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 Mezofy, Opipza, Abilify Mycite Kit, Abilify Asimtufii, Abilify Maintena 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

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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.

1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Prescription	ORAL	AB	Dec 7, 2016
30MG	tablet	Prescription	ORAL	AB	Dec 7, 2016
20MG	tablet	Prescription	ORAL	AB	Dec 7, 2016
15MG	tablet	Prescription	ORAL	AB	Dec 7, 2016
10MG	tablet	Prescription	ORAL	AB	Dec 7, 2016
5MG	tablet	Prescription	ORAL	AB	Dec 7, 2016

2. AIPING PHARM INC

Aiping Pharmaceutical Inc has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Aiping Pharm Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Discontinued	ORAL	N/A	Jan 9, 2017
5MG	tablet	Discontinued	ORAL	N/A	Jan 9, 2017
30MG	tablet	Discontinued	ORAL	N/A	Jan 9, 2017
20MG	tablet	Discontinued	ORAL	N/A	Jan 9, 2017
15MG	tablet	Discontinued	ORAL	N/A	Jan 9, 2017
10MG	tablet	Discontinued	ORAL	N/A	Jan 9, 2017

3. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
30MG	tablet	Prescription	ORAL	AB	Sep 12, 2016
20MG	tablet	Prescription	ORAL	AB	Sep 12, 2016
15MG	tablet	Prescription	ORAL	AB	Sep 12, 2016
10MG	tablet	Prescription	ORAL	AB	Sep 12, 2016
5MG	tablet	Prescription	ORAL	AB	Sep 12, 2016
2MG	tablet	Prescription	ORAL	AB	Sep 12, 2016

Manufacturing Plant Locations
^New

Ajanta Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Ajanta Pharma Ltd as present at those locations.

Country

City

Firm Name

India

Aurangabad

Ajanta Pharma Ltd.

4. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Alembic.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
5MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
10MG (reference standard)	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 28, 2015
15MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 28, 2015
20MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
30MG	tablet	Prescription	ORAL	AB	Apr 28, 2015

Manufacturing Plant Locations
^New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country

City

Firm Name

India

Panchmahal	Alembic Pharmaceuticals Limited
Vadodara	Alembic Pharmaceuticals, Ltd
Vadodara	Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panelav	Alembic Pharmaceuticals Limited
Vadodara	Alembic Pharmaceuticals Ltd
Vadodara	Alembic Pharmaceuticals Limited
Panchmahal	Alembic Pharmaceuticals Limited (Units I and II)

5. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Prescription	ORAL	AB	Feb 21, 2019
2MG	tablet	Prescription	ORAL	AB	Feb 21, 2019
5MG	tablet	Prescription	ORAL	AB	Feb 21, 2019
15MG	tablet	Prescription	ORAL	AB	Feb 21, 2019
20MG	tablet	Prescription	ORAL	AB	Feb 21, 2019
30MG	tablet	Prescription	ORAL	AB	Feb 21, 2019

6. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 7 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML (reference standard)	solution	Prescription	ORAL	AA	Aug 14, 2015
2MG	tablet	Prescription	ORAL	AB	Jun 17, 2016
30MG	tablet	Prescription	ORAL	AB	Jun 17, 2016
20MG	tablet	Prescription	ORAL	AB	Jun 17, 2016
15MG	tablet	Prescription	ORAL	AB	Jun 17, 2016
10MG	tablet	Prescription	ORAL	AB	Jun 17, 2016
5MG	tablet	Prescription	ORAL	AB	Jun 17, 2016

7. APOTEX

Apotex Inc has filed for 7 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Apotex.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
20MG	tablet	Prescription	ORAL	AB	Jul 24, 2015
15MG	tablet	Prescription	ORAL	AB	Jul 24, 2015
10MG	tablet	Prescription	ORAL	AB	Jul 24, 2015
5MG	tablet	Prescription	ORAL	AB	Jul 24, 2015
2MG	tablet	Prescription	ORAL	AB	Jul 24, 2015
30MG	tablet	Prescription	ORAL	AB	Jul 24, 2015
1MG/ML	solution	Prescription	ORAL	AA	Sep 30, 2015

Manufacturing Plant Locations
^New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country

City

Firm Name

United States

Weston

Apotex Corp.

Canada

Richmond Hill	Apotex Inc.
North York	Apotex Inc.
Toronto	Apotex Inc.
Brantford	Apotex Pharmachem Inc.
Etobicoke	Apotex, Inc.
Winnipeg	Apotex Fermentation Inc.

