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Last Updated: February 26, 2024

TOVIAZ Drug Patent Profile


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When do Toviaz patents expire, and when can generic versions of Toviaz launch?

Toviaz is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in twenty-nine countries.

The generic ingredient in TOVIAZ is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Toviaz

A generic version of TOVIAZ was approved as fesoterodine fumarate by ALKEM LABS LTD on December 10th, 2015.

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Drug patent expirations by year for TOVIAZ
Drug Prices for TOVIAZ

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Drug Sales Revenue Trends for TOVIAZ

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Recent Clinical Trials for TOVIAZ

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sir Mortimer B. Davis - Jewish General HospitalPhase 4
University of AlbertaPhase 2
University of British ColumbiaPhase 2

See all TOVIAZ clinical trials

Paragraph IV (Patent) Challenges for TOVIAZ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TOVIAZ Extended-release Tablets fesoterodine fumarate 4 mg and 8 mg 022030 16 2012-10-31

US Patents and Regulatory Information for TOVIAZ

TOVIAZ is protected by four US patents and two FDA Regulatory Exclusivities.

Patents protecting TOVIAZ

Stable salts of novel derivatives of 3,3-diphenylpropylamines
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions comprising fesoterodine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions comprising fesoterodine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions comprising fesoterodine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting TOVIAZ

TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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;ORAL 022030-001 Oct 31, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TOVIAZ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TOVIAZ

See the table below for patents covering TOVIAZ around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1045148 ⤷  Try a Trial
Slovenia 1481964 ⤷  Try a Trial
Hungary 226490 NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES, PROCESS FOR PREPARING THEM, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND METHODS OF USE THEM ⤷  Try a Trial
Poland 195581 ⤷  Try a Trial
Japan 5717824 ⤷  Try a Trial
Japan 4833884 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TOVIAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1077912 SPC037/2007 Ireland ⤷  Try a Trial SPC037/2007: 20080507, EXPIRES: 20220419
1481964 C 2007 098 Romania ⤷  Try a Trial PRODUCT NAME: FUMARATACID DE FESOTERODINA IN FORMA CRISTALINA 2[(1R)-3-(DIIZOPROPILAMINO)-1-FENILPROPIL]-4-(HIDROXIMETIL)FENILIZOBUTIRIC INFORMA CRISTALINA - FUMARAT ACID DE FESOTERODINA IN FORMA CRISTALINA; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/386/001, RO EU/1/07/386/002, RO EU/1/07/386/003, RO EU/1/07/386/004, RO EU/1/07/386/005, RO EU/1/07/386/006, RO EU/1/07/386/007, RO EU/1/07/386/008, RO EU/1/07/386/009, RO EU/1/07/386/010; DATE OF NATIONAL AUTHORISATION: 20070420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/386/001, EU/1/07/386/002, EU/1/07/386/003, EU/1/07/386/004, EU/1/07/386/005, EU/1/07/386/006, EU/1/07/386/007, EU/1/07/386/0 [...]
1230209 PA2007008,C1230209 Lithuania ⤷  Try a Trial PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912 CA 2007 00046 Denmark ⤷  Try a Trial PRODUCT NAME: FESOTERODIN, FUMARAT
1230209 PA2007008 Lithuania ⤷  Try a Trial PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912 SZ 47/2007 Austria ⤷  Try a Trial PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Boehringer Ingelheim
Mallinckrodt
Medtronic
Colorcon

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