Orange Book product · Brand (NDA)

LOTEMAX SM

LOTEPREDNOL ETABONATE

Brand (NDA)NDA 208219TE ABRX BAUSCH AND LOMB INC

Feb 22, 2019

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 22, 2019
7 yr 5 mo ago
Today
Patent 11534395 expires
Listed drug product patent expiration.
Jan 26, 2036
in 9 yr 9 mo
Patent 12589069 expires
Listed drug product patent expiration.
Jan 26, 2036
in 9 yr 9 mo
Patent 10596107 expires
Listed drug product patent expiration.
Dec 23, 2036
in 10 yr 8 mo

Active ingredient

LOTEPREDNOL ETABONATE

Strength

0.38%

Dosage form

GEL

Route

OPHTHALMIC

TE code

Application

NDA 208219

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
11534395	Jan 26, 2036	in 9 yr 9 mo	ProductU-2764
12589069	Jan 26, 2036	in 9 yr 9 mo	ProductU-2764
10596107	Dec 23, 2036	in 10 yr 8 mo	ProductU-2764