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Generic Abilify Availability

Abilify is a brand name of aripiprazole, approved by the FDA in the following formulation(s):

ABILIFY (aripiprazole - injectable;intramuscular)

  • Manufacturer: OTSUKA
    Approval date: September 20, 2006
    Strength(s): 9.75MG/1.3ML (7.5MG/ML)

ABILIFY (aripiprazole - solution;oral)

  • Manufacturer: OTSUKA
    Approval date: December 10, 2004
    Strength(s): 1MG/ML

ABILIFY (aripiprazole - tablet, orally disintegrating;oral)

  • Manufacturer: OTSUKA
    Approval date: June 7, 2006
    Strength(s): 10MG, 15MG, 20MG, 30MG

ABILIFY (aripiprazole - tablet;oral)

  • Manufacturer: OTSUKA
    Approval date: November 15, 2002
    Strength(s): 2MG [AB], 5MG [RLD] [AB], 10MG [RLD] [AB], 15MG [AB], 20MG [AB], 30MG [AB]

Has a generic version of Abilify been approved?

A generic version of Abilify has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Abilify and have been approved by the FDA:

aripiprazole tablet;oral

  • Manufacturer: AJANTA PHARMA LTD
    Approval date: September 12, 2016
    Strength(s): 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB], 2MG [AB]
  • Manufacturer: ALEMBIC PHARMS LTD
    Approval date: April 28, 2015
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: AMNEAL PHARMS
    Approval date: June 17, 2016
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: July 24, 2015
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: October 8, 2015
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: April 28, 2015
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: October 7, 2016
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: SCIEGEN PHARMS INC
    Approval date: September 29, 2016
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: April 28, 2015
    Strength(s): 2MG [AB], 5MG [AB], 10MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: April 28, 2015
    Strength(s): 2MG [AB], 10MG [AB], 5MG [AB], 15MG [AB], 20MG [AB], 30MG [AB]

Note: No generic formulation of the following products are available.

