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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 seven patents protecting this drug and one Paragraph IV challenge.

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

Summary for TECFIDERA

International Patents:	69
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	89
Clinical Trials:	52
Patent Applications:	3,701
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TECFIDERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TECFIDERA
DailyMed Link:	TECFIDERA at DailyMed

Generic Entry Opportunity Date for TECFIDERA

NDA:

204063

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

Dermatologic Agents

Immunosuppressive Agents

Radiation-Sensitizing Agents

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			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
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

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
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

Paragraph IV (Patent) Challenges for TECFIDERA

Drugname	Dosage	Strength	RLD	Date
	Delayed-releaseCapsules	120 mg and 240 mg

International Patents for TECFIDERA

Country	Document Number	Estimated Expiration
Slovenia	1131065
World Intellectual Property Organization (WIPO)	0030622
Germany	59905954
Cyprus	1114340
Portugal	2137537
Hungary	0103182
Mexico	PA01005007

Supplementary Protection Certificates for TECFIDERA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
C/GB03/005	United Kingdom		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
C/GB02/030	United Kingdom		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
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
2014024	Lithuania		PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
00674	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
C/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