Orange Book product · Brand (NDA)

ACUVUE THERAVISION WITH KETOTIFEN

KETOTIFEN FUMARATE

Brand (NDA)NDA 022388DISCN JOHNSON JOHNSON VISN

Feb 25, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 25, 2022
4 yr 5 mo ago
Today
Patent 9474746 expires
Listed drug product patent expiration.
Mar 27, 2028
in 1 yr 10 mo
Patent 9962376 expires
Listed drug product patent expiration.
Jun 27, 2030
in 4 yr 1 mo

Active ingredient

KETOTIFEN FUMARATE

Strength

EQ 19MCG BASE

Dosage form

DRUG-ELUTING CONTACT LENS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 022388

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
9474746	Mar 27, 2028	in 1 yr 10 mo	Product
9962376	Jun 27, 2030	in 4 yr 1 mo	Product