Dimethyl fumarate - Generic Drug Details

What are the generic drug sources for dimethyl fumarate and what is the scope of patent protection?

Dimethyl fumarate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, MSN, Mylan, Sawai Usa, Sola Pharms, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in fourteen NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has seventy-three patent family members in twenty-six countries.

There are twenty-eight drug master file entries for dimethyl fumarate. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dimethyl fumarate

International Patents:	73
US Patents:	9
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	70
Patent Applications:	5,720
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for dimethyl fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dimethyl fumarate
What excipients (inactive ingredients) are in dimethyl fumarate?	dimethyl fumarate excipients list
DailyMed Link:	dimethyl fumarate at DailyMed

See drug prices for dimethyl fumarate

Recent Clinical Trials for dimethyl fumarate

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

Sponsor	Phase
Imcyse SA	Phase 1/Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 2
Xuanwu Hospital, Beijing	Phase 2

See all dimethyl fumarate clinical trials

Generic filers with tentative approvals for DIMETHYL FUMARATE

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

Paragraph IV (Patent) Challenges for DIMETHYL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TECFIDERA	Delayed-release Capsules	dimethyl fumarate	120 mg and 240 mg	204063	29	2017-03-27

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
Mylan	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210531-001	Aug 17, 2020	AB	RX	No	No
Amneal	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210402-002	Sep 24, 2020	AB	RX	No	No
Zydus Pharms	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210538-002	Sep 24, 2020		DISCN	No	No
Accord Hlthcare	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210499-002	Sep 24, 2020	AB	RX	No	No

Expired US Patents for dimethyl fumarate

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

EU/EMA Drug Approvals for dimethyl fumarate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Almirall S.A	Skilarence	dimethyl fumarate	EMEA/H/C/002157 Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.	Authorised	no	no	no	2017-06-23
Biogen Netherlands B.V.	Tecfidera	dimethyl fumarate	EMEA/H/C/002601 Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).	Authorised	no	no	no	2014-01-30
Mylan Ireland Limited	Dimethyl fumarate Mylan	dimethyl fumarate	EMEA/H/C/005956 Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.	Authorised	yes	no	no	2022-05-13
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.	Dimethyl fumarate Polpharma	dimethyl fumarate	EMEA/H/C/005955 Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.	Authorised	yes	no	no	2022-05-13

International Patents for dimethyl fumarate

Country	Patent Number	Title	Estimated Expiration
Slovenia	2137537
European Patent Office	2680008	Essais de criblage de Nrf2 et procédés et compositions correspondants (Nrf2 screening assays and related methods and compositions)
European Patent Office	3650042	FUMARATE DE DIMÉTHYLE ET RÉGIMES DE VACCINATION (DIMETHYL FUMARATE AND VACCINATION REGIMENS)
China	107106530	治疗多发性硬化的方法 (Methods of treating multiple sclerosis)

Supplementary Protection Certificates for dimethyl fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1131065	39/2014	Austria		PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
1131065	92488	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
2137537	300674	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730