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

Aripiprazole has eight hundred and thirty-five patent family members in fifty-two countries.

There are forty-nine drug master file entries for aripiprazole. Forty-six suppliers are listed for this compound.

Summary for aripiprazole

International Patents:	835
US Patents:	65
Tradenames:	6
Applicants:	24
NDAs:	37
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	373
Patent Applications:	5,259
Formulation / Manufacturing:	see details
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
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Phase 4
Vanderbilt University Medical Center	Phase 4
Tan Tock Seng Hospital	Phase 3

See all aripiprazole clinical trials

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
Aurobindo Pharma Ltd	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	203908-005	Oct 8, 2015	AB	RX	No	No
Boscogen	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	091279-004	Jan 9, 2017	AB	RX	No	No
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002	AB	RX	Yes	No

Expired US Patents for aripiprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002

International Patents for aripiprazole

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2774595	SYSTÈME INGURGITABLE MARQUEUR D'ÉVÉNEMENT, INTÉGRÉ À UN PRODUIT PHARMACEUTIQUE (INTEGRATED INGESTIBLE EVENT MARKER SYSTEM WITH PHARMACEUTICAL PRODUCT)
South Korea	101898964
South Korea	101754803

Supplementary Protection Certificates for aripiprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
1675573	CA 2014 00026	Denmark		PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119