FDA Orange Book · active-ingredient family
Aripiprazole
Aripiprazole is approved as 9 brand and 37 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MEZOFY · NDA 211448
9
Brand (NDA)
37
Generics (ANDA)
40
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, for suspension, extended release, injectable, solution, suspension, extended release, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEZOFYRLD×3 | CMG PHARM CO LTD | NDA 211448 | — | Apr 15, 2025 | |
| OPIPZARLD×3 | XIAMEN LP PHARM CO | NDA 216655 | — | Jul 22, 2024 | |
| ABILIFY ASIMTUFIIRLD×2 | OTSUKA | NDA 217006 | — | Apr 27, 2023 | |
| ABILIFY MYCITE KITRLD×6 | OTSUKA | NDA 207202 | — | Nov 13, 2017 | |
| ABILIFY MAINTENA KITRLD×4 | OTSUKA PHARM CO LTD | NDA 202971 | — | Feb 28, 2013 | |
| ABILIFYRLD×4 | OTSUKA | NDA 021729 | — | Jun 07, 2006 | |
| ABILIFYRLD | OTSUKA | NDA 021713 | — | Dec 10, 2004 | |
| ABILIFYRLD×6 | OTSUKA | NDA 021436 | AB | Nov 15, 2002 | |
| ABILIFY | OTSUKA | NDA 021866 | — | Sep 20, 2006 |
Generic (ANDA) products (37)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARIPIPRAZOLE×2 | AUROBINDO PHARMA | ANDA 216208 | AB | Feb 18, 2026 | |
| ARIPIPRAZOLE | QUAGEN | ANDA 215582 | AA | Oct 22, 2025 | |
| ARIPIPRAZOLE×2 | MYLAN | ANDA 216608 | — | Dec 03, 2024 | |
| ARIPIPRAZOLE×6 | LUPIN | ANDA 205589 | — | Mar 18, 2024 | |
| ARIPIPRAZOLE | HETERO LABS LTD III | ANDA 216150 | AA | Nov 01, 2023 | |
| ARIPIPRAZOLE×3 | SUNSHINE | ANDA 213037 | AB | Oct 02, 2023 | |
| ARIPIPRAZOLE | RUBICON RESEARCH | ANDA 216351 | AA | Oct 27, 2022 | |
| ARIPIPRAZOLE | CHARTWELL RX | ANDA 215595 | AA | Oct 25, 2022 | |
| ARIPIPRAZOLE×6 | UNICHEM | ANDA 203025 | AB | Dec 01, 2021 | |
| ARIPIPRAZOLE | VISTAPHARM LLC | ANDA 212870 | AA | Dec 26, 2019 | |
| ARIPIPRAZOLE×6 | ALKEM LABS LTD | ANDA 207105 | AB | Feb 21, 2019 | |
| ARIPIPRAZOLE | AUROBINDO PHARMA LTD | ANDA 210479 | AA | Jan 29, 2019 | |
| ARIPIPRAZOLE×6 | ZYDUS PHARMS | ANDA 090472 | — | Jan 07, 2019 | |
| ARIPIPRAZOLE×6 | RISING | ANDA 206240 | — | Sep 19, 2018 | |
| ARIPIPRAZOLE×4 | SQUARE PHARMS | ANDA 090165 | AB | Aug 28, 2018 | |
| ARIPIPRAZOLE×2 | SCIEGEN PHARMS | ANDA 207240 | AB | Apr 18, 2018 | |
| ARIPIPRAZOLE×2 | ORBION PHARMS | ANDA 202547 | AB | Dec 11, 2017 | |
| ARIPIPRAZOLE×6 | PRINSTON INC | ANDA 205363 | AB | Dec 04, 2017 | |
| ARIPIPRAZOLE×6 | ORBION PHARMS | ANDA 202683 | AB | May 23, 2017 | |
| ARIPIPRAZOLE×6 | AIPING PHARM INC | ANDA 091279 | — | Jan 09, 2017 | |
| ARIPIPRAZOLE×6 | ACCORD HLTHCARE | ANDA 206251 | AB | Dec 07, 2016 | |
| ARIPIPRAZOLE×6 | MACLEODS PHARMS LTD | ANDA 204111 | AB | Oct 07, 2016 | |
| ARIPIPRAZOLE×6 | SCIEGEN PHARMS | ANDA 206383 | AB | Sep 29, 2016 | |
| ARIPIPRAZOLE×6 | AJANTA PHARMA LTD | ANDA 206174 | AB | Sep 12, 2016 | |
| ARIPIPRAZOLE×6 | AMNEAL PHARMS | ANDA 204838 | AB | Jun 17, 2016 | |
| ARIPIPRAZOLE×6 | AUROBINDO PHARMA | ANDA 203908 | AB | Oct 08, 2015 | |
| ARIPIPRAZOLE | APOTEX | ANDA 204094 | AA | Sep 30, 2015 | |