India

Bangalore	Apotex Pharmachem India Pvt Ltd.
Bengaluru	Apotex Research Private Limited
Bangalore	Apotex Research Private Limited - Bioequivalence Centre

8. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Prescription	ORAL	AB	Oct 8, 2015
10MG	tablet	Prescription	ORAL	AB	Oct 8, 2015
30MG	tablet	Prescription	ORAL	AB	Oct 8, 2015
20MG	tablet	Prescription	ORAL	AB	Oct 8, 2015
15MG	tablet	Prescription	ORAL	AB	Oct 8, 2015
5MG	tablet	Prescription	ORAL	AB	Oct 8, 2015

Manufacturing Plant Locations
^New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country

City

Firm Name

India

Polepally, Mahaboob Nagar	Aurobindo Pharma Limited
Medchal	Aurobindo Pharma Ltd
Sangareddy	Aurobindo Pharma Limited
Bachupally	Aurobindo Pharma Limited

United States

East Windsor

Aurobindo Pharma USA Inc

9. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Aripiprazole. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Prescription	ORAL	AA	Jan 29, 2019

Manufacturing Plant Locations
^New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country

City

Firm Name

India

Medchal

Aurobindo Pharma Ltd

10. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Aripiprazole. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Prescription	ORAL	AA	Oct 25, 2022

11. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 1 generic for Aripiprazole. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Prescription	ORAL	AA	Nov 1, 2023

12. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
30MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
20MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
15MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
10MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
5MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
2MG	tablet	Prescription	ORAL	AB	Apr 28, 2015

13. LANNETT CO INC

Lannett Co Inc has filed for 1 generic for Aripiprazole. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Prescription	ORAL	AA	Aug 14, 2015

14. LUPIN

Lupin Inc has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Lupin.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
15MG	tablet	Prescription	ORAL	AB	Mar 18, 2024
20MG	tablet	Prescription	ORAL	AB	Mar 18, 2024
30MG	tablet	Prescription	ORAL	AB	Mar 18, 2024
10MG	tablet	Prescription	ORAL	AB	Mar 18, 2024
5MG	tablet	Prescription	ORAL	AB	Mar 18, 2024
2MG	tablet	Prescription	ORAL	AB	Mar 18, 2024

Manufacturing Plant Locations
^New

Lupin's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Lupin as present at those locations.

Country

City

Firm Name

India

Anakapalli District	Lupin Manufacturing Solutions Limited
Pithampur	Lupin Limited
Mandideep	Lupin Limited (Unit II)
Nagpur	Lupin Limited
Pithampur	Lupin Limited (Unit 1)
Navi Mumbai	LUPIN LIMITED
Vasco Da Gama	Lupin Limited
Pune	Lupin Bioresearch Center
Aurangabad	Lupin Ltd.
Tarapur, Thane	Lupin Limited
Pirangut	Lupin Limited
Dabhasa	LUPIN MANUFACTURING SOLUTIONS LIMITED
Mumbai	Lupin Limited
Mandideep	Lupin Limited

United States

Coral Springs	Lupin Research Inc
Baltimore	Lupin Pharmaceuticals Inc.

15. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
15MG	tablet	Prescription	ORAL	AB	Oct 7, 2016
2MG	tablet	Prescription	ORAL	AB	Oct 7, 2016
5MG	tablet	Prescription	ORAL	AB	Oct 7, 2016
10MG	tablet	Prescription	ORAL	AB	Oct 7, 2016
20MG	tablet	Prescription	ORAL	AB	Oct 7, 2016
30MG	tablet	Prescription	ORAL	AB	Oct 7, 2016

16. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Mylan.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
300MG/VIAL	for suspension, extended release	Discontinued	INTRAMUSCULAR	N/A	Dec 3, 2024
400MG/VIAL	for suspension, extended release	Discontinued	INTRAMUSCULAR	N/A	Dec 3, 2024

Manufacturing Plant Locations
^New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country

City

Firm Name

United States

Morgantown	Mylan Specialty, L.P.
San Carlos	Mylan Pharmaceuticals Inc.
Morgantown	MYLAN CONSUMER HEALTHCARE Inc.
Saint Albans	Mylan Technologies, Inc.
Greensboro	Mylan Pharmaceuticals Inc
Santa Barbara	Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Rockford	Mylan Institutional, Inc.

