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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

2 cases 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	—
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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Toviaz (2023)

Total Spending

$8.5M

Total Claims

17,729

Beneficiaries

7,230

Avg Cost/Unit

$11.84

Spending Trend

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

YoY Change:-8.2%

5yr CAGR:+1.6%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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