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Colorcon
US Army
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Argus Health
Boehringer Ingelheim
Moodys
Express Scripts
US Department of Justice
Fuji

Generated: August 15, 2018

DrugPatentWatch Database Preview

Fesoterodine fumarate - Generic Drug Details

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

Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Zydus Pharms Usa Inc, and Pfizer, and is included in four 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 fourteen drug master file entries for fesoterodine fumarate. Six suppliers are listed for this compound. There are nine tentative approvals for this compound.

Synonyms for fesoterodine fumarate
(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
AK323629
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
MFCD12756004
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
SCHEMBL1993632
SCHEMBL814971
SMR002544691
SPM 8272
SPM 907
SPM-8272
SPM-907
Toviaz
Toviaz (TN)
UNII-EOS72165S7
X5023
Tentative approvals for FESOTERODINE FUMARATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial4MGTABLET, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial8MGTABLET, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial8MGTABLET, EXTENDED RELEASE;ORAL

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 022030-002 Oct 31, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Zydus Pharms Usa Inc FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204946-001 Oct 3, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Alkem Labs Ltd FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204827-002 Dec 10, 2015 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for fesoterodine fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,713,464 Derivatives of 3,3-diphenylpropylamines ➤ Try a Free Trial
7,230,030 Derivatives of 3,3-diphenylpropylamines ➤ Try a Free Trial
9,364,541 Pharmaceutical compositions comprising Fesoterodine ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for fesoterodine fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB07/053 United Kingdom ➤ Try a Free 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.
365 Luxembourg ➤ Try a Free Trial 91365, EXPIRES: 20220420
2007008,C1230209 Lithuania ➤ Try a Free Trial PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
C0050 France ➤ Try a Free 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
8 Finland ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Deloitte
Mallinckrodt
Cerilliant
QuintilesIMS
McKesson
Chubb
UBS

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