India

Sarigam	Mylan Laboratories Limited
Sinnar	Mylan Laboratories Limited
Hyderabad	Mylan Laboratories Limited
Pithampur, District Dhar	Mylan Laboratories Limited
Aurangabad	Mylan Laboratories Limited (FDF-2)
Anekal Taluk, Bangalore	Mylan Laboratories Limited
Hosur	Mylan Laboratories Limited
Bangalore	Mylan Laboratories Limited

Canada

Etobicoke

Mylan Pharmaceuticals ULC

Ireland

Inverin

Mylan Teoranta

17. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Discontinued	ORAL	N/A	Sep 19, 2018
5MG	tablet	Discontinued	ORAL	N/A	Sep 19, 2018
2MG	tablet	Discontinued	ORAL	N/A	Sep 19, 2018
30MG	tablet	Discontinued	ORAL	N/A	Sep 19, 2018
15MG	tablet	Discontinued	ORAL	N/A	Sep 19, 2018
20MG	tablet	Discontinued	ORAL	N/A	Sep 19, 2018

18. ORBION PHARMS

Orbion Pharmaceuticals Private Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Orbion Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
30MG	tablet	Prescription	ORAL	AB	May 23, 2017
20MG	tablet	Prescription	ORAL	AB	May 23, 2017
15MG	tablet, orally disintegrating	Prescription	ORAL	AB	Dec 11, 2017
10MG	tablet, orally disintegrating	Prescription	ORAL	AB	Dec 11, 2017
5MG	tablet	Prescription	ORAL	AB	May 23, 2017
2MG	tablet	Prescription	ORAL	AB	May 23, 2017

19. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
30MG	tablet	Prescription	ORAL	AB	Dec 4, 2017
5MG	tablet	Prescription	ORAL	AB	Dec 4, 2017
10MG	tablet	Prescription	ORAL	AB	Dec 4, 2017
15MG	tablet	Prescription	ORAL	AB	Dec 4, 2017
20MG	tablet	Prescription	ORAL	AB	Dec 4, 2017
2MG	tablet	Prescription	ORAL	AB	Dec 4, 2017

20. RUBICON

Rubicon Research Private Ltd has filed for 1 generic for Aripiprazole. Given below are the details of the strengths of this generic introduced by Rubicon.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Prescription	ORAL	AA	Oct 27, 2022

Manufacturing Plant Locations
^New

Rubicon's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Rubicon as present at those locations.

Country

City

Firm Name

United States

Geismar	Rubicon, LLC
Indianapolis	Rubicon Foods LLC

Canada

Concord

Rubicon Research Canada Limited

India

Ambarnath

Rubicon Research Private Limited

21. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
30MG	tablet	Prescription	ORAL	AB	Sep 29, 2016
20MG	tablet	Prescription	ORAL	AB	Sep 29, 2016
15MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 18, 2018
10MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 18, 2018
5MG	tablet	Prescription	ORAL	AB	Sep 29, 2016
2MG	tablet	Prescription	ORAL	AB	Sep 29, 2016

22. SQUARE PHARMS

Square Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Square Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet, orally disintegrating	Prescription	ORAL	AB	Aug 28, 2018
30MG	tablet, orally disintegrating	Prescription	ORAL	N/A	Aug 28, 2018
20MG	tablet, orally disintegrating	Prescription	ORAL	N/A	Aug 28, 2018
15MG	tablet, orally disintegrating	Prescription	ORAL	AB	Aug 28, 2018

23. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 3 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MG	tablet	Prescription	ORAL	AB	Oct 2, 2023
5MG	tablet	Prescription	ORAL	AB	Oct 2, 2023
2MG	tablet	Prescription	ORAL	AB	Oct 2, 2023

Manufacturing Plant Locations
^New

Sunshine's manufacturing plants are situated in 6 countries - United States, Peru, India, Thailand, China, Mozambique. Given below are the details of these plant locations as well as the firm names of Sunshine as present at those locations.

Country

City

Firm Name

United States

Portland	Sunshine Dairy Foods Management LLC
Doral	Sunshine Bottling Co, Inc.
Bridgeville	Sunshine Burger & Specialty Food Company, LLC
Evergreen	Sunshine Honey Bees LLC
Methuen	Sunshine International Foods, Inc.
Augusta	Sunshine Honey Inc.
Columbus	Sunshine Apiaries
Maumee	Sunshine Inc Of Nw Ohio
Jacksonville	Sunshine Peanut Company
Tupelo	Sunshine Mills, Inc.
Alhambra	Sunshine Bakery
Andrews	Sunshine Dairy, LLC
Dublin	Sunshine Mills, Inc
Glenwood Springs	Sunshine & Moons, LLC
Red Bay	Sunshine Mills aka World Pet Care
Halifax	Sunshine Mills, Inc.
Artesia	Sunshine Evergreen Inc.
North Las Vegas	Sunshine Fresh Nevada LLC
Indianapolis	SUNSHINE INTERNATIONAL LLC
Rochester	Sunshine Fund Raising Co.

