Viewing data from:

TOVIAZ

NDA

FESOTERODINE FUMARATE | N022030 | PFIZER INC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (3)TodayPED (+6 mo)

2027

2028

Today

7807715

Dec. 7, 2027

8088398

Dec. 7, 2027

8501723

Dec. 7, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Torrent Pharmaceuticals Limited et al 1:2017cv00112	D. Del.	2017-02-02	Terminated 2017-09-06	—
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	—
Pfizer Inc. et al v. Wockhardt Bio AG et al 1:2013cv01387 5 patentsANDA 204987fesoterodine fumarate	D. Del.	2013-08-02	Terminated 2015-06-03	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

46 trials from ClinicalTrials.gov, 40 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years NCT00857896	Phase 2	Completed	Pfizer	21	2009-03 → 2010-12
Fall Prevention in Older Adults With OAB NCT03946124	Phase 4	Completed	University of Pennsylvania	74	2015-07-25 → 2017-07-19
A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects NCT00902681	Phase 1	Completed	Pfizer	36	2009-06 → 2009-08
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.NCT00611026	Phase 3	Completed	Pfizer	2,417	2008-02 → 2009-10
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency NCT00911937	Phase 4	Completed	Pfizer	963	2009-08 → 2011-09
Fesoterodine "add-on" Male Overactive Bladder Study NCT00546637	Phase 3	Completed	Pfizer	947	2007-11 → 2009-02
UK Study Assessing Flexible Dose Fesoterodine in Adults NCT00806494	Phase 4	Completed	Pfizer	331	2009-02 → 2010-01
Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder NCT01578304	Phase 4	Completed	LG Life Sciences	207	2010-12 → 2011-10
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.NCT01286454	Phase 1	Completed	Pfizer	20	2010-12 → 2011-03
Phase1, Single Dose, Crossover Study to Determine Bioequivalence NCT00786240	Phase 1	Completed	Pfizer	37	2009-01 → 2009-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$9.26

per ea

Lowest NADAC/Unit

$9.26

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00069024430TOVIAZ ER 8 MG TABLET	$9.26	EA	Brand	$0.8272	2026-06-17
00069024230TOVIAZ ER 4 MG TABLET	$9.26	EA	Brand	$0.8333	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$215.15

Highest Price

$288.48

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-0244-30TOVIAZ 8MG TAB	$288.48	FSS	Pfizer Inc.	06/30/2029
00069-0244-30TOVIAZ 8MG TAB	$216.36	Big4	Pfizer Inc.	06/30/2029
00069-0242-30TOVIAZ 4MG TAB	$288.48	FSS	Pfizer Inc.	06/30/2029
00069-0242-30TOVIAZ 4MG TAB	$215.15	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Toviaz (2024)

Total Spending

$2.6M

Total Claims

6,052

Beneficiaries

1,675

Avg Cost/Unit

$8.96

Spending Trend

$168.5M(2019)→$181.0M(2020)→$162.8M(2021)→$107.7M(2022)→$8.5M(2023)→$2.6M(2024)

YoY Change:-24.3%

5yr CAGR:-6.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Feb 29, 2024	SUPPL -23	View Letter (PDF)
Feb 29, 2024	SUPPL -22	View Letter (PDF)
Jun 22, 2021	SUPPL -19	View Letter (PDF)
Nov 15, 2017	SUPPL -14	View Letter (PDF)
Aug 3, 2012	SUPPL -9	View Letter (PDF)
Jan 3, 2012	SUPPL -8	View Letter (PDF)
Nov 3, 2011	SUPPL -6	View Letter (PDF)
Feb 14, 2011	SUPPL -7	View Letter (PDF)
Apr 8, 2010	SUPPL -4	View Letter (PDF)
Nov 7, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4MG

RLDAB

3 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 31, 2008

Patents (3) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7807715	Jun 7, 2027PED: Dec 7, 2027	PED	—	Yes		—
8088398	Jun 7, 2027PED: Dec 7, 2027	PED	—	Yes		—
8501723	Jun 7, 2027PED: Dec 7, 2027	PED	—	Yes	—	—

#002 — 8MG

RLDAB

3 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 31, 2008