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Generated: June 27, 2017

DrugPatentWatch Database Preview

Dimethyl fumarate - Generic Drug Details

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What are the generic sources for dimethyl fumarate and what is the scope of dimethyl fumarate 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 eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has sixty patent family members in thirty-two countries.

There are seventy-four 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 list74
Suppliers / Packagers: see list1
Bulk Api Vendors: see list70
Clinical Trials: see list581
Patent Applications: see list4,549
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dimethyl fumarate at DailyMed
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;ORAL204063-001Mar 27, 2013RXYesNo6,509,376► SubscribeY ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes8,399,514► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo7,803,840► 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
7,612,110Utilization of dialkylfumarates► Subscribe
7,915,310Utilization 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
Australia1157200► Subscribe
Luxembourg92488► Subscribe
Spain2424022► Subscribe
New Zealand510247► Subscribe
Czech Republic20010939► 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
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
2010 00036Denmark► SubscribePRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
2014023Lithuania► SubscribePRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2014 00035Denmark► SubscribePRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
C/GB01/008United Kingdom► SubscribePRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Cipla
UBS
Colorcon
Julphar
QuintilesIMS
Cerilliant
Daiichi Sankyo
Dow

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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