  • aripiprazole - injectable;intramuscular
  • aripiprazole - solution;oral
  • aripiprazole - tablet, orally disintegrating;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Abilify. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Aripiprazole oral solution
    Patent 6,977,257
    Issued: December 20, 2005
    Inventor(s): Parab; Prakash V. & Chou; Joyc Tianw i
    Assignee(s): Bristol-Myers Squibb Company
    The present invention provides for a pharmaceutical solution suitable for oral administration comprising aripiprazole, a pharmaceutically suitable solvent system, one or more taste-enhancing/masking agents and one or more agents selected from the group consisting of lactic acid, acetic acid, tartaric acid and citric acid, wherein said solution has a pH from 2.5 to 4.5.
    Patent expiration dates:
    • April 24, 2022
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      Drug product
    • October 24, 2022
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      Pediatric exclusivity
  • 5-HT1a receptor subtype agonist
    Patent 7,053,092
    Issued: May 30, 2006
    Inventor(s): Jordon; Shaun & Kikuchi; Tetsuro & Tottori; Katsura & Hirose; Tsuyoshi & Uwahodo; Yasufumi
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention relates to a method of treating a patient suffering from a disorder of the central nervous system associated with 5-HT1A receptor subtype, comprising as an active ingredient a carbostyril derivative or a salt thereof represented by the formula (1): wherein the carbon-carbon bond between 3- and 4-positions in the carbostyril skeleton is a single or a double bond.
    Patent expiration dates:
    • January 28, 2022
      ✓ 
      Patent use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
  • Aripiprazole complex formulation and method
    Patent 7,115,587
    Issued: October 3, 2006
    Inventor(s): Nerurkar; Manoj & Naringrekar; Vijay
    Assignee(s): Bristol-Myers Squibb Company
    An aripiprazole formulation is provided which includes the antipsychotic agent aripiprazole in the form of an inclusion complex in a β-cyclodextrin, preferably, sulfobutyl ether β-cyclodextrin (SBECD), which in the form of an injectable produces reversible generally minimal to mild irritation at the intramuscular injection site. A method for minimizing or reducing irritation caused by aripiprazole at an intramuscular injection site and a method for treating schizophrenia employing the above formulation are also provided.
    Patent expiration dates:
    • July 21, 2024
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      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug product
    • January 21, 2025
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      Pediatric exclusivity
  • Aripiprazole complex formulation and method
    Patent 7,550,445
    Issued: June 23, 2009
    Inventor(s): Nerurkar; Manoj & Naringrekar; Vijay
    Assignee(s): Bristol-Myers Squibb Company
    An aripiprazole formulation is provided which includes the antipsychotic agent aripiprazole in the form of an inclusion complex in a β-cyclodextrin, preferably, sulfobutyl ether β-cyclodextrin (SBECD), which in the form of an injectable produces reversible generally minimal to mild irritation at the intramuscular injection site. A method for minimizing or reducing irritation caused by aripiprazole at an intramuscular injection site and a method for treating schizophrenia employing the above formulation are also provided.
    Patent expiration dates:
    • July 21, 2024
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      Drug product
    • January 21, 2025
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      Pediatric exclusivity
  • Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
    Patent 8,017,615
    Issued: September 13, 2011
    Inventor(s): Bando; Takuji & Aoki; Satoshi & Kawasaki; Junichi & Ishigami; Makoto & Taniguchi; Youichi & Yabuuchi; Tsuyoshi & Fujimoto; Kiyoshi & Nishioka; Yoshihiro & Kobayashi; Noriyuki & Fujimura; Tsutomu & Takahashi; Masanori & Abe; Kaoru & Nakagawa; Tomonori & Shinhama; Koichi & Utsumi; Nao
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention provides low hygroscopic forms of aripiprazole and processes for the preparation thereof which will not convert to a hydrate or lose their original solubility even when a medicinal preparation containing the anhydrous aripiprazole crystals is stored for an extended period.
    Patent expiration dates:
    • June 16, 2024
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      Drug product
    • December 16, 2024
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      Pediatric exclusivity
  • Flashmelt oral dosage formulation
    Patent 8,518,421
    Issued: August 27, 2013
    Assignee(s): Bristol-Myers Squibb Company
    There is provided granules for the production of flash-melt pharmaceutical oral dosage forms. In addition to one or more medicaments, the granules are composed of an excipient combination consisting of a superdisintegrant, a dispersing agent, a distributing agent, and a binder and may also include other conventional ingredients such as sweetening and flavoring agents. The subject granules are advantageous in that they are stable and can be prepared without the aid of solvents and without the need for special environments or handling. Dosage forms, especially tablets, prepared therefrom on conventional equipment disintegrate in the mouth in under about twenty five seconds.
    Patent expiration dates:
    • January 24, 2021
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      Drug product
    • July 24, 2021
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      Pediatric exclusivity
  • Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
    Patent 8,580,796
    Issued: November 12, 2013
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention provides low hygroscopic forms of aripiprazole and processes for the preparation thereof which will not convert to a hydrate or lose their original solubility even when a medicinal preparation containing the anhydrous Aripiprazole crystals is stored for an extended period.
    Patent expiration dates:
    • September 25, 2022
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      Drug substance
    • March 25, 2023
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      Pediatric exclusivity
  • Method of treating autism
    Patent 8,642,600
    Issued: February 4, 2014
