➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:


Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209529

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 209529 describes VESICARE LS, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. Additional details are available on the VESICARE LS profile page.

The generic ingredient in VESICARE LS is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 209529
Ingredient:solifenacin succinate
Pharmacology for NDA: 209529
Medical Subject Heading (MeSH) Categories for 209529
Suppliers and Packaging for NDA: 209529
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VESICARE LS solifenacin succinate SUSPENSION;ORAL 209529 NDA Astellas Pharma US, Inc. 51248-250 51248-250-99 1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) > 150 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength1MG/ML
Approval Date:May 26, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 26, 2023
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Nov 26, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School

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 verification 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.