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Last Updated: May 29, 2020

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 one branded drug marketed by Biogen Idec Inc and is included in one NDA. 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. One supplier is listed for this compound. There are six tentative approvals for this compound.

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

Recent Litigation for dimethyl fumarate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Biogen International GmbH v. Cipla Limited2019-11-27
BIOGEN INTERNATIONAL GMBH v. ZYDUS PHARMACEUTICALS (USA) INC.2019-02-15
Biogen International GmbH v. Banner Life Sciences LLC2018-12-27

See all dimethyl fumarate litigation

PTAB Litigation
PetitionerDate
Sawai USA, Inc.2019-03-05
2018-07-13
Coalition For Affordable Drugs V LLC2015-09-28

See all dimethyl fumarate litigation

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
  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
Synonyms for dimethyl fumarate
(E)-but-2-enedioic acid dimethyl ester
(E)-Dimethyl fumarate
1,2-bis(methoxycarbonyl)-trans-ethylene
1,4-dimethyl (2E)-but-2-enedioate
1,4-dimethyl but-2-enedioate
2-Butenedioic acid (2E)-, 1,4-dimethyl ester
2-Butenedioic acid (2E)-, dimethyl ester
2-Butenedioic acid (E)-, dimethyl ester
2-Butenedioic acid, 1,4-dimethyl ester
2-Butenedioic acid, dimethyl ester, (2E)-
2-BUTENEDIOIC ACID, DIMETHYL ESTER, (E)-
2(E)-Butenedioic acid 1,4-dimethyl ester
23055-10-9
4-02-00-02205 (Beilstein Handbook Reference)
624-49-7
AB00172980_03
AB00172980_04
AB2000680
AI3-07872
AK144836
AKOS000121333
Allomaleic acid dimethyl ester
AS01220
AZL O 211089
AZL-0211089
AZL-O-211089
BG 00012
BG 12
BG 12 [Fumarate]
BG 12 compound
BG-00012
BG-12
BG-12 [Fumarate]
BG00012
BIS-METHYL ESTER
Boletic acid dimethyl ester
BRD-K31111078-001-01-8
BRN 0774590
But-2-enedioic acid, dimethyl ester
CCG-213618
CHEBI:76004
CHEMBL2107333
CS-0909
D03846
DB08908
Dimethyl (2e)-2-butenedioate
dimethyl (2E)-but-2-enedioate
dimethyl (2E)but-2-ene-1,4-dioate
Dimethyl (E)-but-2-enedioate
Dimethyl 2-butenedioate
Dimethyl fumar
Dimethyl fumarate (JAN/USAN)
Dimethyl fumarate [USAN]
Dimethyl fumarate, 97%
Dimethyl fumarate, 99%
Dimethyl fumarate, certified reference material, TraceCERT(R)
Dimethyl fumarate, Vetec(TM) reagent grade, 97%
dimethyl trans-butenedioate
Dimethyl trans-ethylenedicarboxylate
dimethyl-fumarate
Dimethylester kyseliny fumarove
Dimethylester kyseliny fumarove [Czech]
Dimethylfumarate
DTXSID4060787
EINECS 210-849-0
Ethylene, 1,2-bis(methoxycarbonyl)-, trans-
Ethylene,2-bis(methoxycarbonyl)-, trans-
F0001-1675
F0069
FAG 201
FAG-201
FAG201
FO2303MNI2
FP-187
FP187
Fumaderm
Fumaric acid dimethyl
Fumaric acid dimethyl ester
Fumaric acid dimethyl ester 100 microg/mL in Methanol
Fumaric acid-dimethyl ester
Fumaric acid, dimethyl ester
GTPL7045
HMS3264D14
HSDB 7725
HY-17363
InChI=1/C6H8O4/c1-9-5(7)3-4-6(8)10-2/h3-4H,1-2H3/b4-3
LDCRTTXIJACKKU-ONEGZZNKSA-N
LS-46997
Methyl fumarate
MFCD00064438
NE10584
NSC 167432
NSC 25942
NSC-167432
NSC-25942
NSC-760139
NSC167432
NSC25942
NSC760139
Panaclar
Pharmakon1600-01506154
Q418123
RTR-021472
s2586
SBB008222
SC-22552
SCHEMBL41835
SCHEMBL41836
SR-01000944222
SR-01000944222-1
ST2402525
ST50827963
STK039379
SW219154-1
Tecfidera
Tecfidera (TN)
TIMTEC-BB SBB008222
TL 353
TR-021472
trans-1,2-Ethylenedicarboxylic acid dimethyl ester
trans-Butenedioic acid dimethyl ester
UKRORGSYN-BB BBR-008913
UNII-FO2303MNI2
W-5060
WLN: 1OV1U1VO1 -T
ZINC100509880
ZINC3843378
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 Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 RX Yes 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 204063-002 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
2137537 122014000069 Germany   Start Trial PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537 CA 2014 00035 Denmark   Start Trial PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
1131065 CA 2014 00036 Denmark   Start Trial PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
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 C300674 Netherlands   Start Trial PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION 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:

Dow
Harvard Business School
Moodys
Express Scripts
Medtronic
Boehringer Ingelheim

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