ABILIFY Drug Patent Profile

When do Abilify patents expire, and what generic alternatives are available?

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

This drug has ninety patent family members in thirty-four countries.

The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-nine 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 on April 28^th, 2015.

Summary for ABILIFY

International Patents:	90
US Patents:	2
Applicants:	2
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	159
Patent Applications:	6,225
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
Otsuka Pharmaceutical Development & Commercialization, Inc.	NA
Genuine Research Center, Egypt	Phase 1
P&C Labs, Egypt	Phase 1

See all ABILIFY clinical trials

Pharmacology for ABILIFY

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for ABILIFY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 ABILIFY

ABILIFY is protected by two US patents.

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		DISCN	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		DISCN	Yes	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		DISCN	Yes	No			Y

Expired US Patents for ABILIFY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-003	Jun 7, 2006

EU/EMA Drug Approvals for ABILIFY

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/003803Aripiprazole 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/000471Abilify 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/002755Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.	Authorised	no	no	no	2013-11-14

International Patents for ABILIFY

See the table below for patents covering ABILIFY around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112606
Norway	324606
Croatia	P20050149	ARIPIPRAZOLE COMPLEX FORMULATION AND METHOD

Supplementary Protection Certificates for ABILIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119

DrugChatter Q&A for ABILIFY

Can abilify cause compulsive behaviors?
Does abilify help as an add on for depression?
What are the long-term effects of taking Abilify?