FDA Orange Book · active-ingredient family
Aripiprazole
Aripiprazole: 9 brands, 37 generics; first approved Nov 15, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 37 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
9
Generics (ANDA)
37
Listed patents
40
Next patent expiry
Apr 28, 2026
4 mo ago
Brand (NDA) products
Originator applications
- MEZOFYRLDCMG PHARM CO LTDNDA 21144820253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG FILM ORAL Discontinued — 10MG FILM ORAL Discontinued — 15MG FILM ORAL Discontinued — - OPIPZARLDXIAMEN LP PHARM CONDA 21665520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG FILM ORAL Rx — 5MG FILM ORAL Rx — 10MG FILM ORAL Rx — - OTSUKANDA 21700620232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 720MG/2.4ML (300MG/ML) SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Rx — 960MG/3.2ML (300MG/ML) SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Rx — - OTSUKANDA 20720220176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - OTSUKA PHARM CO LTDNDA 20297120134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/VIAL FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Rx — 400MG/VIAL FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Rx — 300MG FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Rx — 400MG FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Rx — - ABILIFYRLDOTSUKANDA 02172920064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 15MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 20MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 30MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - ABILIFYRLDOTSUKANDA 0217132004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Discontinued — - ABILIFYRLDOTSUKANDA 02143620026 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - OTSUKANDA 0218662006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 9.75MG/1.3ML (7.5MG/ML) INJECTABLE INTRAMUSCULAR Discontinued —
Generic (ANDA) products (37)
Abbreviated applications
- ARIPIPRAZOLEAUROBINDO PHARMAANDA 21620820262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - ARIPIPRAZOLEQUAGENANDA 2155822025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLEMYLANANDA 21660820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/VIAL FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Discontinued — 400MG/VIAL FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR Discontinued — - ARIPIPRAZOLELUPINANDA 20558920246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - ARIPIPRAZOLEHETERO LABS LTD IIIANDA 2161502023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLESUNSHINEANDA 21303720233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - ARIPIPRAZOLERUBICON RESEARCHANDA 2163512022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLECHARTWELL RXANDA 2155952022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLEUNICHEMANDA 20302520216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEVISTAPHARM LLCANDA 2128702019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLEALKEM LABS LTDANDA 20710520196 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEAUROBINDO PHARMA LTDANDA 2104792019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLEZYDUS PHARMSANDA 09047220196 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - ARIPIPRAZOLERISINGANDA 20624020186 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - ARIPIPRAZOLESQUARE PHARMSANDA 09016520184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 20MG TABLET, ORALLY DISINTEGRATING ORAL Rx — 30MG TABLET, ORALLY DISINTEGRATING ORAL Rx — - ARIPIPRAZOLESCIEGEN PHARMSANDA 20724020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - ARIPIPRAZOLEORBION PHARMSANDA 20254720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - ARIPIPRAZOLEPRINSTON INCANDA 20536320176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEORBION PHARMSANDA 20268320176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEAIPING PHARM INCANDA 09127920176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - ARIPIPRAZOLEACCORD HLTHCAREANDA 20625120166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEMACLEODS PHARMS LTDANDA 20411120166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLESCIEGEN PHARMSANDA 20638320166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEAJANTA PHARMA LTDANDA 20617420166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEAMNEAL PHARMSANDA 20483820166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEAUROBINDO PHARMAANDA 20390820156 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEAPOTEXANDA 2040942015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLERSAMNEAL PHARMSANDA 2039062015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLELANNETT CO INCANDA 2041712015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SOLUTION ORAL Rx AA - ARIPIPRAZOLEAPOTEXANDA 07858320156 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - ARIPIPRAZOLERSALEMBICANDA 20210220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 15MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - ARIPIPRAZOLEALEMBICANDA 20210120156 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLEHETERO LABS LTD VANDA 20506420156 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB - ARIPIPRAZOLETEVA PHARMS USAANDA 07860720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - ARIPIPRAZOLETEVA PHARMS USAANDA 0786082015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - ARIPIPRAZOLETEVA PHARMS USAANDA 07870820153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — - ARIPIPRAZOLETORRENTANDA 20151920156 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11476952 | 4 mo ago | Product | |
| 9125939 | 15 d ago | U-1749 | |
| 7978064 | in 1 mo | Product | |
| 8759350 | in 7 mo | U-1529 | |
| 9444503 | in 1 yr 3 mo | ProductU-2169 | |
| 9119554 | in 2 yr 5 mo | Product | |
| 9060708 | in 2 yr 7 mo | Product | |
| 9258035 | in 2 yr 7 mo | Product | |
| 8674825 | in 2 yr 8 mo | ProductU-2170 | |
| 8956288 | in 2 yr 11 mo | ProductU-2167 | |
| 10441194 | in 3 yr | Product | |
| 8945005 | in 3 yr 1 mo | ProductU-2167 | |
| 9433371 | in 3 yr 2 mo | Product | |
| 8718193 | in 3 yr 4 mo | Product | |
| 9149577 | in 3 yr 5 mo | Product | |
| 8847766 | in 3 yr 8 mo | ProductU-2167 | |
| 8545402 | in 3 yr 9 mo | Product | |
| 8114021 | in 3 yr 11 mo | Product | |
| 11464423 | in 4 yr 2 mo | Product | |
| 9941931 | in 4 yr 4 mo | Product | |
| 8961412 | in 4 yr 4 mo | Product | |
| 8258962 | in 4 yr 4 mo | Product | |
| 8547248 | in 4 yr 5 mo | ProductU-2167 | |
| 11229378 | in 5 yr | Product | |
| 9320455 | in 5 yr 5 mo | Product | |
| 10517507 | in 5 yr 11 mo | Product | |
| 12016927 | in 6 yr 10 mo | ProductU-3245 | |
| 11638757 | in 6 yr 10 mo | ProductU-3245 | |
| 11097007 | in 6 yr 10 mo | ProductU-3245 | |
| 10517951 | in 6 yr 10 mo | ProductU-3245 | |
| 9694008 | in 7 yr 1 mo | Product | |
| 11344547 | in 7 yr 3 mo | U-1632 | |
| 11400087 | in 7 yr 3 mo | U-3245 | |
| 10980803 | in 7 yr 3 mo | U-543 | |
| 11154553 | in 7 yr 3 mo | U-1632 | |
| 9268909 | in 7 yr 3 mo | ProductU-2168 | |
| 10525057 | in 7 yr 8 mo | U-543 | |
| 11648347 | in 7 yr 9 mo | Product | |
| 11331315 | in 14 yr 5 mo | Product | |
| 11701352 | in 15 yr 7 mo | Product |
Approval history
FDA approval span
First approval
24 yr 1 mo ago
Most recent approval
6 mo ago
Approvals span 2002–2026 across 46 FDA applications.
Brand (NDA) 920%
Generic (ANDA) 3780%
Aripiprazole: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
