Viewing data from:

VESICARE

NDA

SOLIFENACIN SUCCINATE | N021518 | ASTELLAS PHARMA US INC

2 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Astellas Pharma Inc. et al v. Aurobindo Pharma Limited 1:2018cv00932	D. Del.	2018-06-25	Terminated 2018-09-24	—

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

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Reguliance LLC on behalf of Intas Third Party Sales... FDA-2023-P-4326 · 12 docket documents Reguliance LLC, on behalf of Intas Third Party Sales 2005, S.L., filed this ANDA suitability petition pursuant to section 505(j)(2)(C) requesting that the FDA determine that Solifenacin Succinate 5 mg and 10 mg orally disintegrating tablets are suitable for submission in an Abbreviated New Drug Appl	Suitability	2023-10-03	Denied	Intas Third Party Sales 2005, S.L.
Attachment 2 Vesicare LS Solifenacin Succinate Oral Suspension re Suitability... FDA-2021-P-0567 · 5 docket documents M A Pharmaceutical Consulting Inc filed a citizen petition requesting FDA confirmation of suitability regarding Vesicare LS (solifenacin succinate oral suspension), seeking regulatory acknowledgment that the formulation is suitable for approval and commercialization under applicable NDA procedures.	Suitability	2021-07-07	Open	M A Pharmaceutical Consulting Inc
Citizen Petition from Reguliance LLC on behalf of INTAS Pharmaceuticals, Ltd. FDA-2019-P-4645 · 11 docket documents Reguliance LLC on behalf of INTAS Pharmaceuticals, Ltd. filed an ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Solifenacin Succinate 5 mg and 10 mg orally disintegrating tablets are suitable for submission in	Other	2019-10-04	Withdrawn	INTAS Pharmaceuticals, Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

108 trials from ClinicalTrials.gov — 1 recruiting, 82 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients NCT01530373	Phase 2	Recruiting	University of Arkansas	110	2012-02 → 2028-09
A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment NCT01318837	Phase 4	Completed	Astellas Pharma Inc	100	2010-04 → 2011-09
Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency NCT00979472	Phase 4	Completed	Asan Medical Center	291	2009-04 → 2010-06
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)NCT00337558	Phase 4	Completed	Astellas Pharma Inc	643	2006-05 → 2007-05
The Effect of Solifenacin on Post Void Dribbling in Women NCT01470001	N/A	Completed	University of Wisconsin, Madison	118	2011-11 → 2015-09
The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)NCT01533597	Phase 4	Completed	Soonchunhyang University Hospital	70	2010-12 → 2014-02
A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation NCT01406158	Phase 1	Completed	Astellas Pharma Inc	24	2011-05 → 2011-07
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels NCT02010944	Phase 1	Completed	Astellas Pharma Europe B.V.	72	2012-09 → 2012-11
A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.NCT00333112	Phase 4	Completed	Astellas Pharma Inc	398	2006-05 → 2007-01
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder NCT01340027	Phase 2	Completed	Astellas Pharma Europe B.V.	1,307	2011-03-29 → 2012-06-28

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

$12.30

per ea

Lowest NADAC/Unit

$12.28

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51248015101VESICARE 10 MG TABLET	$12.30	EA	Brand	$0.1832	2026-06-17
51248015001VESICARE 5 MG TABLET	$12.28	EA	Brand	$0.1729	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 | 2 NDCs (2 FSS)

Lowest Price

$281.80

Highest Price

$281.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
51248-0150-01VESICARE 5MG TAB	$281.80	FSS	Astellas Pharma U.S., Inc.	09/29/2026
51248-0151-01VESICARE 10MG TAB	$281.85	FSS	Astellas Pharma U.S., Inc.	09/29/2026

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

Medicare Part D Spending

CMS annual spending data for Vesicare (2024)

Total Spending

$4.0M

Total Claims

5,390

Beneficiaries

1,363

Avg Cost/Unit

$12.21

Spending Trend

$360.9M(2019)→$24.3M(2020)→$11.9M(2021)→$8.1M(2022)→$5.7M(2023)→$4.0M(2024)