Peru

Tambogrande

Sunshine Export S.A.C

India

Surat

Sunshine Global Hospital

Thailand

Tha Mai

Sunshine International

China

Dongguan

Sunshine Lake Pharma Co., Ltd

Mozambique

Boane

Sunshine Nut Limitada

24. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Discontinued	ORAL	N/A	Apr 28, 2015
5MG	tablet	Discontinued	ORAL	N/A	Apr 28, 2015
10MG	tablet	Discontinued	ORAL	N/A	Apr 28, 2015
15MG	tablet	Discontinued	ORAL	N/A	Apr 28, 2015
20MG	tablet	Discontinued	ORAL	N/A	Apr 28, 2015
30MG	tablet	Discontinued	ORAL	N/A	Apr 28, 2015

25. TORRENT

Torrent Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Torrent.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
5MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
10MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
15MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
20MG	tablet	Prescription	ORAL	AB	Apr 28, 2015
30MG	tablet	Prescription	ORAL	AB	Apr 28, 2015

Manufacturing Plant Locations
^New

Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.

Country

City

Firm Name

India

Pithampur	Torrent Pharmaceuticals Limited
Indrad	Torrent Pharmaceuticals Limited
Gandhi Nagar	Torrent Pharmaceuticals Limited
Bharuch	Torrent Pharmaceuticals Limited
Thanam	Torrent Pharmaceuticals Limited

United States

Basking Ridge	Torrent Pharma Inc.
Kalamazoo	Torrent Pharma Inc.

26. UNICHEM

Unichem Laboratories Ltd has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Unichem.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
30MG	tablet	Prescription	ORAL	AB	Dec 1, 2021
20MG	tablet	Prescription	ORAL	AB	Dec 1, 2021
5MG	tablet	Prescription	ORAL	AB	Dec 1, 2021
10MG	tablet	Prescription	ORAL	AB	Dec 1, 2021
15MG	tablet	Prescription	ORAL	AB	Dec 1, 2021
2MG	tablet	Prescription	ORAL	AB	Dec 1, 2021

Manufacturing Plant Locations
^New

Unichem's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Unichem as present at those locations.

Country

City

Firm Name

India

Kolhapur	Unichem Laboratories Limited
Mumbai	Unichem Laboratories Limited
Ghaziabad	Unichem Laboratories Ltd.
Pithampur	Unichem Laboratories Limited
District Raigad	Unichem Laboratories Ltd
Pilerne Bardez	Unichem Laboratories Limited

United States

East Brunswick	Unichem Pharmaceuticals USA Inc.
Hasbrouck Heights	Unichem Pharmaceuticals Usa Inc

27. VISTAPHARM LLC

Vistapharm Llc has filed for 1 generic for Aripiprazole. Given below are the details of the strengths of this generic introduced by Vistapharm Llc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Prescription	ORAL	AA	Dec 26, 2019

28. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Aripiprazole. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
30MG	tablet	Discontinued	ORAL	N/A	Jan 7, 2019
15MG	tablet	Discontinued	ORAL	N/A	Jan 7, 2019
20MG	tablet	Discontinued	ORAL	N/A	Jan 7, 2019
10MG	tablet	Discontinued	ORAL	N/A	Jan 7, 2019
5MG	tablet	Discontinued	ORAL	N/A	Jan 7, 2019
2MG	tablet	Discontinued	ORAL	N/A	Jan 7, 2019

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5. ALKEM LABS LTD

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7. APOTEX

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8. AUROBINDO PHARMA

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9. AUROBINDO PHARMA LTD

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10. CHARTWELL RX

11. HETERO LABS LTD III

12. HETERO LABS LTD V

13. LANNETT CO INC

14. LUPIN

Manufacturing Plant Locations New

15. MACLEODS PHARMS LTD

16. MYLAN

Manufacturing Plant Locations New

17. NORVIUM BIOSCIENCE

18. ORBION PHARMS

19. PRINSTON INC

20. RUBICON

Manufacturing Plant Locations New

21. SCIEGEN PHARMS INC

22. SQUARE PHARMS

23. SUNSHINE

Manufacturing Plant Locations New

24. TEVA PHARMS USA

25. TORRENT

Manufacturing Plant Locations New

26. UNICHEM

Manufacturing Plant Locations New

27. VISTAPHARM LLC

28. ZYDUS PHARMS

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