Aripiprazole Patent Expiration

Aripiprazole is used for acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder (MDD), and treatment of schizophrenia. It was first introduced by Otsuka Pharmaceutical Co Ltd in its drug Abilify on Nov 15, 2002. Other drugs containing Aripiprazole are Abilify Asimtufii, Mezofy, Abilify Maintena Kit, Opipza, Abilify Mycite Kit. 32 different companies have introduced drugs containing Aripiprazole.


Aripiprazole Patents

Given below is the list of patents protecting Aripiprazole, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Opipza US11701352 Process for preparing aripiprazole oral soluble film Dec 15, 2041 Xiamen Lp Pharm Co
Opipza US11331315 Aripiprazole oral soluble film Nov 03, 2040 Xiamen Lp Pharm Co
Abilify Mycite Kit US10097388 Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping Sep 19, 2034 Otsuka
Abilify Mycite Kit US9270503 Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping Sep 19, 2034 Otsuka
Abilify Mycite Kit US9787511 Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping Sep 19, 2034 Otsuka
Abilify Maintena Kit US11648347 Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient Apr 06, 2034 Otsuka Pharm Co Ltd
Abilify Maintena Kit US10525057 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Mar 08, 2034 Otsuka Pharm Co Ltd
Abilify Mycite Kit US9268909 Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device Oct 15, 2033 Otsuka
Abilify Mycite Kit US9577864 Method and apparatus for use with received electromagnetic signal at a frequency not known exactly in advance Oct 03, 2033 Otsuka
Abilify Maintena Kit US10980803 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Sep 24, 2033 Otsuka Pharm Co Ltd
Abilify Maintena Kit US11154553 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Sep 24, 2033 Otsuka Pharm Co Ltd
Abilify Maintena Kit US11344547 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Sep 24, 2033 Otsuka Pharm Co Ltd
Abilify Maintena Kit US11400087 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Sep 24, 2033 Otsuka Pharm Co Ltd
Mezofy US9694008 Fast-dissolving oral film preparation comprising aripiprazole Aug 07, 2033 Cmg Pharm Co Ltd
Abilify Asimtufii US10517951 Injectable preparation Apr 23, 2033 Otsuka
Abilify Asimtufii US11097007 Injectable preparation Apr 23, 2033 Otsuka
Abilify Asimtufii US11638757 Injectable preparation Apr 23, 2033 Otsuka
Abilify Asimtufii US12016927 Injectable preparation Apr 23, 2033 Otsuka
Abilify Mycite Kit US10517507 Communication system with enhanced partial power source and method of manufacturing same Jun 13, 2032 Otsuka
Abilify Mycite Kit US9320455 Highly reliable ingestible event markers and methods for using the same Dec 15, 2031 Otsuka
Abilify Mycite Kit US11229378 Communication system with enhanced partial power source and method of manufacturing same Jul 11, 2031 Otsuka
Abilify Mycite Kit US8547248 Implantable zero-wire communications system Dec 18, 2030 Otsuka
Abilify Mycite Kit US8258962 Multi-mode communication ingestible event markers and systems, and methods of using the same Nov 25, 2030 Otsuka
Abilify Mycite Kit US8961412 In-body device with virtual dipole signal amplification Nov 17, 2030 Otsuka
Abilify Mycite Kit US9941931 System for supply chain management Nov 04, 2030 Otsuka
Abilify Mycite Kit US11464423 In-body power source having high surface area electrode Sep 15, 2030 Otsuka
Abilify Mycite Kit US8114021 Body-associated receiver and method Jun 21, 2030 Otsuka
Abilify Mycite Kit US8545402 Highly reliable ingestible event markers and methods for using the same Apr 27, 2030 Otsuka
Abilify Mycite Kit US8847766 Pharma-informatics system Mar 29, 2030 Otsuka
Abilify Mycite Kit US9149577 Body-associated receiver and method Dec 15, 2029 Otsuka
Abilify Mycite Kit US8718193 Active signal processing personal health signal receivers Dec 05, 2029 Otsuka
Abilify Mycite Kit US9433371 In-body device with virtual dipole signal amplification Sep 15, 2029 Otsuka
Abilify Mycite Kit US8945005 Controlled activation ingestible identifier Aug 19, 2029 Otsuka
Abilify Mycite Kit US10441194 Ingestible event marker systems Jul 26, 2029 Otsuka
Abilify Mycite Kit US8956288 In-body power source having high surface area electrode Jul 06, 2029 Otsuka
Abilify Mycite Kit US8674825 Pharma-informatics system Apr 09, 2029 Otsuka
Abilify Mycite Kit US9060708 Multi-mode communication ingestible event markers and systems, and methods of using the same Mar 05, 2029 Otsuka
Abilify Mycite Kit US9258035 Multi-mode communication ingestible event markers and systems, and methods of using the same Mar 05, 2029 Otsuka
Abilify Mycite Kit US9119554 Pharma-informatics system Dec 16, 2028 Otsuka
Abilify Mycite Kit US9444503 Active signal processing personal health signal receivers Nov 19, 2027 Otsuka
Abilify US8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Mar 02, 2027 Otsuka
Abilify US8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Mar 02, 2027 Otsuka
Abilify Mycite Kit US8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Mar 02, 2027 Otsuka
Abilify Mycite Kit US7978064 Communication system with partial power source Sep 14, 2026 Otsuka
Abilify US9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Jul 28, 2026 Otsuka
Abilify Mycite Kit US9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Jul 28, 2026 Otsuka
Abilify Mycite Kit US11476952 Pharma-informatics system Apr 28, 2026 Otsuka
Abilify Asimtufii US8399469 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Jun 29, 2025

