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TECFIDERA Drug Profile

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Tecfidera is a drug marketed by Biogen Idec Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug.

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

The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-one 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

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXNo7,320,999► subscribe ► subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXNo8,759,393► subscribeY ► subscribe
Biogen Idec Inc
TECFIDERA
dimethyl fumarate
CAPSULE, DELAYED RELEASE;ORAL204063-001Mar 27, 2013RXNo8,399,514► subscribe ► subscribe
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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
European Patent Office2653873► subscribe
MexicoPA01005007► subscribe
European Patent Office2680008► 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
/2014Austria► subscribePRODUCT NAME: DIMETHYLFUMARAT; 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
90038-5Sweden► subscribePRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
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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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