Solifenacin succinate - Generic Drug Details

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What are the generic sources for solifenacin succinate and what is the scope of freedom to operate?

Solifenacin succinate is the generic ingredient in three branded drugs marketed by Astellas, Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma, Austarpharma, Breckenridge, Chartwell Rx, Cipla, Glenmark Pharms, Lannett Co Inc, Macleods Pharms Ltd, MSN, Qilu, Rising, Sciegen Pharms Inc, Strides Pharma, Sunshine, Teva Pharms Usa, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Solifenacin succinate has twenty-three patent family members in twenty-one countries.

There are twenty-nine drug master file entries for solifenacin succinate. Twenty-seven suppliers are listed for this compound.

Summary for solifenacin succinate

International Patents:	23
US Patents:	1
Tradenames:	3
Applicants:	25
NDAs:	26
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	58
Patent Applications:	4,502
Drug Prices:	Drug price trends for solifenacin succinate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for solifenacin succinate
What excipients (inactive ingredients) are in solifenacin succinate?	solifenacin succinate excipients list
DailyMed Link:	solifenacin succinate at DailyMed

See drug prices for solifenacin succinate

Recent Clinical Trials for solifenacin succinate

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

Sponsor	Phase
Shanghai University of Traditional Chinese Medicine	N/A
Longhua Hospital	N/A
Hikma Pharma	Phase 1

See all solifenacin succinate clinical trials

Pharmacology for solifenacin succinate

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for solifenacin succinate

Muscarinic Antagonists
Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for solifenacin succinate

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

Paragraph IV (Patent) Challenges for SOLIFENACIN SUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VESICARE LS	Oral Suspension	solifenacin succinate	1 mg/mL	209529	1	2021-05-27
VESICARE	Tablets	solifenacin succinate	5 mg and 10 mg	021518	1	2009-04-08

US Patents and Regulatory Information for solifenacin succinate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajanta Pharma Ltd	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	205483-002	May 20, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	209239-001	May 20, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	212214-001	Sep 26, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	209719-002	May 20, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	210224-001	May 20, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	209719-001	May 20, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	204374-002	Feb 20, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for solifenacin succinate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-001	Nov 19, 2004	⤷ Sign Up	⤷ Sign Up
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for solifenacin succinate

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Country	Patent Number	Title	Estimated Expiration
Canada	2799942	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA SOLIFENACINE (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN)	⤷ Sign Up
Serbia	55044	FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI SOLIFENACIN (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN)	⤷ Sign Up
European Patent Office	2572717	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA SOLIFÉNACINE (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN)	⤷ Sign Up
Cyprus	1117816		⤷ Sign Up
Eurasian Patent Organization	201291276	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СОЛИФЕНАЦИН	⤷ Sign Up
South Korea	20130093010	PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN	⤷ Sign Up
Mexico	2012013328	COMPOSICION FARMACEUTICA QUE CONTIENE SOLIFENACINA. (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for solifenacin succinate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0801067	04C0032	France	⤷ Sign Up	PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
0801067	C00801067/01	Switzerland	⤷ Sign Up	PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
0801067	SPC/GB04/029	United Kingdom	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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