Orange Book product · Brand (NDA)

LEXETTE

HALOBETASOL PROPIONATE

Brand (NDA)NDA 210566DISCN MAYNE PHARMA

May 24, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 24, 2018
8 yr 2 mo ago
Today
Patent 10857159 expires
Listed drug product patent expiration.
Nov 30, 2036
in 10 yr 7 mo
Patent 11020407 expires
Listed drug product patent expiration.
Nov 30, 2036
in 10 yr 7 mo
Patent 10857159*PED expires
Listed listed patent expiration.
May 30, 2037
in 11 yr 1 mo

Active ingredient

HALOBETASOL PROPIONATE

Strength

0.05%

Dosage form

AEROSOL, FOAM

Route

TOPICAL

TE code

Not listed

Application

NDA 210566

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
10857159	Nov 30, 2036	in 10 yr 7 mo	Product
11020407	Nov 30, 2036	in 10 yr 7 mo	ProductU-3143
10857159*PED	May 30, 2037	in 11 yr 1 mo