(Expired)

Otsuka
Abilify Maintena Kit US8399469 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Jun 29, 2025

(Expired)

Otsuka Pharm Co Ltd
Abilify Asimtufii US8338427 Methods for administering aripiprazole Mar 15, 2025

(Expired)

Otsuka
Abilify Maintena Kit US8338427 Methods for administering aripiprazole Mar 15, 2025

(Expired)

Otsuka Pharm Co Ltd
Abilify US7115587

(Pediatric)

Aripiprazole complex formulation and method Jan 21, 2025

(Expired)

Otsuka
Abilify US7550445

(Pediatric)

Aripiprazole complex formulation and method Jan 21, 2025

(Expired)

Otsuka
Abilify US8017615

(Pediatric)

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Dec 16, 2024

(Expired)

Otsuka
Abilify Maintena Kit US7807680 Controlled release sterile injectable aripiprazole formulation and method Oct 19, 2024

(Expired)

Otsuka Pharm Co Ltd
Abilify Maintena Kit US8030313 Controlled release sterile injectable aripiprazole formulation and method Oct 19, 2024

(Expired)

Otsuka Pharm Co Ltd
Abilify Maintena Kit US8722679 Controlled release sterile injectable aripiprazole formulation and method Oct 19, 2024

(Expired)

Otsuka Pharm Co Ltd
Abilify US7115587 Aripiprazole complex formulation and method Jul 21, 2024

(Expired)

Otsuka
Abilify US7550445 Aripiprazole complex formulation and method Jul 21, 2024

(Expired)

Otsuka
Abilify US8017615 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Jun 16, 2024

(Expired)

Otsuka
Abilify Mycite Kit US8017615 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Jun 16, 2024

(Expired)

Otsuka
Abilify US9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Dec 25, 2023

(Expired)

Otsuka
Abilify US9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Dec 25, 2023

(Expired)

Otsuka
Abilify Mycite Kit US9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Dec 25, 2023

(Expired)

Otsuka
Abilify Asimtufii US8338428 Methods for administering aripiprazole Aug 06, 2023

(Expired)

Otsuka
Abilify Asimtufii US8759351 Methods for administering aripiprazole Aug 06, 2023

(Expired)

Otsuka
Abilify Maintena Kit US8338428 Methods for administering aripiprazole Aug 06, 2023

(Expired)

Otsuka Pharm Co Ltd
Abilify Maintena Kit US8759351 Methods for administering aripiprazole Aug 06, 2023

(Expired)

Otsuka Pharm Co Ltd
Abilify US8580796

(Pediatric)

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Mar 25, 2023

(Expired)

Otsuka
Abilify US8642760

(Pediatric)

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Mar 25, 2023

(Expired)

Otsuka
Abilify US6977257

(Pediatric)

Aripiprazole oral solution Oct 24, 2022

(Expired)

Otsuka
Abilify US8580796 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Sep 25, 2022

(Expired)

Otsuka
Abilify US8642760 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Sep 25, 2022

(Expired)

Otsuka
Abilify US9359302 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Sep 25, 2022

(Expired)

Otsuka
Abilify Maintena Kit US8993761 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Sep 25, 2022

(Expired)

Otsuka Pharm Co Ltd
Abilify Mycite Kit US8580796 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Sep 25, 2022

(Expired)

Otsuka
Abilify Mycite Kit US8642760 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Sep 25, 2022

(Expired)

Otsuka
Abilify Mycite Kit US9359302 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Sep 25, 2022

