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Last Updated: July 7, 2020

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

US ANDA Litigation and Generic Entry Outlook for Toviaz

A generic version of TOVIAZ was approved as fesoterodine fumarate by AUROBINDO PHARMA LTD on February 17th, 2017.

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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

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SponsorPhase
University of AlbertaPhase 2
International Collaboration On Repair Discoveries (ICORD)Phase 2
Vancouver Coastal HealthPhase 2

See all TOVIAZ clinical trials

Paragraph IV (Patent) Challenges for TOVIAZ
Tradename Dosage Ingredient NDA Submissiondate
TOVIAZ TABLET, EXTENDED RELEASE;ORAL fesoterodine fumarate 022030 2012-10-31

US Patents and Regulatory Information for TOVIAZ

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   Start Trial   Start Trial Y   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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 022030-002 Oct 31, 2008   Start Trial   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008   Start Trial   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008   Start Trial   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008   Start Trial   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008   Start Trial   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008   Start Trial   Start Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TOVIAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1077912 CA 2007 00046 Denmark   Start Trial PRODUCT NAME: FESOTERODIN, FUMARAT
1077912 SZ 47/2007 Austria   Start Trial PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
1077912 07C0050 France   Start Trial 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
1481964 C 2007 098 Romania   Start 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 [...]
1077912 C01077912/01 Switzerland   Start Trial PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008
1077912 308 Finland   Start Trial
1077912 SPC/GB07/053 United Kingdom   Start Trial 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.
>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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