Orange Book product · Brand (NDA)

BRYHALI

HALOBETASOL PROPIONATE

Brand (NDA)NDA 209355RX BAUSCH

Nov 06, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 06, 2018
7 yr 9 mo ago
Today
Patent 10478502 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 11839656 expires
Listed method-of-use patent (U-2625) expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 11957753 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 11986527 expires
Listed method-of-use patent (U-2625) expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 12076403 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 8809307 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo

Active ingredient

HALOBETASOL PROPIONATE

Strength

0.01%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

NDA 209355

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
10478502	Nov 02, 2031	in 5 yr 5 mo	ProductU-2625
11839656	Nov 02, 2031	in 5 yr 5 mo	U-2625
11957753	Nov 02, 2031	in 5 yr 5 mo	Product
11986527	Nov 02, 2031	in 5 yr 5 mo	U-2625
12076403	Nov 02, 2031	in 5 yr 5 mo	Product
8809307	Nov 02, 2031	in 5 yr 5 mo	Product