.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Fuji
Chubb
Novartis
Harvard Business School
Julphar
Argus Health
Queensland Health
AstraZeneca
Accenture
Boehringer Ingelheim

Generated: December 14, 2017

DrugPatentWatch Database Preview

Dimethyl fumarate - Generic Drug Details

« Back to Dashboard

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.

Medical Subject Heading (MeSH) Categories for dimethyl fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Biogen Idec IncTECFIDERAdimethyl fumarateCAPSULE, DELAYED RELEASE;ORAL204063-002Mar 27, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: dimethyl fumarate

Country Document Number Estimated Expiration
Czech Republic20010939► Subscribe
European Patent Office2680007► Subscribe
Estonia04389► Subscribe
Estonia200100266► Subscribe
MexicoPA01005007► Subscribe
Czech Republic299409► Subscribe
Portugal2137537► Subscribe
Luxembourg92488► Subscribe
Norway20011242► Subscribe
Serbia49995► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: DIMETHYL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
/2014Austria► SubscribePRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
90039-3Sweden► SubscribePRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
01C/040Belgium► SubscribePRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113
00675Netherlands► SubscribePRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2014 00036Denmark► SubscribePRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
2014000069Germany► SubscribePRODUCT NAME: DIMETHYLFUMARAT; 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
487Luxembourg► SubscribePRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
00674Netherlands► SubscribePRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Cerilliant
McKesson
Cipla
Express Scripts
Medtronic
Novartis
McKinsey
Baxter
Chubb

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot