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, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin Atlantis, MSN, Mylan, Twi Pharms, Zydus Pharms, and Biogen Idec Inc, and is included in twelve NDAs. 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. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dimethyl fumarate

International Patents:	69
US Patents:	2
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	76
Suppliers / Packagers:	17
Bulk Api Vendors:	106
Clinical Trials:	64
Patent Applications:	9
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
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
Assistance Publique - Hôpitaux de Paris	Phase 2
Almirall, S.A.	Phase 4
Banner Life Sciences LLC	Phase 1

See all dimethyl fumarate clinical trials

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

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	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
Mylan	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210531-002	Aug 17, 2020	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Biogen Idec Inc	TECFIDERA	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	204063-002	Mar 27, 2013	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Mylan	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210531-001	Aug 17, 2020	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Msn	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210460-002	Sep 24, 2020	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Msn	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210460-001	Sep 24, 2020	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Glenmark Pharms Ltd	DIMETHYL FUMARATE	dimethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210309-001	Oct 6, 2020	AB	RX	No	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	204063-001	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
>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
Estonia	200100266	Start Trial
Japan	2002530324	Start Trial
Japan	2016047830	Start Trial
Estonia	04389	Start Trial
European Patent Office	2653873	Start Trial
European Patent Office	2137537	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
1131065	1490039-3	Sweden	Start Trial	PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
1131065	39/2014	Austria	Start Trial	PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537	92487	Luxembourg	Start Trial	PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
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	PA2014024	Lithuania	Start Trial	PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537	310 5015-2014	Slovakia	Start Trial	PRODUCT NAME: DIMETYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001 - EU/1/13/837/002 20140203
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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