FDA Orange Book · active-ingredient family
Adapalene
Adapalene is approved as 5 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIFFERIN · NDA 020380
5
Brand (NDA)
10
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, gel, lotion, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIFFERINRLD | GALDERMA LABS LP | NDA 020380 | — | Jul 08, 2016 | |
| DIFFERINRLD | GALDERMA LABS LP | NDA 022502 | — | Mar 17, 2010 | |
| DIFFERINRLD | GALDERMA LABS LP | NDA 021753 | AB | Jun 19, 2007 | |
| DIFFERINRLD | GALDERMA LABS LP | NDA 020748 | AB | May 26, 2000 | |
| DIFFERINRLD | GALDERMA LABS LP | NDA 020338 | — | May 31, 1996 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADAPALENE | SUN PHARMA CANADA | ANDA 215940 | — | Jan 14, 2022 | |
| ADAPALENE | ALEMBIC | ANDA 213508 | AB | Jun 18, 2020 | |
| ADAPALENE | WAYLIS THERAP | ANDA 203981 | AB | Sep 23, 2016 | |
| ADAPALENE | SUN PHARMA CANADA | ANDA 208322 | AB | Jun 23, 2016 | |
| ADAPALENE | WAYLIS THERAP | ANDA 204593 | AB | Jan 05, 2016 | |
| ADAPALENE | ACTAVIS MID ATLANTIC | ANDA 201000 | AB | Oct 27, 2014 | |
| ADAPALENE | ENCUBE ETHICALS | ANDA 200298 | AB | Jun 14, 2012 | |
| ADAPALENE | GLENMARK PHARMS | ANDA 091314 | — | Jul 01, 2010 | |
| ADAPALENE | FOUGERA PHARMS | ANDA 090824 | AB | Jun 30, 2010 | |
| ADAPALENE | P AND L | ANDA 090962 | — | Jun 02, 2010 |
Listed patents (3)
| 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 |
Adapalene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
