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Last Updated: March 1, 2021

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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 Atlantis, MSN, Mylan, Twi Pharms, Zydus Pharms, and Biogen Idec Inc, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has sixty-nine patent family members in thirty-two countries.

There are seventy-six drug master file entries for dimethyl fumarate. Seventeen 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
Almirall, S.A.Phase 4
Banner Life Sciences LLCPhase 1

See all dimethyl fumarate clinical trials

Generic filers with tentative approvals for DIMETHYL FUMARATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial240MGCAPSULE, DELAYED RELEASE;ORAL
  Start Trial  Start 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
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
Mylan DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210531-002 Aug 17, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210531-001 Aug 17, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Msn DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210460-002 Sep 24, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Msn DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210460-001 Sep 24, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210309-001 Oct 6, 2020 AB RX No No   Start Trial   Start Trial   Start 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 Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013   Start Trial   Start Trial
>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
1131065 1490039-3 Sweden   Start Trial PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
1131065 39/2014 Austria   Start Trial PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537 92487 Luxembourg   Start Trial PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
1761528 CA 2014 00055 Denmark   Start 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 20140630
2137537 PA2014024 Lithuania   Start Trial PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537 310 5015-2014 Slovakia   Start Trial PRODUCT NAME: DIMETYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001 - EU/1/13/837/002 20140203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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