YoY Change:-5.5%

5yr CAGR:+0.6%

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

API Supply Chain25 active DMFs7 inactive

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

TAPI NL BVSOLIFENACIN SUCCINATE

DMF 221732008

DR REDDYS LABORATORIES LTDSOLIFENACIN SUCCINATE

DMF 222632008

ALIVUS LIFE SCIENCES LTDSOLIFENACIN SUCCINATE

DMF 224182009

MSN LABORATORIES PRIVATE LTDSOLIFENACIN SUCCINATE [ROUTE CODE - "SF"]

DMF 237472010

UNIMARK REMEDIES LTDSOLIFENACIN SUCCINATE

DMF 239652010

INTERQUIM SASOLIFENACIN SUCCINATE

DMF 241542010

MEGAFINE PHARMA P LTDSOLIFENACIN SUCCINATE

DMF 241862010

JUBILANT BIOSYS LTDSOLIFENACIN SUCCINATE

DMF 247652011

HETERO DRUGS LTDSOLIFENACIN SUCCINATE

DMF 248712011

ALEMBIC PHARMACEUTICALS LTDSOLIFENACIN SUCCINATE

DMF 258872012

APITORIA PHARMA PRIVATE LTDSOLIFENACIN SUCCINATE

DMF 275502013

WEIHAI DISU PHARMACEUTICAL CO LTDSOLIFENACIN SUCCINATE

DMF 283732015

ISOCHEM SASSOLIFENACIN SUCCINATE

DMF 288702014

CIPLA LTDSOLIFENACIN SUCCINATE

DMF 294892015

QILU PHARMACEUTICAL CO LTDSOLIFENACIN SUCCINATE (NON-STERILE, API)

DMF 295032015

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)SOLIFENACIN SUCCINATE

DMF 295812015

UNICHEM LABORATORIES LTDSOLIFENACIN SUCCINATE

DMF 303832016

RAKS PHARMA PVT LTDSOLIFENACIN SUCCINATE

DMF 305412016

DELMAR CHEMICALS INCSOLIFENACIN SUCCINATE

DMF 306712016

OPTIMUS DRUGS PRIVATE LTDSOLIFENACIN SUCCINATE

DMF 309652016

MICRO LABS LTDSOLIFENACIN SUCCINATE

DMF 314592017

AMOLI ORGANICS PVT LTDSOLIFENACIN SUCCINATE

DMF 317892017

NOVUGEN PHARMA MALAYSIA SDN BHDSOLIFENACIN SUCCINATE

DMF 333062019

RUYUAN HEC PHARM CO LTDSOLIFENACIN SUCCINATE NON-STERILE BULK DRUG SUBSTANCE

DMF 351402020

SMS PHARMACEUTICALS LTDSOLIFENACIN SUCCINATE

DMF 361332022

CADILA HEALTHCARE LTDInactiveSOLIFENACIN SUCCINATE

DMF 236892010

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveSOLIFENACIN SUCCINATE

DMF 240442010

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveSOLIFENACIN SUCCINATE

DMF 244472010

PHF SAInactiveSOLIFENACIN SUCCINATE

DMF 254882011

CRYSTAL PHARMA LTDInactiveSOLIFENACIN SUCCINATE

DMF 261252012

FIS FABBRICA ITALIANA SINTETICI SPAInactiveSOLIFENACIN SUCCINATE

DMF 261902012

KYONGBO PHARMACEUTICAL CO LTDInactiveSOLIFENACIN SUCCINATE

DMF 289772015

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
May 28, 2020	SUPPL -17	View Letter (PDF)
May 2, 2019	SUPPL -18	View Letter (PDF)
Oct 11, 2013	SUPPL -16	View Letter (PDF)
Apr 1, 2013	SUPPL -15	View Letter (PDF)
Aug 6, 2012	SUPPL -14	View Letter (PDF)
Jul 17, 2012	SUPPL -13	View Letter (PDF)
Jun 12, 2012	SUPPL -11	View Letter (PDF)
Jan 19, 2012	SUPPL -12	View Letter (PDF)
Mar 14, 2011	SUPPL -10	View Letter (PDF)
Jul 14, 2010	SUPPL -8	View Letter (PDF)
Nov 21, 2008	SUPPL -7	View Letter (PDF)
Oct 30, 2008	SUPPL -6	View Letter (PDF)
Feb 14, 2008	SUPPL -4	View Letter (PDF)
Jul 24, 2007	SUPPL -3	View Letter (PDF)
Dec 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 19, 2004

No patent or exclusivity listings for this strength.

#002 — 10MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 19, 2004