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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Johnson and Johnson
McKinsey
Queensland Health
Fish and Richardson
Chubb
Express Scripts
Julphar
US Army

Generated: October 21, 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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dimethyl fumarate has sixty-seven patent family members in thirty-two countries and nineteen supplementary protection certificates in nine 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

US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list74
Suppliers / Packagers: see list1
Bulk Api Vendors: see list70
Clinical Trials: see list594
Patent Applications: see list4,958
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, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► 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
European Patent Office2137537► Subscribe
Australia752733► Subscribe
Serbia49995► Subscribe
Australia1157200► Subscribe
Hungary226689► Subscribe
Estonia04389► Subscribe
Denmark2137537► Subscribe
Norway333257► Subscribe
Japan2005097323► Subscribe
Brazil9914606► 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
00675Netherlands► 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
/2014Austria► SubscribePRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
488Luxembourg► SubscribePRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
2014000069Germany► SubscribePRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2014 00055Denmark► SubscribePRODUCT 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
00674Netherlands► SubscribePRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
C/GB03/005United Kingdom► SubscribePRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830
2014024Lithuania► SubscribePRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
C/GB02/030United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Express Scripts
Harvard Business School
Fuji
Argus Health
Merck
Teva
Daiichi Sankyo
Colorcon
Chinese Patent Office

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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