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Last Updated: November 7, 2024

Fesoterodine fumarate - Generic Drug Details


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What are the generic 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 Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Zydus Pharms, and Pfizer, and is included in twelve NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for fesoterodine fumarate. Fifteen suppliers are listed for this compound. There are three 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)Phase 3
University of North Carolina, Chapel HillPhase 3
Mayo ClinicPhase 4

See all fesoterodine fumarate clinical trials

Generic filers with tentative approvals for FESOTERODINE FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up8MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up4MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up8MGTABLET, 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.

Anatomical Therapeutic Chemical (ATC) Classes for fesoterodine fumarate
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204792-002 Jan 9, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204827-001 Dec 10, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204975-001 Aug 13, 2019 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 ⤷  Sign Up
Zydus Pharms FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204946-002 Oct 3, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 ⤷  Sign Up ⤷  Sign Up
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 ⤷  Sign Up ⤷  Sign Up
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-002 Oct 31, 2008 ⤷  Sign Up ⤷  Sign Up
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 ⤷  Sign Up ⤷  Sign Up
Pfizer TOVIAZ fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 022030-001 Oct 31, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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