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TOVIAZ Drug Profile

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Toviaz is a drug marketed by Pfizer and is included in one NDA. It is available from five suppliers. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nineteen patent family members in thirty-three countries.

The generic ingredient in TOVIAZ is fesoterodine fumarate. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. There are ten tentative approvals for this compound. Additional details are available on the fesoterodine fumarate profile page.

Summary for Tradename: TOVIAZ

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Bulk Api Vendors: see list29
Clinical Trials: see list19
Patent Applications: see list14
Drug Prices:see details
DailyMed Link:TOVIAZ at DailyMed
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, 2008RXNo6,858,650► subscribeY ► subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-001Oct 31, 2008RXNo8,338,478► subscribeYY ► subscribe
Pfizer
TOVIAZ
fesoterodine fumarate
TABLET, EXTENDED RELEASE;ORAL022030-001Oct 31, 2008RXNo7,855,230► subscribe ► subscribe
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Paragraph IV activity for: TOVIAZ

Drugname Dosage Strength RLD Submissiondate
fesoterodine fumarateExtended-release Tablets4 mg and 8 mgToviaz10/31/2012

Non-Orange Book Patents for Tradename: TOVIAZ

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
7,230,030Derivatives of 3,3-diphenylpropylamines► subscribe
9,364,541Pharmaceutical compositions comprising Fesoterodine► 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: TOVIAZ

Country Document Number Estimated Expiration
Slovakia287430► subscribe
Slovakia286052► subscribe
Hong Kong1095736► 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: TOVIAZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007008Lithuania► subscribePRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
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
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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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