(Expired)

Otsuka
Abilify US8642600

(Pediatric)

Method of treating autism Jul 28, 2022

(Expired)

Otsuka
Abilify US8642600

(Pediatric)

Method of treating autism Jul 28, 2022

(Expired)

Otsuka
Abilify US6977257 Aripiprazole oral solution Apr 24, 2022

(Expired)

Otsuka
Abilify US7053092 5-HT1a receptor subtype agonist Jan 28, 2022

(Expired)

Otsuka
Abilify US7053092 5-HT1a receptor subtype agonist Jan 28, 2022

(Expired)

Otsuka
Abilify US8642600 Method of treating autism Jan 28, 2022

(Expired)

Otsuka
Abilify US8642600 Method of treating autism Jan 28, 2022

(Expired)

Otsuka
Abilify US9089567 Method of treating cognitive impairments and schizophrenias Jan 28, 2022

(Expired)

Otsuka
Abilify Maintena Kit US9089567 Method of treating cognitive impairments and schizophrenias Jan 28, 2022

(Expired)

Otsuka Pharm Co Ltd
Abilify Mycite Kit US7053092 5-HT1a receptor subtype agonist Jan 28, 2022

(Expired)

Otsuka
Abilify Mycite Kit US9089567 Method of treating cognitive impairments and schizophrenias Jan 28, 2022

(Expired)

Otsuka
Abilify US8518421

(Pediatric)

Flashmelt oral dosage formulation Jul 24, 2021

(Expired)

Otsuka
Abilify US8518421 Flashmelt oral dosage formulation Jan 24, 2021

(Expired)

Otsuka
Abilify US9358207 Flashmelt oral dosage formulation Apr 12, 2020

(Expired)

Otsuka
Abilify US5006528

(Pediatric)

Carbostyril derivatives Apr 20, 2015

(Expired)

Otsuka
Abilify US5006528

(Pediatric)

Carbostyril derivatives Apr 20, 2015

(Expired)

Otsuka
Abilify Maintena Kit US5006528 Carbostyril derivatives Apr 20, 2015

(Expired)

Otsuka Pharm Co Ltd
Abilify Maintena Kit US5006528

(Pediatric)

Carbostyril derivatives Apr 20, 2015

(Expired)

Otsuka Pharm Co Ltd
Abilify US5006528 Carbostyril derivatives Oct 20, 2014

(Expired)

Otsuka
Abilify US5006528 Carbostyril derivatives Oct 20, 2014

(Expired)

Otsuka
Abilify Maintena Kit US5006528 Carbostyril derivatives Oct 20, 2014

(Expired)

Otsuka Pharm Co Ltd



Aripiprazole's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Aripiprazole:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Aripiprazole has 2 clinical trials that have been verified in 2024. Out of these 2, 1 trial is in PHASE4.

Title Lead Sponsor Collaborators Status Phases
Aripiprazole in Body Focused Repetitive Behaviors University of Chicago NOT YET RECRUITING
(Jul, 2024)
PHASE2
VA Aripiprazole vs Esketamine for Treatment Resistant Depression VA Office of Research and Development WITHDRAWN
(Jan, 2024)
PHASE4
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia Otsuka Pharmaceutical Europe Ltd H. Lundbeck A/S UNKNOWN
(Apr, 2019)
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders Indiana University National Institute of Mental Health (NIMH), Bristol-Myers Squibb COMPLETED
(Mar, 2018)
PHASE3
Comparison of Aripiprazole Versus Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI University of British Columbia Bristol-Myers Squibb COMPLETED
(May, 2016)
Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. Otsuka Pharmaceutical Development & Commercialization, Inc. TERMINATED
(Jan, 2016)
PHASE3
Aripiprazole for the Augmentation of Antidepressant Therapy Taiwan Otsuka Pharm. Co., Ltd COMPLETED
(May, 2014)
PHASE4
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical COMPLETED
(Feb, 2013)
PHASE3
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical COMPLETED
(Aug, 2008)
PHASE4
Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders Otsuka Pharmaceutical Development & Commercialization, Inc. COMPLETED
(Sep, 2007)
PHASE2, PHASE3


Aripiprazole Generic API Manufacturers

Several generic applications have been filed for Aripiprazole. The first generic version for Aripiprazole was by Teva Pharmaceuticals Usa and was approved on Apr 28, 2015. And the latest generic version is by Mylan Pharmaceuticals Inc and was approved on Dec 3, 2024.

Given below is the list of companies who have filed for Aripiprazole generic, along with the locations of their manufacturing plants worldwide.