Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Mallinckrodt
Farmers Insurance
QuintilesIMS
Baxter
Julphar
Accenture
Cantor Fitzgerald
Merck

Generated: May 26, 2018

DrugPatentWatch Database Preview

Fesoterodine fumarate - Generic Drug Details

or, see our see our flat-rate plans

« Back to Dashboard

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. Seven 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
➤ Sign Up➤ Sign Up4MGTABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up8MGTABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up8MGTABLET, 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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 205007-002 Feb 17, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

Supplementary Protection Certificates for fesoterodine fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C037/2007 Ireland ➤ Sign Up SPC037/2007: 20080507, EXPIRES: 20220419
C/GB07/053 United Kingdom ➤ Sign Up 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.
2007008,C1230209 Lithuania ➤ Sign Up PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
2007 00046 Denmark ➤ Sign Up PRODUCT NAME: FESOTERODIN, FUMARAT
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Citi
Baxter
Accenture
Cantor Fitzgerald
Boehringer Ingelheim
Harvard Business School
Fuji
Chubb

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.