You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 18, 2024

TOVIAZ Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 three patents protecting this drug and one Paragraph IV challenge.

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.

  Try a Trial

Drug patent expirations by year for TOVIAZ
Drug Prices for TOVIAZ

See drug prices for TOVIAZ

Drug Sales Revenue Trends for TOVIAZ

See drug sales revenues for TOVIAZ

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
International Collaboration On Repair Discoveries (ICORD)Phase 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 three US patents and two FDA Regulatory Exclusivities.

Patents protecting TOVIAZ

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 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 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 ⤷  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 022030-002 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
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
>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
World Intellectual Property Organization (WIPO) 9958478 ⤷  Try a Trial
Japan 2007137895 STABLE SALT OF NEW DERIVATIVE OF 3, 3-DIPHENYL PROPYLAMINES ⤷  Try a Trial
Poland 195581 ⤷  Try a Trial
Germany 19955190 ⤷  Try a Trial
Germany 122007000065 ⤷  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
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 [...]
1077912 SPC037/2007 Ireland ⤷  Try a Trial SPC037/2007: 20080507, EXPIRES: 20220419
1077912 C01077912/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008
1077912 07C0050 France ⤷  Try a 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
1077912 SPC/GB07/053 United Kingdom ⤷  Try a 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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.