Orange Book product · Brand (NDA)

ACANYA

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Brand (NDA)NDA 050819TE ABRX BAUSCH

Oct 23, 2008

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 23, 2008
17 yr 11 mo ago
Today
Patent 10220049 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 10624918 expires
Listed method-of-use patent (U-916) expiration.
Jun 03, 2029
in 3 yr
Patent 8663699 expires
Listed method-of-use patent (U-124) expiration.
Jun 03, 2029
in 3 yr
Patent 8895070 expires
Listed method-of-use patent (U-124) expiration.
Jun 03, 2029
in 3 yr
Patent 9078870 expires
Listed drug product patent expiration.
Jun 03, 2029
in 3 yr
Patent 8288434 expires
Listed drug product patent expiration.
Aug 05, 2029
in 3 yr 2 mo

Active ingredient

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Strength

2.5%;EQ 1.2% BASE

Dosage form

GEL

Route

TOPICAL

TE code

Application

NDA 050819

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
10220049	Jun 03, 2029	in 3 yr	ProductU-916
10624918	Jun 03, 2029	in 3 yr	U-916
8663699	Jun 03, 2029	in 3 yr	U-124
8895070	Jun 03, 2029	in 3 yr	U-124
9078870	Jun 03, 2029	in 3 yr	Product
8288434	Aug 05, 2029	in 3 yr 2 mo	ProductU-124