VESICARE LS Drug Patent Profile

Which patents cover Vesicare Ls, and what generic alternatives are available?

Vesicare Ls is a drug marketed by Astellas and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in twenty-two countries.

The generic ingredient in VESICARE LS is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vesicare Ls

A generic version of VESICARE LS was approved as solifenacin succinate by TEVA PHARMS USA on April 2^nd, 2014.

Summary for VESICARE LS

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	67
Patent Applications:	1,881
Drug Prices:	Drug price information for VESICARE LS
DailyMed Link:	VESICARE LS at DailyMed

See drug prices for VESICARE LS

Recent Clinical Trials for VESICARE LS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Genuine Research Center, Egypt	Phase 1
Hikma Pharma	Phase 1
Brigitte Schürch	Phase 4

See all VESICARE LS clinical trials

Pharmacology for VESICARE LS

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for VESICARE LS

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for VESICARE LS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VESICARE LS	Oral Suspension	solifenacin succinate	1 mg/mL	209529	1	2021-05-27

US Patents and Regulatory Information for VESICARE LS

VESICARE LS is protected by one US patents and two FDA Regulatory Exclusivities.

Patents protecting VESICARE LS

FDA Regulatory Exclusivity protecting VESICARE LS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes			Y
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes

International Patents for VESICARE LS

See the table below for patents covering VESICARE LS around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2572717
Japan	5831449
South Africa	201208762	PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN
Lithuania	2572717
South Korea	20130093010	PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN
Taiwan	201208684	Pharmaceutical composition comprising solifenacin
European Patent Office	2572717	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA SOLIFÉNACINE (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN)

Supplementary Protection Certificates for VESICARE LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0801067	SPC/GB04/029	United Kingdom		PRODUCT NAME: SOLIFENACIN AND/OR PHARMACEUTICALLY ACTIVE SALT THEREOF; REGISTERED: NL RVG 29151 20031216; NL RVG 29152 20031216; UK PL 00166/0197 20040816; UK PL 0016/0198 20040816
0801067	C00801067/01	Switzerland		PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
0801067	04C0032	France		PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216