenges for DIMETHYL FUMARATE
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 dimethyl fumarate

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
Alkem Labs Ltd DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210440-002 Sep 24, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sola Pharms DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210436-002 Mar 26, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210531-001 Aug 17, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210309-002 Oct 6, 2020 AB RX No No ⤷  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 dimethyl fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 204063-001 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
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 dimethyl fumarate

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
Teva GmbH Dimethyl fumarate Teva dimethyl fumarate EMEA/H/C/005963
Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Authorised yes no no 2022-12-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for dimethyl fumarate

Country Patent Number Title Estimated Expiration
European Patent Office 3804711 MÉTHODES DE TRAITEMENT DE LA SCLÉROSE EN PLAQUES (METHODS OF TREATING MULTIPLE SCLEROSIS) ⤷  Try a Trial
European Patent Office 2137537 Compositions et leurs utilisations pour le traitement de la Sclérose en plaques (Compositions and Uses for Treating Multiple Sclerosis) ⤷  Try a Trial
Cyprus 1114340 ⤷  Try a Trial
Portugal 2653873 ⤷  Try a Trial
Japan 2017537089 多発性硬化症の治療方法 ⤷  Try a Trial
Croatia P20220902 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dimethyl fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1131065 CA 2014 00036 Denmark ⤷  Try a Trial PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
2137537 300674 Netherlands ⤷  Try a Trial PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537 122014000069 Germany ⤷  Try a Trial PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
0693475 CR 2010 00036 Denmark ⤷  Try a Trial PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
0605697 SPC/GB01/008 United Kingdom ⤷  Try a Trial PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
2137537 92487 Luxembourg ⤷  Try a Trial PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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