Dimethyl fumarate - Generic Drug Details

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What are the generic drug sources for dimethyl fumarate and what is the scope of 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 two 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-two countries.

There are seventy-six drug master file entries for dimethyl fumarate. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for dimethyl fumarate

International Patents:	69
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	76
Suppliers / Packagers:	1
Bulk Api Vendors:	95
Clinical Trials:	63
Patent Applications:	5,621
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dimethyl fumarate
DailyMed Link:	dimethyl fumarate at DailyMed

Recent Clinical Trials for dimethyl fumarate

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 2
Almirall, S.A.	Phase 4
Banner Life Sciences LLC	Phase 1

See all dimethyl fumarate clinical trials

Recent Litigation for dimethyl fumarate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Biogen International GmbH v. Cipla Limited	2019-11-27
BIOGEN INTERNATIONAL GMBH v. ZYDUS PHARMACEUTICALS (USA) INC.	2019-02-15
Biogen International GmbH v. Banner Life Sciences LLC	2018-12-27

See all dimethyl fumarate litigation

PTAB Litigation

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

See all dimethyl fumarate litigation

Generic filers with tentative approvals for DIMETHYL FUMARATE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	240MG	CAPSULE, DELAYED RELEASE;ORAL
Start Trial	Start Trial	120MG	CAPSULE, DELAYED RELEASE;ORAL
Start Trial	Start Trial	120MG	CAPSULE, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
AI3-07872
AK144836
AKOS000121333
Allomaleic acid dimethyl ester
AS01220
AZL O 211089
AZL-0211089
AZL-O-211089
BG 00012
BG 12
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
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-butenedioate
Dimethyl trans-ethylenedicarboxylate
dimethyl-fumarate
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
FP-187
FP187
Fumaderm
Fumaric acid dimethyl
Fumaric acid dimethyl ester
Fumaric acid dimethyl ester 100 microg/mL in Methanol
Fumaric acid-dimethyl ester
Fumaric acid, dimethyl ester
GTPL7045
HMS3264D14
HSDB 7725
HY-17363
InChI=1/C6H8O4/c1-9-5(7)3-4-6(8)10-2/h3-4H,1-2H3/b4-3
LDCRTTXIJACKKU-ONEGZZNKSA-N
LS-46997
Methyl fumarate
MFCD00064438
NE10584
NSC 167432
NSC 25942
NSC-167432
NSC-25942
NSC-760139
NSC167432
NSC25942
NSC760139
Panaclar
Pharmakon1600-01506154
Q418123
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

Paragraph IV (Patent) Challenges for DIMETHYL FUMARATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
TECFIDERA	CAPSULE, DELAYED RELEASE;ORAL	dimethyl fumarate	204063	2017-03-27

US Patents and Regulatory Information for dimethyl fumarate

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Glossary

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

Expired US Patents for dimethyl fumarate

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

International Patents for dimethyl fumarate

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Country	Patent Number	Estimated Expiration
European Patent Office	1131065	Start Trial
Serbia	49995	Start Trial
European Patent Office	2653873	Start Trial
Bulgaria	105396	Start Trial
European Patent Office	2680007	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for dimethyl fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2137537	122014000069	Germany	Start Trial	PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537	CA 2014 00035	Denmark	Start Trial	PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
1131065	CA 2014 00036	Denmark	Start Trial	PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
1761528	CA 2014 00055	Denmark	Start Trial	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
2137537	C300674	Netherlands	Start Trial	PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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