Orange Book product · Brand (NDA)

VUITY

PILOCARPINE HYDROCHLORIDE

Brand (NDA)NDA 214028DISCN ABBVIE

Oct 28, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 28, 2021
4 yr 9 mo ago
Exclusivity ends · D-187
New indication / change exclusivity (3 years)
Mar 28, 2026
3 mo ago
Today
Patent 10610518 expires
Listed method-of-use patent (U-3562) expiration.
Apr 24, 2039
in 13 yr
Patent 10610518 expires
Listed method-of-use patent (U-3561) expiration.
Apr 24, 2039
in 13 yr
Patent 10610518 expires
Listed method-of-use patent (U-3252) expiration.
Apr 24, 2039
in 13 yr
Patent 11285134 expires
Listed method-of-use patent (U-3561) expiration.
Apr 24, 2039
in 13 yr
Patent 11285134 expires
Listed method-of-use patent (U-3562) expiration.
Apr 24, 2039
in 13 yr
Patent 11285134 expires
Listed method-of-use patent (U-3252) expiration.
Apr 24, 2039
in 13 yr

Active ingredient

PILOCARPINE HYDROCHLORIDE

Strength

1.25%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 214028

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
10610518	Apr 24, 2039	in 13 yr	U-3562
10610518	Apr 24, 2039	in 13 yr	U-3561
10610518	Apr 24, 2039	in 13 yr	U-3252
11285134	Apr 24, 2039	in 13 yr	U-3561
11285134	Apr 24, 2039	in 13 yr	U-3562
11285134	Apr 24, 2039	in 13 yr	U-3252