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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-eight 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.

Summary for TECFIDERA

International Patents:	68
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	89
Clinical Trials:	54
Patent Applications:	3,864
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

See drug prices for TECFIDERA

Recent Clinical Trials for TECFIDERA

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

Sponsor	Phase
Banner Life Sciences LLC	Phase 1
Patient-Centered Outcomes Research Institute	Phase 4
Universita degli Studi di Genova	Phase 4

See all TECFIDERA clinical trials

Recent Litigation for TECFIDERA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
BIOGEN INTERNATIONAL GMBH v. ZYDUS PHARMACEUTICALS (USA) INC.	2019-02-15
Biogen International GmbH v. Zydus Pharmaceuticals (USA) Inc.	2018-04-25
Biogen International GmbH v. Banner Life Sciences LLC	2018-04-18

See all TECFIDERA litigation

PTAB Litigation

Petitioner	Date
Sawai USA, Inc.	2019-03-05
Mylan Pharmaceuticals Inc.	2018-07-13
Coalition For Affordable Drugs V LLC	2015-09-28

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

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
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	204063-001	Mar 27, 2013		RX	Yes	No

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	204063-002	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	204063-002	Mar 27, 2013
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	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	Patent Number	Estimated Expiration
Germany	59905954
Slovakia	5762001
Spain	2424022
European Patent Office	2518511
Norway	333257

Supplementary Protection Certificates for TECFIDERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	CA 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
0693475	CR 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
2137537	C300674	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537	1490038-5	Sweden		PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
0300652	SPC/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