Orange Book product · Brand (NDA)

VESICARE LS

SOLIFENACIN SUCCINATE

Brand (NDA)NDA 209529DISCN ASTELLAS

May 26, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 26, 2020
6 yr 2 mo ago
Today
Patent 9918970 expires
Listed drug product patent expiration.
May 18, 2031
in 5 yr

Active ingredient

SOLIFENACIN SUCCINATE

Strength

1MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 209529

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9918970	May 18, 2031	in 5 yr	Product