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Dimethyl fumarate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dimethyl fumarate?

Dimethyl fumarate is the generic ingredient in one branded drug marketed by Biogen Idec Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-nine patent family members in thirty-one countries.

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

Summary for Generic Name: dimethyl fumarate

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list73
Suppliers / Packagers: see list1
Bulk Api Vendors: see list70
Clinical Trials: see list257
Patent Applications: see list3,064
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dimethyl fumarate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo8,759,393► SubscribeY ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo7,619,001► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes7,619,001► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes8,524,773► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dimethyl fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,915,310Utilization of dialkylfumarates► Subscribe
7,612,110Utilization of dialkylfumarates► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: dimethyl fumarate

Country Document Number Estimated Expiration
Serbia52922► Subscribe
European Patent Office2137537► Subscribe
Canada2346438► Subscribe
Japan2012255020► Subscribe
Yugoslavia29901► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DIMETHYL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00674Netherlands► SubscribePRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
C/GB98/002United Kingdom► SubscribePRODUCT 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
90038-5Sweden► SubscribePRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
90039-3Sweden► SubscribePRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
2014 00035Denmark► SubscribePRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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