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Last Updated: November 27, 2021

DrugPatentWatch Database Preview

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, Pharmathen, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in thirteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has fifty-four patent family members in twenty-two countries.

There are seventy-six 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
Assistance Publique - Hôpitaux de ParisPhase 2
Xuanwu Hospital, BeijingPhase 2
Bill and Melinda Gates FoundationPhase 2/Phase 3

See all dimethyl fumarate clinical trials

Generic filers with tentative approvals for DIMETHYL FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free240MGCAPSULE, DELAYED RELEASE;ORAL
⤷  Try it Free⤷  Try it Free120MGCAPSULE, 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 NDA Submissiondate
TECFIDERA CAPSULE, DELAYED RELEASE;ORAL dimethyl fumarate 204063 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 it Free ⤷  Try it Free ⤷  Try it Free
Cipla DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210305-001 Sep 24, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Pharms Ltd DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210309-001 Oct 6, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Msn DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210460-002 Sep 24, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210531-002 Aug 17, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ⤷  Try it Free ⤷  Try it Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for dimethyl fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137537 C300674 Netherlands ⤷  Try it Free PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537 PA2014024 Lithuania ⤷  Try it Free PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537 92487 Luxembourg ⤷  Try it Free PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
1131065 1490039-3 Sweden ⤷  Try it Free PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
1131065 PA2014023 Lithuania ⤷  Try it Free PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
1131065 CA 2014 00036 Denmark ⤷  Try it Free PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
2137537 CA 2014 00035 Denmark ⤷  Try it Free 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

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Merck
McKinsey
Colorcon
Medtronic

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