| ARIPIPRAZOLE | AMNEAL PHARMS | ANDA 203906 | AA | Aug 14, 2015 | |
| ARIPIPRAZOLE | LANNETT CO INC | ANDA 204171 | AA | Aug 14, 2015 | |
| ARIPIPRAZOLE×6 | APOTEX | ANDA 078583 | — | Jul 24, 2015 | |
| ARIPIPRAZOLE×2 | ALEMBIC | ANDA 202102 | AB | Apr 28, 2015 | |
| ARIPIPRAZOLE×6 | ALEMBIC | ANDA 202101 | AB | Apr 28, 2015 | |
| ARIPIPRAZOLE×6 | HETERO LABS LTD V | ANDA 205064 | AB | Apr 28, 2015 | |
| ARIPIPRAZOLE×2 | TEVA PHARMS USA | ANDA 078607 | — | Apr 28, 2015 | |
| ARIPIPRAZOLE | TEVA PHARMS USA | ANDA 078608 | — | Apr 28, 2015 | |
| ARIPIPRAZOLE×3 | TEVA PHARMS USA | ANDA 078708 | — | Apr 28, 2015 | |
| ARIPIPRAZOLE×6 | TORRENT | ANDA 201519 | AB | Apr 28, 2015 |
Listed patents (40)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11476952 | Apr 28, 2026 | 2 mo ago | Product |
| 9125939 | Jul 28, 2026 | in 1 mo | U-1749 |
| 7978064 | Sep 14, 2026 | in 3 mo | Product |
| 8759350 | Mar 02, 2027 | in 9 mo | U-1529 |
| 9444503 | Nov 19, 2027 | in 1 yr 5 mo | ProductU-2169 |
| 9119554 | Dec 16, 2028 | in 2 yr 6 mo | Product |
| 9060708 | Mar 05, 2029 | in 2 yr 9 mo | Product |
| 9258035 | Mar 05, 2029 | in 2 yr 9 mo | Product |
| 8674825 | Apr 09, 2029 | in 2 yr 10 mo | ProductU-2170 |
| 8956288 | Jul 06, 2029 | in 3 yr 1 mo | ProductU-2167 |
| 10441194 | Jul 26, 2029 | in 3 yr 2 mo | Product |
| 8945005 | Aug 19, 2029 | in 3 yr 3 mo | ProductU-2167 |
| 9433371 | Sep 15, 2029 | in 3 yr 3 mo | Product |
| 8718193 | Dec 05, 2029 | in 3 yr 6 mo | Product |
| 9149577 | Dec 15, 2029 | in 3 yr 7 mo | Product |
| 8847766 | Mar 29, 2030 | in 3 yr 10 mo | ProductU-2167 |
| 8545402 | Apr 27, 2030 | in 3 yr 11 mo | Product |
| 8114021 | Jun 21, 2030 | in 4 yr 1 mo | Product |
| 11464423 | Sep 15, 2030 | in 4 yr 4 mo | Product |
| 9941931 | Nov 04, 2030 | in 4 yr 5 mo | Product |
| 8961412 | Nov 17, 2030 | in 4 yr 6 mo | Product |
| 8258962 | Nov 25, 2030 | in 4 yr 6 mo | Product |
| 8547248 | Dec 18, 2030 | in 4 yr 7 mo | ProductU-2167 |
| 11229378 | Jul 11, 2031 | in 5 yr 2 mo | Product |
| 9320455 | Dec 15, 2031 | in 5 yr 7 mo | Product |
| 10517507 | Jun 13, 2032 | in 6 yr 1 mo | Product |
| 12016927 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 11638757 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 11097007 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 10517951 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 9694008 | Aug 07, 2033 | in 7 yr 3 mo | Product |
| 11344547 | Sep 24, 2033 | in 7 yr 4 mo | U-1632 |
| 11400087 | Sep 24, 2033 | in 7 yr 4 mo | U-3245 |
| 10980803 | Sep 24, 2033 | in 7 yr 4 mo | U-543 |
| 11154553 | Sep 24, 2033 | in 7 yr 4 mo | U-1632 |
| 9268909 | Oct 15, 2033 | in 7 yr 5 mo | ProductU-2168 |
| 10525057 | Mar 08, 2034 | in 7 yr 10 mo | U-543 |
| 11648347 | Apr 06, 2034 | in 7 yr 11 mo | Product |
| 11331315 | Nov 03, 2040 | in 14 yr 7 mo | Product |
| 11701352 | Dec 15, 2041 | in 15 yr 9 mo | Product |
Aripiprazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
