Aripiprazole - Generic Drug Details

What are the generic drug sources for aripiprazole and what is the scope of patent protection?

Aripiprazole is the generic ingredient in seven branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Mylan, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in forty-three NDAs. There are sixty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aripiprazole has nine hundred patent family members in forty-eight countries.

There are forty-nine drug master file entries for aripiprazole. Forty-eight suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for aripiprazole

International Patents:	900
US Patents:	62
Tradenames:	7
Applicants:	30
NDAs:	43
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	385
Patent Applications:	5,831
Drug Prices:	Drug price trends for aripiprazole
Drug Sales Revenues:	Drug sales revenues for aripiprazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aripiprazole
What excipients (inactive ingredients) are in aripiprazole?	aripiprazole excipients list
DailyMed Link:	aripiprazole at DailyMed

See drug prices for aripiprazole

See drug sales revenues for aripiprazole

Recent Clinical Trials for aripiprazole

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4
Instituto de Salud Carlos III	Phase 4
All India Institute of Medical Sciences, Bhubaneswar	N/A

See all aripiprazole clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		30MG	TABLET; ORALLY DISINTEGRATING
		20MG	TABLET, ORALLY DISINTEGRATING; ORAL
		15MG	TABLET, ORALLY DISINTEGRATING; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for aripiprazole

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for aripiprazole

Antipsychotic Agents

Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ARIPIPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABILIFY MAINTENA KIT	Extended-release Injectable Suspension	aripiprazole	300 mg/vial and 400 mg/vial	202971	1	2021-12-20
ABILIFY	Oral Solution	aripiprazole	1 mg/mL	021713	1	2007-12-20
ABILIFY	Tablets	aripiprazole	2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg	021436	8	2006-11-15
ABILIFY	Orally Disintegrating Tablets	aripiprazole	10 mg, 15 mg, 20 mg and 30 mg	021729	1	2006-11-15

US Patents and Regulatory Information for aripiprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		RX	Yes	No			Y
Alembic	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	202101-002	Apr 28, 2015	AB	RX	No	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		RX	Yes	No			Y
Amneal Pharms	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	204838-005	Jun 17, 2016	AB	RX	No	No
Unichem	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	203025-006	Dec 1, 2021	AB	RX	No	No

Expired US Patents for aripiprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017

EU/EMA Drug Approvals for aripiprazole

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)	aripiprazole	EMEA/H/C/003803 Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.	Authorised	yes	no	no	2015-06-30
Otsuka Pharmaceutical Netherlands B.V.	Abilify	aripiprazole	EMEA/H/C/000471 Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.	Authorised	no	no	no	2004-06-04
Otsuka Pharmaceutical Netherlands B.V.	Abilify Maintena	aripiprazole	EMEA/H/C/002755 Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.	Authorised	no	no	no	2013-11-14
Accord Healthcare S.L.U.	Aripiprazole Accord	aripiprazole	EMEA/H/C/004021 Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.,	Authorised	yes	no	no	2015-11-15
Zentiva, k.s.	Aripiprazole Zentiva	aripiprazole	EMEA/H/C/003899 Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.	Authorised	yes	no	no	2015-06-25
Sandoz GmbH	Aripiprazole Sandoz	aripiprazole	EMEA/H/C/004008 Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.,	Authorised	yes	no	no	2015-08-20

International Patents for aripiprazole

Country	Patent Number	Title	Estimated Expiration
South Korea	102150605
Israel	175072	פורמולצית אריפיפראזול הניתנת להזרקה סטרילית בשחרור מבוקר המכילה חלקיקי אריפיפרזול בגודל ממוצע של 1-10 מיקרון, הניתנת פעם או פעמיים בחודש, הכוללת פורמולציה שעברה יבוש בהקפאה, תהליכים להכנתה ושימוש בה לטיפול בסכיזופרניה (Controlled release sterile injectable aripiprazole formulation comprising a particulate aripiprazole having a mean particle size of 1-10 microns, administered once or twice a month and comprising a freeze-dried formulation, method of their production and uses thereof in treating schizophrenia)
China	103751118
China	103827914	Mobile communication device, system, and method
Hungary	E045979
Japan	6689324
South Korea	20200064173	주사용 제제 (INJECTABLE PREPARARION)

Supplementary Protection Certificates for aripiprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	PA2014020	Lithuania		PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	122014000057	Germany		PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	32/2014	Austria		PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
0367141	SPC/GB04/039	United Kingdom		PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
1675573	239 5013-2014	Slovakia		PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
1675573	C20140014 00322	Estonia		PRODUCT NAME: ARIPIPRASOOL;REG NO/DATE: K(2013)8163 (LOPLIK) 19.11.2013
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115