Orange Book product · Brand (NDA)

EPIDUO

ADAPALENE; BENZOYL PEROXIDE

Brand (NDA)NDA 022320TE ABRX GALDERMA LABS LP

Dec 08, 2008

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 08, 2008
17 yr 9 mo ago
Today
Patent 8071644 expires
Listed drug product patent expiration.
Jul 18, 2027
in 1 yr 1 mo
Patent 8080537 expires
Listed method-of-use patent (U-1078) expiration.
Jul 18, 2027
in 1 yr 1 mo
Patent 8129362 expires
Listed method-of-use patent (U-1078) expiration.
Jul 18, 2027
in 1 yr 1 mo

Active ingredient

ADAPALENE; BENZOYL PEROXIDE

Strength

0.1%;2.5%

Dosage form

GEL

Route

TOPICAL

TE code

Application

NDA 022320

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
8071644	Jul 18, 2027	in 1 yr 1 mo	ProductU-1078
8080537	Jul 18, 2027	in 1 yr 1 mo	U-1078
8129362	Jul 18, 2027	in 1 yr 1 mo	U-1078