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Serving leading biopharmaceutical companies globally:

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Teva
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Queensland Health
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Generated: November 25, 2017

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Fesoterodine fumarate - Generic Drug Details

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What are the generic sources for fesoterodine fumarate and what is the scope of fesoterodine fumarate freedom to operate?

Fesoterodine fumarate
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Alkem Labs Ltd, Pfizer, and Zydus Pharms Usa Inc, and is included in four NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fesoterodine fumarate has one hundred and thirty-one patent family members in thirty-three countries and ten supplementary protection certificates in nine countries.

There are thirteen drug master file entries for fesoterodine fumarate. Five suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for fesoterodine fumarate

Tentative approvals for FESOTERODINE FUMARATE

Applicant Application No. Strength Dosage Form
u► Subscribe4MGTABLET, EXTENDED RELEASE;ORAL
u► Subscribe8MGTABLET, EXTENDED RELEASE;ORAL
u► Subscribe8MGTABLET, EXTENDED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-002Oct 31, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-001Oct 31, 2008ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-002Oct 31, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-002Oct 31, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Aurobindo Pharma Ltd
FESOTERODINE FUMARATE
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL205007-001Feb 17, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-001Oct 31, 2008ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-001Oct 31, 2008ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-002Oct 31, 2008ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Zydus Pharms Usa Inc
FESOTERODINE FUMARATE
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL204946-001Oct 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-001Oct 31, 2008ABRXYesNo► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fesoterodine 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
6,713,464 Derivatives of 3,3-diphenylpropylamines► Subscribe
9,364,541Pharmaceutical compositions comprising Fesoterodine► Subscribe
7,230,030Derivatives of 3,3-diphenylpropylamines► 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: fesoterodine fumarate

Country Document Number Estimated Expiration
Czech Republic296605► Subscribe
Hungary226490► Subscribe
Hong Kong1084099► Subscribe
European Patent Office1077912► Subscribe
Hungary230434► Subscribe
Norway20065380► Subscribe
Turkey200003319► Subscribe
Japan2010180243► Subscribe
Czech Republic20021343► Subscribe
Slovakia288384► 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: FESOTERODINE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00046Denmark► Subscribe
8Finland► Subscribe
1077912/01Switzerland► SubscribePRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008
C/GB07/053United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/053 GRANTED TO SCHWARZ PHARMA AG IN RESPECT OF THE PRODUCT FESOTERODINE AND ITS SALTS WITH PHYSIOLOGICALLY ACCEPTABLE ACIDS, INCLUDING FUMARIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6299 DATED 10 FEBRUARY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23 APRIL 2022.
2007008,C1230209Lithuania► SubscribePRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
C0050France► SubscribePRODUCT NAME: FESOTERODINE ET SES SELS AVEC DES ACIDES PHYSIOLOGIQUEMENT ACCEPTABLES NOTAMMENT L ACIDE FUMARIQUE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/386/001 DU 20070420; REGISTRATION NO/DATE AT EEC: EU/1/07/386/001 DU 20070420
2007008Lithuania► SubscribePRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
C037/2007Ireland► SubscribeSPC037/2007: 20080507, EXPIRES: 20220419
47/2007Austria► SubscribePRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
365Luxembourg► Subscribe91365, EXPIRES: 20220420
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Serving leading biopharmaceutical companies globally:

Baxter
Chinese Patent Office
Queensland Health
McKinsey
US Army
Novartis
Daiichi Sankyo
Argus Health
Accenture
Johnson and Johnson

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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