FDA Orange Book
Generic for Abilify
Abilify contains aripiprazole. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Abilify is aripiprazole. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 11 of the 12 Abilify products the Orange Book lists.
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Abilify products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intramuscular | 9.75MG/1.3ML (7.5MG/ML) | Discontinued | None | 0 | None |
| solution, oral | 1MG/ML | Discontinued | None | 9 | AA |
| tablet, orally disintegrating, oral | 10MG | Discontinued | None | 4 | AB |
| tablet, orally disintegrating, oral | 15MG | Discontinued | None | 4 | AB |
| tablet, orally disintegrating, oral | 20MG | Discontinued | None | 1 | None |
| tablet, orally disintegrating, oral | 30MG | Discontinued | None | 1 | None |
| tablet, oral | 10MG | Marketed (Rx) | AB | 14 | AB |
| tablet, oral | 15MG | Marketed (Rx) | AB | 13 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 13 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 14 | AB |
| tablet, oral | 30MG | Marketed (Rx) | AB | 13 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 14 | AB |
NDA 021866, 021713, 021729, 021436, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic aripiprazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 202102 | AB (A-rated, therapeutically equivalent) | April 28, 2015 | 10MG, 15MG |
| ALEMBIC PHARMACEUTICALS LTD | 202101 | AB (A-rated, therapeutically equivalent) | April 28, 2015 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| HETERO LABS LTD UNIT V | 205064 | AB (A-rated, therapeutically equivalent) | April 28, 2015 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| TORRENT PHARMACEUTICALS LTD | 201519 | AB (A-rated, therapeutically equivalent) | April 28, 2015 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| AMNEAL PHARMACEUTICALS | 203906 | AA (A-rated, therapeutically equivalent) | August 14, 2015 | 1MG/ML |
| LANNETT CO INC | 204171 | AA (A-rated, therapeutically equivalent) | August 14, 2015 | 1MG/ML |
| APOTEX INC | 204094 | AA (A-rated, therapeutically equivalent) | September 30, 2015 | 1MG/ML |
| AUROBINDO PHARMA LTD | 203908 | AB (A-rated, therapeutically equivalent) | October 8, 2015 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| AMNEAL PHARMACEUTICALS | 204838 | AB (A-rated, therapeutically equivalent) | June 17, 2016 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| AJANTA PHARMA LTD | 206174 | AB (A-rated, therapeutically equivalent) | September 12, 2016 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| SCIEGEN PHARMACEUTICALS INC | 206383 | AB (A-rated, therapeutically equivalent) | September 29, 2016 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 204111 | AB (A-rated, therapeutically equivalent) | October 7, 2016 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| ACCORD HEALTHCARE INC | 206251 | AB (A-rated, therapeutically equivalent) | December 7, 2016 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 202683 | AB (A-rated, therapeutically equivalent) | May 23, 2017 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 205363 | AB (A-rated, therapeutically equivalent) | December 4, 2017 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 202547 | AB (A-rated, therapeutically equivalent) | December 11, 2017 | 10MG, 15MG |
| SCIEGEN PHARMACEUTICALS INC | 207240 | AB (A-rated, therapeutically equivalent) | April 18, 2018 | 10MG, 15MG |
| SQUARE PHARMACEUTICALS LTD | 090165 | AB (A-rated, therapeutically equivalent) | August 28, 2018 | 10MG, 15MG, 20MG, 30MG |
| AUROBINDO PHARMA LTD | 210479 | AA (A-rated, therapeutically equivalent) | January 29, 2019 | 1MG/ML |
| ALKEM LABORATORIES LTD | 207105 | AB (A-rated, therapeutically equivalent) | February 21, 2019 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| VISTAPHARM LLC | 212870 | AA (A-rated, therapeutically equivalent) | December 26, 2019 | 1MG/ML |
| UNICHEM LABORATORIES LTD | 203025 | AB (A-rated, therapeutically equivalent) | December 1, 2021 | 10MG, 15MG, 20MG, 2MG, 30MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 215595 | AA (A-rated, therapeutically equivalent) | October 25, 2022 | 1MG/ML |
| RUBICON RESEARCH LTD | 216351 | AA (A-rated, therapeutically equivalent) | October 27, 2022 | 1MG/ML |
| SUNSHINE LAKE PHARMA CO LTD | 213037 | AB (A-rated, therapeutically equivalent) | October 2, 2023 | 10MG, 2MG, 5MG |
| HETERO LABS LTD UNIT III | 216150 | AA (A-rated, therapeutically equivalent) | November 1, 2023 | 1MG/ML |
| QUAGEN PHARMACEUTICALS LLC | 215582 | AA (A-rated, therapeutically equivalent) | October 22, 2025 | 1MG/ML |
Abilify patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9125939 | July 28, 2026 | Method of use | U-1749 | 021729 |
| 8759350 | March 2, 2027 | Method of use | U-1529 | 021713 |
Abilify NDC codes
Questions
Is there a generic for Abilify?
Yes. The generic name for Abilify is aripiprazole. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 11 of the 12 Abilify products the Orange Book lists.
What is the generic name for Abilify?
The active ingredient in Abilify is aripiprazole, per the FDA Orange Book.
When does the Abilify patent expire?
The last patent listed for Abilify in the Orange Book expires March 2, 2027. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
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