Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Fesoterodine fumarate - Generic Drug Details

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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
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 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   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   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
>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 022030-002 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
>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 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 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
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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