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Last Updated: January 25, 2020

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TECFIDERA Drug Profile

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Which patents cover Tecfidera, and what generic alternatives are available?

Tecfidera is a drug marketed by Biogen Idec Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine patent family members in thirty-two countries.

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dimethyl fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Tecfidera

Tecfidera was eligible for patent challenges on March 27, 2017.

There have been thirty-six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are six tentative approvals for the generic drug (dimethyl fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for TECFIDERA
Drug Prices for TECFIDERA

See drug prices for TECFIDERA

Recent Clinical Trials for TECFIDERA

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

SponsorPhase
Banner Life Sciences LLCPhase 1
Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaPhase 4
Patient-Centered Outcomes Research InstitutePhase 4

See all TECFIDERA clinical trials

Recent Litigation for TECFIDERA

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 TECFIDERA litigation

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

See all TECFIDERA litigation

Synonyms for TECFIDERA
(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
1017900-75-2
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
AC1LCUHZ
AI3-07872
AJ-45818
AK144836
AKOS000121333
Allomaleic acid dimethyl ester
AN-22022
AS01220
AZL O 211089
AZL-0211089
AZL-O-211089
BC226892
BCP21649
BG 00012
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
CJ-10800
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
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-ethylenedicarboxylate
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
FR-1080
Fumaderm
Fumaric acid dimethyl
Fumaric acid dimethyl ester
Fumaric acid-dimethyl ester
Fumaric acid, dimethyl ester
GTPL7045
HMS3264D14
HSDB 7725
HY-17363
I14-16593
InChI=1/C6H8O4/c1-9-5(7)3-4-6(8)10-2/h3-4H,1-2H3/b4-3
KB-76619
LDCRTTXIJACKKU-ONEGZZNKSA-N
LS-46997
Methyl fumarate
MFCD00064438
MolPort-001-770-822
MolPort-004-288-380
NE10584
NSC 167432
NSC 25942
NSC-167432
NSC-25942
NSC-760139
NSC167432
NSC25942
NSC760139
Panaclar
Pharmakon1600-01506154
RP20909
RTR-021472
s2586
SBB008222
SC-22552
SCHEMBL41835
SCHEMBL41836
SR-01000944222
SR-01000944222-1
ST2402525
ST50827963
STK039379
SW219154-1
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 TECFIDERA
Tradename Dosage Ingredient NDA Submissiondate
TECFIDERA CAPSULE, DELAYED RELEASE;ORAL dimethyl fumarate 204063 2017-03-27

US Patents and Regulatory Information for TECFIDERA

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 204063-001 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
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 RX Yes Yes   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 TECFIDERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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 TECFIDERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1131065 PA2014023 Lithuania   Start Trial PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
0605697 SPC/GB01/008 United Kingdom   Start 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 122014000069 Germany   Start Trial PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
0300652 SPC/GB03/005 United Kingdom   Start Trial PRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Merck
Dow
Harvard Business School
Medtronic

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