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FESOTERODINE FUMARATE

ANDA

FESOTERODINE FUMARATE | A204975 | DR REDDYS LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TOVIAZ(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Dr. Reddy's Laboratories Ltd. et al 1:2015cv01067 5 patentsANDA 204975fesoterodine fumarate	D. Del.	2015-11-18	Terminated 2016-02-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.8333

per ea

Lowest NADAC/Unit

$0.8272

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
43598024730FESOTERODINE ER 4 MG TABLET	$0.8333	EA	Generic	—	2026-06-17
43598024830FESOTERODINE ER 8 MG TABLET	$0.8272	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain13 active DMFs2 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA FRANCIS SRLFESOTERODINE FUMARATE

DMF 250522011

ZYDUS LIFESCIENCES LTDFESOTERODINE FUMARATE

DMF 259162012

SUN PHARMACEUTICAL INDUSTRIES LTDFESOTERODINE FUMARATE

DMF 261732012

ALEMBIC PHARMACEUTICALS LTDFESOTERODINE FUMARATE

DMF 262412012

LUPIN MANUFACTURING SOLUTIONS LTDFESOTERODINE FUMARATE

DMF 262752012

SIGNA SA DE CVFESOTERODINE FUMARATE

DMF 263452012

MSN PHARMACHEM PRIVATE LTDFESOTERODINE FUMARATE [ROUTE CODE FF]

DMF 263702012

RAKS PHARMA PVT LTDFESOTERODINE FUMARATE

DMF 263922012

HETERO DRUGS LTDFESOTERODINE FUMARATE

DMF 264272012

INTAS PHARMACEUTICALS LTDFESOTERODINE FUMARATE

DMF 265032012

WOCKHARDT BIO AGFESOTERODINE FUMARATE

DMF 265072012

MAITHRI LABORATORIES PRIVATE LTDFESOTERODINE FUMARATE

DMF 332302018

AURORE LIFE SCIENCES PRIVATE LTDFESOTERODINE FUMARATE

DMF 356792021

LEK PHARMACEUTICALS DDInactiveFESOTERODINE FUMARATE

DMF 264912012

CHEMI SPAInactiveFESOTERODINE FUMARATE

DMF 264982012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 4MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 13, 2019

No patent or exclusivity listings for this strength.

#002 — 8MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 13, 2019