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Dimethyl fumarate - Generic Drug Details

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What are the generic sources for dimethyl fumarate and what is the scope of dimethyl fumarate 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has sixty-eight 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.

Summary for dimethyl fumarate

International Patents:	68
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	76
Suppliers / Packagers:	1
Bulk Api Vendors:	90
Clinical Trials:	59
Patent Applications:	5,402
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dimethyl fumarate
DailyMed Link:	dimethyl fumarate at DailyMed

Medical Subject Heading (MeSH) Categories for dimethyl fumarate

Dermatologic Agents

Immunosuppressive Agents

Radiation-Sensitizing Agents

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

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 (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

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 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	204063-001	Mar 27, 2013		RX	Yes	No			Y
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013		RX	Yes	No
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013		RX	Yes	No
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013		RX	Yes	Yes

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

International Patents for dimethyl fumarate

Country	Patent Number	Estimated Expiration
China	1615839
European Patent Office	2680010
European Patent Office	2137537
Japan	2009256384

Supplementary Protection Certificates for dimethyl fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0605697	SPC/GB01/008	United Kingdom		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	2014C/039	Belgium		PRODUCT NAME: DIMETHYL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/13/837/001 20140203
2137537	SPC/GB14/046	United Kingdom		PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203
1131065	PA2014023	Lithuania		PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130