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ABILIFY Drug Profile

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Which patents cover Abilify, and what generic alternatives are available?

Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. There are forty-nine patents protecting this drug and three Paragraph IV challenges.

This drug has four hundred and twenty-eight patent family members in fifty-one countries.

The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Abilify

A generic version of ABILIFY was approved as aripiprazole by ALEMBIC PHARMS LTD on April 28^th, 2015.

Summary for ABILIFY

International Patents:	428
US Patents:	15
Applicants:	2
NDAs:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	69
Patent Applications:	4,111
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ABILIFY
Drug Sales Revenues:	Drug sales revenues for ABILIFY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY
What excipients (inactive ingredients) are in ABILIFY?	ABILIFY excipients list
DailyMed Link:	ABILIFY at DailyMed

See drug prices for ABILIFY

See drug sales revenues for ABILIFY

Recent Clinical Trials for ABILIFY

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Alkermes, Inc.	Phase 4
New York State Institute for Basic Research	Phase 2

See all ABILIFY clinical trials

Pharmacology for ABILIFY

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for ABILIFY

Tradename	Dosage	Ingredient	NDA	Submissiondate
ABILIFY	SOLUTION;ORAL	aripiprazole	021713	2007-12-20
ABILIFY	TABLET, ORALLY DISINTEGRATING;ORAL	aripiprazole	021729	2006-11-15
ABILIFY	TABLET;ORAL	aripiprazole	021436	2006-11-15

US Patents and Regulatory Information for ABILIFY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		RX	Yes	No			Y
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002	AB	RX	Yes	Yes
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes			Y
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002	AB	RX	Yes	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes			Y
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006		DISCN	Yes	No					Y

Expired US Patents for ABILIFY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-005	Jun 7, 2006
Otsuka	ABILIFY	aripiprazole	INJECTABLE;INTRAMUSCULAR	021866-001	Sep 20, 2006
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	021436-005	Nov 15, 2002

International Patents for ABILIFY

Country	Patent Number	Estimated Expiration
Russian Federation	2389490
Egypt	23943
China	100335047
Hungary	228864
Brazil	0313602
China	101579343
South Korea	0138529

Supplementary Protection Certificates for ABILIFY

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
0367141	C300161	Netherlands		PRODUCT NAME: ARIPIPRAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/276/001-005;006-010;011-015;016-020 20040604
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
0367141	300161	Netherlands		300161, 20091027, EXPIRES: 20141026
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
0367141	C00367141/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH