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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Chubb
McKesson
Farmers Insurance
Chinese Patent Office
Boehringer Ingelheim
Baxter
Queensland Health
Harvard Business School
AstraZeneca

Generated: February 20, 2018

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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 thirteen drug master file entries for fesoterodine fumarate. Seven suppliers are listed for this compound. There are nine tentative approvals for this compound.
Summary for fesoterodine fumarate
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 022030-001 Oct 31, 2008 AB RX Yes No ➤ 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 204946-002 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 022030-001 Oct 31, 2008 AB RX Yes No ➤ 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
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
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
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
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No ➤ 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
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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International Patents for fesoterodine fumarate

Supplementary Protection Certificates for fesoterodine fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8 Finland ➤ Try a Free Trial
47/2007 Austria ➤ Try a Free Trial PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
C/GB07/053 United Kingdom ➤ Try a Free Trial PRODUCT NAME: FESOTERODINE AND ITS SALTS WITH PHYSIOLOGICALLY ACCEPTABLE ACIDS, INCLUDING FUMARIC ACID; REGISTERED: UK EU/1/07/386/001 20070420; UK EU/1/07/386/002 20070420; UK EU/1/07/386/003 20070420; UK EU/1/07/386/004 20070420; UK EU/1/07/386/005 20070420; UK EU/1/07/386/006 20070420; UK EU/1/07/386/007 20070420; UK EU/1/07/386/008 20070420; UK EU/1/07/386/009 20070420; UK EU/1/07/386/010 20070420
365 Luxembourg ➤ Try a Free Trial 91365, EXPIRES: 20220420
2007008 Lithuania ➤ Try a Free Trial PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
C037/2007 Ireland ➤ Try a Free Trial SPC037/2007: 20080507, EXPIRES: 20220419
2007 00046 Denmark ➤ Try a Free Trial PRODUCT NAME: FESOTERODIN, FUMARAT
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
1077912/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008
2007008,C1230209 Lithuania ➤ Try a Free Trial PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Chubb
Baxter
Cantor Fitzgerald
Boehringer Ingelheim
Teva
Deloitte
Johnson and Johnson
Accenture

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.

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