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Teriflunomide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for teriflunomide?

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.

This ingredient has fifty-four patent family members in thirty-seven countries.

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

Summary for Generic Name: teriflunomide

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list18
Suppliers / Packagers: see list1
Bulk Api Vendors: see list53
Clinical Trials: see list18
Patent Applications: see list597
Drug Prices:see low prices
DailyMed Link:teriflunomide at DailyMed

Pharmacology for Ingredient: teriflunomide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-002Sep 12, 2012RXYesYes► Subscribe► Subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-001Sep 12, 2012RXYesNo9,186,346► Subscribe ► Subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-001Sep 12, 2012RXYesNo► Subscribe► Subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-002Sep 12, 2012RXYesYes6,794,410► Subscribe ► Subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-002Sep 12, 2012RXYesYes9,186,346► 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 Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-001Sep 12, 20125,459,163► Subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-001Sep 12, 20125,679,709► Subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-002Sep 12, 20125,459,163► Subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-002Sep 12, 20125,679,709► 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
Israel244809► Subscribe
Uruguay27244► Subscribe
TaiwanI468190► Subscribe
South Korea20120089461► Subscribe
Panama8542901► 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
14/004Ireland► SubscribePRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
2014 00005Denmark► SubscribePRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
2014 00005Denmark► SubscribePRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356/01Switzerland► SubscribePRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: SWISSMEDIC 62761 05.11.2013
366Luxembourg► SubscribePRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
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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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