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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Cipla
Cerilliant
Mallinckrodt
Chubb
McKinsey
Daiichi Sankyo
Julphar
US Department of Justice

Generated: December 17, 2017

DrugPatentWatch Database Preview

Teriflunomide - Generic Drug Details

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What are the generic drug sources for teriflunomide and what is the scope of teriflunomide patent protection?

Teriflunomide
is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Teriflunomide has sixty-nine patent family members in forty-two countries and eleven supplementary protection certificates in nine countries.

There are eighteen drug master file entries for teriflunomide. One supplier is listed for this compound.

Pharmacology for teriflunomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: teriflunomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: teriflunomide

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
6,569,898 United States Patent: 6569898   ( 1► 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: teriflunomide

Country Document Number Estimated Expiration
Taiwan201117838► Subscribe
European Patent Office2477611► Subscribe
Israel244809► Subscribe
Mexico2012003122► Subscribe
Tunisia2012000061► Subscribe
Uruguay32889► Subscribe
Malaysia155613► Subscribe
China102596184► Subscribe
Chile2015000047► Subscribe
Austria396719► 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: TERIFLUNOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00005Denmark► SubscribePRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
6Finland► Subscribe
90010-4Sweden► SubscribePRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
2014004,C1381356Lithuania► SubscribePRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
C0010France► SubscribePRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
00644Netherlands► SubscribePRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
366Luxembourg► SubscribePRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
1381356/01Switzerland► SubscribeFUSION; FORMER OWNER: AVENTIS PHARMACEUTICALS INC., US
2014 00005Denmark► SubscribePRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
2014004Lithuania► SubscribePRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Cantor Fitzgerald
UBS
Argus Health
Deloitte
QuintilesIMS
Federal Trade Commission
McKinsey
Express Scripts
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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