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Daiichi Sankyo
Covington
Mallinckrodt
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US Army
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Generated: September 23, 2018

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TECFIDERA Drug Profile

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When do Tecfidera patents expire, and what generic alternatives are available?

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

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.

Drug patent expirations by year for TECFIDERA
Generic Entry Opportunity Date for TECFIDERA
Generic Entry Date for TECFIDERA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for TECFIDERA
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
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
AK144835
AK144836
AKOS000121333
Allomaleic acid dimethyl ester
AN-22022
AS01220
AZL-0211089
AZL-O-211089
BC226892
BG 00012
BG 12 compound
BG-00012
BG-12
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
D0A7MY
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, 97%
Dimethyl fumarate, 99% 25g
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 (8CI)
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
LP050519
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
OR019934
OR245015
Panaclar
Pharmakon1600-01506154
RP20909
RTR-021472
s2586
SBB008222
SC-22552
SCHEMBL41835
SCHEMBL41836
SR-01000944222
SR-01000944222-1
ST2402525
ST50827963
STK039379
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

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 204063-002 Mar 27, 2013 ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 ➤ Sign Up ➤ Sign Up
Biogen Idec Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for TECFIDERA
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-releaseCapsules 120 mg and 240 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for TECFIDERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8 Finland ➤ Sign Up
C/GB98/002 United Kingdom ➤ Sign Up 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
/2014 Austria ➤ Sign Up PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2014023 Lithuania ➤ Sign Up PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
488 Luxembourg ➤ Sign Up PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
C/GB02/030 United Kingdom ➤ Sign Up PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
2014 00035 Denmark ➤ Sign Up PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
Mallinckrodt
Queensland Health
Fuji
US Army
Citi
McKesson
Express Scripts

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