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Last Updated: November 26, 2022

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, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, MSN, Mylan, Sawai Usa, Sola Pharms, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in fourteen 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 seventy-three patent family members in twenty-six countries.

There are twenty-eight drug master file entries for dimethyl fumarate. Sixteen 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
See Plans and PricingSee Plans and Pricing120MGCAPSULE, DELAYED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing240MGCAPSULE, 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
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
Mylan DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210531-001 Aug 17, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210402-002 Sep 24, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210538-002 Sep 24, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210499-002 Sep 24, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 204063-002 Mar 27, 2013 See Plans and Pricing See Plans and Pricing
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 See Plans and Pricing See Plans and Pricing
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 See Plans and Pricing See Plans and Pricing
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 See Plans and Pricing See Plans and Pricing
>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
>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
Slovenia 2137537 See Plans and Pricing
European Patent Office 2680008 Essais de criblage de Nrf2 et procédés et compositions correspondants (Nrf2 screening assays and related methods and compositions) See Plans and Pricing
European Patent Office 3650042 FUMARATE DE DIMÉTHYLE ET RÉGIMES DE VACCINATION (DIMETHYL FUMARATE AND VACCINATION REGIMENS) See Plans and Pricing
China 107106530 治疗多发性硬化的方法 (Methods of treating multiple sclerosis) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dimethyl fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1131065 39/2014 Austria See Plans and Pricing PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
1131065 92488 Luxembourg See Plans and Pricing PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
2137537 300674 Netherlands See Plans and Pricing PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
0284288 SPC/GB98/002 United Kingdom See Plans and Pricing PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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