Is there a generic for Fesoterodine fumarate?

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Fesoterodine fumarate, referencing the brand TOVIAZ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fesoterodine fumarate?

TOVIAZ (NDA 022030, PFIZER) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Fesoterodine fumarate?

The Orange Book lists 6 patents against Fesoterodine fumarate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Fesoterodine fumarate are approved?

Fesoterodine fumarate is approved in the following dosage form: tablet, extended release.

FDA Orange Book · active-ingredient family

Fesoterodine fumarate

Fesoterodine fumarate: 1 brand, 11 generics; first approved Oct 31, 2008; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 11 ANDA applications approved.

Earliest patent expiry Jun 07, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jun 07, 2027

in 10 mo

Brand (NDA) products

Originator applications

TOVIAZRLD
PFIZERNDA 02203020082 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Generic (ANDA) products (11)

Abbreviated applications

FESOTERODINE FUMARATE
HETERO LABS LTD VANDA 20479220242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB
FESOTERODINE FUMARATE
CHARTWELL RXANDA 20498320232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Discontinued —
8MG TABLET, EXTENDED RELEASE ORAL Discontinued —
FESOTERODINE FUMARATE
ACCORD HLTHCAREANDA 20501220232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Discontinued —
8MG TABLET, EXTENDED RELEASE ORAL Discontinued —
FESOTERODINE FUMARATE
ACTAVIS LABS FL INCANDA 20486820232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Discontinued —
8MG TABLET, EXTENDED RELEASE ORAL Discontinued —
FESOTERODINE FUMARATE
ALEMBICANDA 20497320232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB
FESOTERODINE FUMARATE
AMNEAL PHARMS NYANDA 20500220232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB
FESOTERODINE FUMARATE
ANI PHARMSANDA 20450420232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Discontinued —
8MG TABLET, EXTENDED RELEASE ORAL Discontinued —
FESOTERODINE FUMARATE
DR REDDYSANDA 20497520192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB
FESOTERODINE FUMARATE
ZYDUS PHARMSANDA 20494620172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB
FESOTERODINE FUMARATE
AUROBINDO PHARMAANDA 20500720172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB
FESOTERODINE FUMARATE
ALKEM LABS LTDANDA 20482720152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG TABLET, EXTENDED RELEASE ORAL Rx AB
8MG TABLET, EXTENDED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
8MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
8MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
8MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
8MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
8MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8088398	Jun 07, 2027	in 10 mo	ProductU-913
7807715	Jun 07, 2027	in 10 mo	ProductU-913
8501723	Jun 07, 2027	in 10 mo	Product
7807715*PED	Dec 07, 2027	in 1 yr 4 mo
8088398*PED	Dec 07, 2027	in 1 yr 4 mo
8501723*PED	Dec 07, 2027	in 1 yr 4 mo

Approval history

FDA approval span

First approval

Oct 31, 2008

18 yr 1 mo ago

Most recent approval

Jan 09, 2024

2 yr 8 mo ago

Approvals span 2008–2024 across 12 FDA applications.

Brand (NDA) 18%

Generic (ANDA) 1192%

Fesoterodine fumarate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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