FDA Orange Book · active-ingredient family
Tretinoin
Tretinoin is approved as 14 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALTRENO · NDA 209353
14
Brand (NDA)
31
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, cream, gel, lotion, solution, swab
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALTRENORLD | DOW PHARM | NDA 209353 | — | Aug 23, 2018 | |
| ATRALINRLD | DOW PHARM | NDA 022070 | AB | Jul 26, 2007 | |
| RETIN-A MICRORLD×4 | BAUSCH | NDA 020475 | — | May 10, 2002 | |
| RENOVARLD | VALEANT PHARMS NORTH | NDA 021108 | — | Aug 31, 2000 | |
| RENOVARLD | VALEANT PHARMS NORTH | NDA 019963 | — | Dec 29, 1995 | |
| VESANOIDRLD | CHEPLAPHARM | NDA 020438 | — | Nov 22, 1995 | |
| RETIN-ARLD | BAUSCH | NDA 019049 | AB | Sep 16, 1988 | |
| RETIN-ARLD | VALEANT BERMUDA | NDA 017522 | AB1 | Approved Prior to Jan 1, 1982 | |
| RETIN-ARLD | VALEANT PHARMS NORTH | NDA 017340 | AB | Approved Prior to Jan 1, 1982 | |
| RETIN-ARLD | BAUSCH | NDA 017955 | AB | Approved Prior to Jan 1, 1982 | |
| RETIN-ARLD | VALEANT INTL | NDA 017579 | AB | Approved Prior to Jan 1, 1982 | |
| RETIN-ARLD×2 | VALEANT INTL | NDA 016921 | — | Approved Prior to Jan 1, 1982 | |
| AVITA | RISING | NDA 020400 | — | Jan 29, 1998 | |
| AVITA | MYLAN PHARMS INC | NDA 020404 | AB | Jan 14, 1997 |
Generic (ANDA) products (31)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRETINOIN | AMNEAL | ANDA 217497 | AB | May 14, 2026 | |
| TRETINOIN MICROSPHERE×2 | ENCUBE | ANDA 215609 | AB | Apr 15, 2026 | |
| TRETINOIN | ENCUBE | ANDA 217832 | AB1 | Mar 25, 2026 | |
| TRETINOIN | ENCUBE | ANDA 217833 | AB | Feb 10, 2026 | |
| TRETINOIN | ALEMBIC | ANDA 218399 | AB | Aug 14, 2025 | |
| TRETINOIN | ENCUBE | ANDA 217831 | AB | Jul 10, 2025 | |
| TRETINOIN | ENCUBE | ANDA 217588 | AB | Mar 03, 2025 | |
| TRETINOIN | ENCUBE | ANDA 217587 | AB | Mar 03, 2025 | |
| TRETINOIN | AUROBINDO PHARMA LTD | ANDA 218245 | AB | Feb 27, 2025 | |
| TRETINOIN | AUROBINDO PHARMA LTD | ANDA 218246 | AB | Jan 13, 2025 | |
| TRETINOIN | ALEMBIC | ANDA 217804 | AB | Apr 29, 2024 | |
| TRETINOIN | ZYDUS LIFESCIENCES | ANDA 218561 | AB | Apr 25, 2024 | |
| TRETINOIN | SUN PHARMA CANADA | ANDA 215713 | AB | Jan 05, 2023 | |
| TRETINOIN | SUN PHARMA CANADA | ANDA 211644 | AB1 | Jan 25, 2019 | |
| TRETINOIN | SUN PHARMA CANADA | ANDA 211645 | AB | Jan 22, 2019 | |
| TRETINOIN | GLENMARK PHARMS LTD | ANDA 208279 | AB | Dec 23, 2016 | |
| TRETINOIN | MYLAN | ANDA 207955 | AB | Aug 13, 2015 | |
| TRETINOIN | RISING | ANDA 202567 | — | Jul 17, 2013 | |
| TRETINOIN | RISING | ANDA 202026 | — | Jul 17, 2013 | |
| TRETINOIN | PH HEALTH | ANDA 201687 | AB | Oct 24, 2012 | |
| TRETINOIN | ALLERGAN | ANDA 202209 | — | Oct 11, 2012 | |
| TRETINOIN | ALLERGAN | ANDA 090098 | — | Mar 22, 2010 | |
| TRETINOIN | BARR LABS INC | ANDA 077684 | — | Jun 22, 2007 | |
| TRETINOIN | ZO SKIN HEALTH | ANDA 076498 | — | Sep 15, 2005 | |
| TRETINOIN | PADAGIS US | ANDA 075589 | AB | Jun 11, 2002 | |
| TRETINOIN | PADAGIS US | ANDA 075529 | AB | Feb 22, 2000 | |
| TRETINOIN | WOCKHARDT | ANDA 075260 | — | Jan 25, 1999 | |
| TRETINOIN | PADAGIS US | ANDA 075264 | AB | Dec 24, 1998 | |
| TRETINOIN | PADAGIS US | ANDA 075265 | AB1 | Dec 24, 1998 | |
| TRETINOIN | PADAGIS US | ANDA 075213 | AB | Dec 24, 1998 | |
| TRETINOIN | TEVA PHARMS | ANDA 074873 | — | Jun 19, 1998 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10653656 | Aug 22, 2038 | in 12 yr 4 mo | ProductU-2368 |
| 11324710 | Aug 22, 2038 | in 12 yr 4 mo | U-2368 |
Tretinoin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
