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Last Updated: December 12, 2019

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TOVIAZ Drug Profile

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Which patents cover Toviaz, and when can generic versions of Toviaz launch?

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

This drug has one hundred and thirty-one patent family members in thirty-three 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 launched as fesoterodine fumarate by AUROBINDO PHARMA LTD on December 12th, 2019.

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

See all TOVIAZ clinical trials

Recent Litigation for TOVIAZ

Identify potential future generic entrants

District Court Litigation
Case NameDate
PFIZER INC. v. DR. REDDYS LABORATORIES, LTD.2015-11-19
Pfizer Inc. v. Dr. Reddy's Laboratories Ltd.2015-11-18
Pfizer Inc. v. Mylan Pharmaceuticals Inc.2015-01-23

See all TOVIAZ litigation

PTAB Litigation
PetitionerDate
Alembic Pharmaceuticals Limited2016-08-22
Amerigen Pharmaceuticals Limited2016-08-22
Torrent Pharmaceuticals Limited2016-08-18

See all TOVIAZ litigation

Synonyms for TOVIAZ
(E)-but-2-enedioic acid,[2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate
(E)-but-2-enedioic acid;[2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate
(R)-Fesoterodine fumarate
[2-[(1R)-3-(diisopropylamino)-1-phenyl-propyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate; fumaric acid
2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl 2-methylpropanoate hydrogen (2E)-butenedioate (salt)
2-((1R)-3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl isobutyrate
286930-03-8
930F038
ABP000771
AC-3486
AKOS005146248
AKOS015855886
AN-490
AT-36463
BC244477
BCP9000682
BCPP000231
C26H37NO3.C4H4O4
CHEMBL1201765
CS-0822
D08923
EOS72165S7
Fesoterodine fumarate
Fesoterodine fumarate - Toviaz
Fesoterodine fumarate (JAN/USP)
Fesoterodine fumarate [USAN:JAN]
Fesoterodine fumarate [USAN]
Fesoterodine fumarate, Toviaz
Fesoterodine fumarate/
Fesoterodine fumarate|286930-03-8
Fesoterodine maleate
fesoterodine; fumaric acid
Fesoterodinefumarate
Fesoterodinefumarate;(R)-Fesoterodine Fumarate;2-Methylpropanoic Acid 2-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl Ester (2E)-2-Butenedioate
HY-A0030
KB-51873
KS-1298
LS-184117
MLS003915638
MolPort-006-394-111
MWHXMIASLKXGBU-RNCYCKTQSA-N
PF-00695838
Propanoic acid, 2-methyl-, 2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl ester, (2E)-2-butenedioate (1:1) (salt)
s2240
SB19323
SCHEMBL1993632
SCHEMBL814971
SMR002544691
SPM 8272
SPM 907
SPM-8272
SPM-907
Toviaz (TN)
UNII-EOS72165S7
X5023
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 022030-001 Oct 31, 2008 AB RX Yes No   Start Trial   Start Trial   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 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 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 022030-002 Oct 31, 2008 AB RX Yes Yes   Start Trial   Start Trial Y 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 022030-002 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 022030-002 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 022030-001 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 SZ 47/2007 Austria   Start Trial PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
1077912 91365 Luxembourg   Start Trial 91365, EXPIRES: 20220420
1230209 PA2007008 Lithuania   Start Trial PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
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
1077912 CA 2007 00046 Denmark   Start Trial PRODUCT NAME: FESOTERODIN, FUMARAT
1077912 SPC037/2007 Ireland   Start Trial SPC037/2007: 20080507, EXPIRES: 20220419
1077912 C01077912/01 Switzerland   Start Trial PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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