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Solifenacin succinate - Generic Drug Details

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Solifenacin succinate is the generic ingredient in two branded drugs marketed by Astellas and Teva Pharms Usa, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-one patent family members in twenty-two countries.

There are twenty-seven drug master file entries for solifenacin succinate. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: solifenacin succinate

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list27
Suppliers / Packaging: see list4
Therapeutic Class:Genitourinary Agents
Drug Prices:see low prices

Pharmacology for Ingredient: solifenacin succinate

Tentative approvals for SOLIFENACIN SUCCINATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL5MG
<disabled><disabled>TABLET;ORAL10MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
VESICARE
solifenacin succinate
TABLET;ORAL021518-001Nov 19, 2004RXNo6,017,927► subscribeYY ► subscribe
Teva Pharms Usa
SOLIFENACIN SUCCINATE
solifenacin succinate
TABLET;ORAL091464-001Apr 2, 2014RXNo► subscribe► subscribe
Astellas
VESICARE
solifenacin succinate
TABLET;ORAL021518-002Nov 19, 2004RXYes6,017,927► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: solifenacin succinate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,174,896 Quinuclidine derivatives and medicinal composition thereof► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: solifenacin succinate

Country Document Number Estimated Expiration
Australia695616► subscribe
Poland321019► subscribe
Norway318026► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SOLIFENACIN SUCCINATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0032France► subscribePRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
C014/2004Ireland► subscribeSPC014/2004: 20050803, EXPIRES: 20181215
133Luxembourg► subscribe91133, EXPIRES: 20181118
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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