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Last Updated: April 23, 2024

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 two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in sixteen 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 eighty-seven patent family members in twenty-nine countries.

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

Summary for dimethyl fumarate

International Patents:	87
US Patents:	9
Tradenames:	2
Applicants:	16
NDAs:	16
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	71
Patent Applications:	5,478
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
⤷ Try a Trial	⤷ Try a Trial	240MG	CAPSULE, DELAYED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a 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

Anatomical Therapeutic Chemical (ATC) Classes for dimethyl fumarate

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating 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

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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
Zydus Pharms	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210538-002	Sep 24, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210531-002	Aug 17, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210305-002	Sep 24, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hetero Labs Ltd Iii	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210500-002	Sep 24, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	⤷ Try a Trial	⤷ Try a Trial
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	⤷ Try a Trial	⤷ Try a Trial
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	⤷ Try a Trial	⤷ Try a Trial
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	⤷ Try a Trial	⤷ Try a Trial
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	⤷ Try a Trial	⤷ Try a Trial
Biogen Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-001	Mar 27, 2013	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for dimethyl fumarate

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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
Laboratorios Lesvi S.L.	Dimethyl fumarate Neuraxpharm	dimethyl fumarate	EMEA/H/C/006039 Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.	Authorised	yes	no	no	2022-05-13
Teva GmbH	Dimethyl fumarate Teva	dimethyl fumarate	EMEA/H/C/005963 Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).	Authorised	yes	no	no	2022-12-12
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for dimethyl fumarate

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Country	Patent Number	Title	Estimated Expiration
Portugal	2137537		⤷ Try a Trial
Serbia	52922	PREPARATI ZA LEČENJE MULTIPLE SKLEROZE I NJIHOVE UPOTREBE (COMPOSITIONS AND USES FOR TREATING MULTIPLE SCLEROSIS)	⤷ Try a Trial
China	107106530	治疗多发性硬化的方法 (Methods of treating multiple sclerosis)	⤷ Try a Trial
France	14C0050		⤷ Try a Trial
Norway	2023001		⤷ Try a Trial
Slovenia	2653873		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dimethyl fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2653873	PA2023503	Lithuania	⤷ Try a Trial	PRODUCT NAME: DIMETILFUMARATAS; REGISTRATION NO/DATE: EU/1/13/837 20140130
1761528	CR 2014 00055	Denmark	⤷ Try a 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 20140702
2137537	1490038-5	Sweden	⤷ Try a Trial	PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
2653873	122023000006	Germany	⤷ Try a Trial	PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837 20140130
0526708	SPC/GB02/030	United Kingdom	⤷ Try a Trial	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
2137537	CA 2014 00035	Denmark	⤷ Try a Trial	PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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