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FDA Orange Book · active-ingredient family

Fesoterodine fumarate

Fesoterodine fumarate is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TOVIAZ · NDA 022030

1

Brand (NDA)

11

Generics (ANDA)

6

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, extended release

ProductApplicantApplicationTEApproved
TOVIAZRLD×2PFIZERNDA 022030ABOct 31, 2008

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
FESOTERODINE FUMARATE×2HETERO LABS LTD VANDA 204792ABJan 09, 2024
FESOTERODINE FUMARATE×2CHARTWELL RXANDA 204983—Jan 05, 2023
FESOTERODINE FUMARATE×2ACCORD HLTHCAREANDA 205012—Jan 04, 2023
FESOTERODINE FUMARATE×2ACTAVIS LABS FL INCANDA 204868—Jan 04, 2023
FESOTERODINE FUMARATE×2ALEMBICANDA 204973ABJan 04, 2023
FESOTERODINE FUMARATE×2AMNEAL PHARMS NYANDA 205002ABJan 04, 2023
FESOTERODINE FUMARATE×2ANI PHARMSANDA 204504—Jan 04, 2023
FESOTERODINE FUMARATE×2DR REDDYSANDA 204975ABAug 13, 2019
FESOTERODINE FUMARATE×2ZYDUS PHARMSANDA 204946ABOct 03, 2017
FESOTERODINE FUMARATE×2AUROBINDO PHARMAANDA 205007ABFeb 17, 2017
FESOTERODINE FUMARATE×2ALKEM LABS LTDANDA 204827ABDec 10, 2015

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8088398Jun 07, 2027in 1 yr
ProductU-913
7807715Jun 07, 2027in 1 yr
ProductU-913
8501723Jun 07, 2027in 1 yr
Product
7807715*PEDDec 07, 2027in 1 yr 6 mo
8088398*PEDDec 07, 2027in 1 yr 6 mo
8501723*PEDDec 07, 2027in 1 yr 6 mo

Fesoterodine fumarate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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