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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Baxter
Express Scripts
Chinese Patent Office
Moodys
Cantor Fitzgerald
Boehringer Ingelheim
US Department of Justice
Novartis
Daiichi Sankyo

Generated: October 19, 2017

DrugPatentWatch Database Preview

TECFIDERA Drug Profile

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Which patents cover Tecfidera, and what generic Tecfidera alternatives are available?

Tecfidera is a drug marketed by Biogen Idec Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-seven patent family members in thirty-two countries and nineteen supplementary protection certificates in nine countries.

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dimethyl fumarate profile page.

Summary for Tradename: TECFIDERA

US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list70
Clinical Trials: see list50
Patent Applications: see list3,150
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TECFIDERA 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► 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;ORAL204063-001Mar 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;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for TECFIDERA

Drugname Dosage Strength RLD Submissiondate
dimethyl fumarateDelayed-releaseCapsules120 mg and 240 mgTecfidera3/27/2017

Non-Orange Book Patents for Tradename: TECFIDERA

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 Tradename: TECFIDERA

Country Document Number Estimated Expiration
Japan2012255020► Subscribe
Estonia200100266► Subscribe
Israel142728► Subscribe
Australia752733► Subscribe
Slovakia285601► Subscribe
China1182844► Subscribe
Norway333257► Subscribe
Japan2009256384► Subscribe
Slovenia1131065► Subscribe
Poland226074► 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: TECFIDERA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90039-3Sweden► SubscribePRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
00675Netherlands► SubscribePRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2014024Lithuania► SubscribePRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2014023Lithuania► SubscribePRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
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
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
2014 00036Denmark► SubscribePRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. 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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Cipla
Teva
Express Scripts
McKinsey
Dow
Fuji
Covington
Johnson and Johnson
Cerilliant

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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