Orange Book product · Brand (NDA)

DIFFERIN

ADAPALENE

Brand (NDA)NDA 022502DISCN GALDERMA LABS LP

Mar 17, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 17, 2010
16 yr 6 mo ago
Today
Patent 8435502 expires
Listed drug product patent expiration.
Sep 15, 2026
in 3 mo
Patent 8709392 expires
Listed drug product patent expiration.
Sep 15, 2026
in 3 mo
Patent 7998467 expires
Listed drug product patent expiration.
May 31, 2028
in 2 yr

Active ingredient

ADAPALENE

Strength

0.1%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

NDA 022502

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
8435502	Sep 15, 2026	in 3 mo	ProductU-1078
8709392	Sep 15, 2026	in 3 mo	ProductU-1078
7998467	May 31, 2028	in 2 yr	ProductU-1078