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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 seven 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-three 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:	69
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	76
Suppliers / Packagers:	1
Bulk Api Vendors:	81
Clinical Trials:	57
Patent Applications:	5,237
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

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 (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

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

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

Non-Orange Book US Patents for dimethyl fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,612,110	Utilization of dialkylfumarates
7,915,310	Utilization of dialkylfumarates

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International Patents for dimethyl fumarate

Country	Document Number	Estimated Expiration
Cyprus	1114340
Serbia	49995
Japan	2002530324
China	1325302
Estonia	200100266
Czech Republic	299409

Supplementary Protection Certificates for dimethyl fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90038-5	Sweden		PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
90039-3	Sweden		PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
01C/040	Belgium		PRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113
2014 00035	Denmark		PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
2010 00036	Denmark		PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
2014 00055	Denmark		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