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Last Updated: January 27, 2023

Fesoterodine fumarate - Generic Drug Details


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What are the generic drug sources for fesoterodine fumarate and what is the scope of patent protection?

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

Fesoterodine fumarate has seventy-eight patent family members in twenty-nine countries.

There are fourteen drug master file entries for fesoterodine fumarate. Eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for fesoterodine fumarate
Recent Clinical Trials for fesoterodine fumarate

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

SponsorPhase
University of North Carolina, Chapel HillPhase 3
National Institute on Aging (NIA)Phase 3
Mayo ClinicPhase 4

See all fesoterodine fumarate clinical trials

Generic filers with tentative approvals for FESOTERODINE FUMARATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing8MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing4MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing8MGTABLET, 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.

Paragraph IV (Patent) Challenges for FESOTERODINE FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TOVIAZ Extended-release Tablets fesoterodine fumarate 4 mg and 8 mg 022030 16 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Dr Reddys FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204975-002 Aug 13, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204827-002 Dec 10, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aurobindo Pharma FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 205007-002 Feb 17, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fesoterodine fumarate

Country Patent Number Title Estimated Expiration
European Patent Office 1230209 SELS STABLES DE NOUVEAUX DERIVES DE 3,3-DIPHENYLPROPYLAMINES (STABLE SALTS OF NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES) See Plans and Pricing
Japan 2010180243 STABLE SALT OF NOVEL DERIVATIVE OF 3,3-DIPHENYLPROPYLAMINES See Plans and Pricing
Israel 149567 STABLE SALTS OF NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES See Plans and Pricing
Japan 2007137895 STABLE SALT OF NEW DERIVATIVE OF 3, 3-DIPHENYL PROPYLAMINES See Plans and Pricing
China 1390194 See Plans and Pricing
Hong Kong 1095736 See Plans and Pricing
Denmark 1690536 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fesoterodine fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1481964 C 2007 098 Romania See Plans and Pricing 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 SPC/GB07/053 United Kingdom See Plans and Pricing 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.
1230209 PA2007008 Lithuania See Plans and Pricing PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912 07C0050 France See Plans and Pricing 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 SZ 47/2007 Austria See Plans and Pricing PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
1230209 PA2007008,C1230209 Lithuania See Plans and Pricing PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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