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention relates to a method of treating a patient suffering from a disorder of the central nervous system associated with 5-HT1A receptor subtype, comprising as an active ingredient a carbostyril derivative or a salt thereof represented by the formula (1): wherein the carbon-carbon bond between 3- and 4-positions in the carbostyril skeleton is a single or a double bond.
    Patent expiration dates:
    • January 28, 2022
      ✓ 
      Patent use: TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    • July 28, 2022
      ✓ 
      Pediatric exclusivity
  • Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
    Patent 8,642,760
    Issued: February 4, 2014
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention provides low hygroscopic forms of aripiprazole and processes for the preparation thereof which will not convert to a hydrate or lose their original solubility even when a medicinal preparation containing the anhydrous Aripiprazole crystals is stored for an extended period.
    Patent expiration dates:
    • September 25, 2022
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      Drug substance
    • March 25, 2023
      ✓ 
      Pediatric exclusivity
  • Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
    Patent 8,759,350
    Issued: June 24, 2014
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The pharmaceutical composition of the present invention comprises (1) a carbostyril derivative and (2) a serotonin reuptake inhibitor in a pharmaceutically acceptable carrier. The carbostyril derivative may be aripiprazole or a metabolite thereof, which is a dopamine-serotonin system stabilizer. The serotonin reuptake inhibitor may be fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline or escitalopram. The pharmaceutical composition of the present invention is useful for treating patients with mood disorders, particularly depression or major depressive disorder.
    Patent expiration dates:
    • March 2, 2027
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      Patent use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
  • Method of treating cognitive impairments and schizophrenias
    Patent 9,089,567
    Issued: July 28, 2015
    Assignee(s): Otsuka Pharmaceutical Co., LTD.
    The present invention relates to a method of treating a patient suffering from a disorder of the central nervous system associated with 5-HT1A receptor subtype, comprising as an active ingredient a carbostyril derivative or a salt thereof represented by the formula (1) wherein the carbon-carbon bond between 3- and 4-positions in the carbostyril skeleton is a single or a double bond.
    Patent expiration dates:
    • January 28, 2022
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      Patent use: TREATMENT OF SCHIZOPHRENIA
  • Carbostyril derivatives and mood stabilizers for treating mood disorders
    Patent 9,125,939
    Issued: September 8, 2015
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The pharmaceutical composition of the present invention comprises a carbostyril derivative which is a dopamine-sero-tonin system stabilizer and a mood stabilizer in a pharmaceutically acceptable carrier. The carbostyril derivative may be aripiprazole or a metabolite thereof. The mood stabilizer may include but is not limited to lithium, valproic acid, divalproex sodium, carbamaza-pine, oxcarbamazapine, zonisamide, lamotragine, topiramate, gabapentin, levetiracetam or clonazepam. These compositions are used to treat patients with mood disorders, particularly bipolar disorder with or without psychotic features, mania or mixed episodes. Methods are provided for separate administration of a carbostyril derivative and a mood stabilizer to a patient with a mood disorder.
    Patent expiration dates:
    • July 28, 2026
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      Patent use: ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
  • Flashmelt oral dosage formulation
    Patent 9,358,207
    Issued: June 7, 2016
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    There is provided granules for the production of flash-melt pharmaceutical oral dosage forms. In addition to one or more medicaments, the granules are composed of an excipient combination consisting of a superdisintegrant, a dispersing agent, a distributing agent, and a binder and may also include other conventional ingredients such as sweetening and flavoring agents. The subject granules are advantageous in that they are stable and can be prepared without the aid of solvents and without the need for special environments or handling. Dosage forms, especially tablets, prepared therefrom on conventional equipment disintegrate in the mouth in under about twenty five seconds.
    Patent expiration dates:
    • April 12, 2020
      ✓ 
      Drug product
  • Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
    Patent 9,359,302
    Issued: June 7, 2016
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention provides low hygroscopic forms of aripiprazole and processes for the preparation thereof which will not convert to a hydrate or lose their original solubility even when a medicinal preparation containing the anhydrous aripiprazole crystals is stored for an extended period.
    Patent expiration dates:
    • September 25, 2022
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
    Patent 9,387,182
    Issued: July 12, 2016
    Assignee(s): OTSUKA PHARMACEUTICAL CO., LTD.
    The pharmaceutical composition of the present invention comprises (1) a carbostyril derivative and (2) a serotonin reuptake inhibitor in a pharmaceutically acceptable carrier. The carbostyril derivative may be aripiprazole or a metabolite thereof, which is a dopamine-serotonin system stabilizer. The serotonin reuptake inhibitor may be fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline or escitalopram. The pharmaceutical composition of the present invention is useful for treating patients with mood disorders, particularly depression or major depressive disorder.
    Patent expiration dates:
    • December 25, 2023
      ✓ 
      Patent use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • June 9, 2017 - LABELING REVISIONS RESULTING FROM A MAINTENANCE TRIAL IN PEDIATRIC PATIENTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    • December 12, 2017 - TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S DISORDER (6-18 YEARS)
    • December 12, 2021 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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