You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
McKinsey
Dow
Harvard Business School
Baxter

Last Updated: February 16, 2020

DrugPatentWatch Database Preview

Fesoterodine fumarate - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for fesoterodine fumarate and what is the scope of freedom to operate?

Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Zydus Pharms, and Pfizer, and is included in five NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fesoterodine fumarate has one hundred and thirty-one patent family members in thirty-three countries.

There are fifteen drug master file entries for fesoterodine fumarate. Five suppliers are listed for this compound. There are nine tentative approvals for this compound.

Recent Clinical Trials for fesoterodine fumarate

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

SponsorPhase
National Institute on Aging (NIA)N/A
University of North Carolina, Chapel HillN/A
Mayo ClinicPhase 4

See all fesoterodine fumarate clinical trials

Recent Litigation for fesoterodine fumarate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
PFIZER INC. v. DR. REDDYS LABORATORIES, LTD.2015-11-19
Pfizer Inc. v. Dr. Reddy's Laboratories Ltd.2015-11-18

See all fesoterodine fumarate litigation

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

See all fesoterodine fumarate litigation

Generic filers with tentative approvals for FESOTERODINE FUMARATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial8MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial4MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial8MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for fesoterodine fumarate
(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 - 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
Toviaz (TN)
UNII-EOS72165S7
X5023
Paragraph IV (Patent) Challenges for FESOTERODINE FUMARATE
Tradename Dosage Ingredient NDA Submissiondate
TOVIAZ TABLET, EXTENDED RELEASE;ORAL fesoterodine fumarate 022030 2012-10-31

US Patents and Regulatory Information for fesoterodine fumarate

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 Y   Start Trial
Dr Reddys Labs Ltd FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204975-002 Aug 13, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204827-002 Dec 10, 2015 DISCN No 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
>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 fesoterodine fumarate

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   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 022030-002 Oct 31, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fesoterodine fumarate

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
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 SPC037/2007 Ireland   Start Trial SPC037/2007: 20080507, EXPIRES: 20220419
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Moodys
Merck
Baxter
Medtronic

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 verifification 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.