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Last Updated: September 26, 2022

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. Eight suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising fesoterodine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising fesoterodine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising fesoterodine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
>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
Brazil 0015610 composto derivado de 3,3-difenilpropilamina, processo para preparação do mesmo, utilização de intermediários na obtenção do referido composto See Plans and Pricing
Slovakia 286052 See Plans and Pricing
Slovakia 6572002 STABLE SALTS OF NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES See Plans and Pricing
Hong Kong 1067114 See Plans and Pricing
Poland 356766 See Plans and Pricing
Norway 323920 See Plans and Pricing
Ukraine 73324 Translated By PlajСТОЙКИЕ СОЛИ ПРОИЗВОДНЫХ 3,3-ДИФЕНИЛПРОПИЛАМИНОВ И СПОСОБ ИХ ПОЛУЧЕНИЯ (ВАРИАНТЫ);СТІЙКІ СОЛІ ПОХІДНИХ 3,3-ДИФЕНІЛПРОПІЛАМІНІВ ТА СПОСІБ ЇХ ОДЕРЖАННЯ (ВАРІАНТИ) (3,3-DIPHENYLPROPYLAMINES DERIVATIVES STABLE SALTS AND A METHOD FOR THE PREPARATION THEREOF (VARIANTS)) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TOVIAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1077912 SZ 47/2007 Austria See Plans and Pricing PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
1230209 PA2007008,C1230209 Lithuania See Plans and Pricing PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912 SPC/GB07/053 United Kingdom See Plans and Pricing SUPPLEMENTARY 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.
1077912 CA 2007 00046 Denmark See Plans and Pricing PRODUCT NAME: FESOTERODIN, FUMARAT
1230209 PA2007008 Lithuania See Plans and Pricing PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912 07C0050 France See Plans and Pricing PRODUCT 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
1077912 308 Finland See Plans and Pricing
>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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