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Fesoterodine fumarate - Generic Drug Details

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

This ingredient has one hundred and eighteen patent family members in thirty-three countries.

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

Summary for Generic Name: fesoterodine fumarate

Tradenames:2
Patents:8
Applicants:2
NDAs:2
Drug Master File Entries: see list13
Suppliers / Packaging: see list5
Drug Prices:see low prices

Tentative approvals for FESOTERODINE FUMARATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL4MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL8MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL4MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-001Oct 31, 2008RXNo7,855,230► subscribe ► subscribe
Alkem Labs Ltd
FESOTERODINE FUMARATE
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL204827-002Dec 10, 2015DISCNNo► subscribe► subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-002Oct 31, 2008RXYes7,985,772► subscribeYY ► 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
7,230,030Derivatives of 3,3-diphenylpropylamines► subscribe
9,364,541Pharmaceutical compositions comprising Fesoterodine► subscribe
6,713,464 Derivatives 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
Iceland2124► subscribe
Denmark1077912► subscribe
Germany29923134► 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
8Finland► subscribe
365Luxembourg► subscribe91365, EXPIRES: 20220420
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
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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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