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ABILIFY MYCITE KIT Drug Profile

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When do Abilify Mycite Kit patents expire, and when can generic versions of Abilify Mycite Kit launch?

Abilify Mycite Kit is a drug marketed by Otsuka and is included in one NDA. There are thirty-one patents protecting this drug.

This drug has six hundred and fifty-six patent family members in forty-one countries.

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

US ANDA Litigation and Generic Entry Outlook for Abilify Mycite Kit

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

Summary for ABILIFY MYCITE KIT

International Patents:	656
US Patents:	31
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY MYCITE KIT
DailyMed Link:	ABILIFY MYCITE KIT at DailyMed

Recent Clinical Trials for ABILIFY MYCITE KIT

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

Sponsor	Phase
Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 4

See all ABILIFY MYCITE KIT clinical trials

Pharmacology for ABILIFY MYCITE KIT

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ABILIFY MYCITE KIT

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	207202-003	Nov 13, 2017		RX	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		RX	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		RX	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		RX	Yes	No			Y

International Patents for ABILIFY MYCITE KIT

Country	Patent Number	Estimated Expiration
Singapore	10201500851V
Singapore	184494
Russian Federation	2005140285
Taiwan	200426146
Australia	2012282772

Supplementary Protection Certificates for ABILIFY MYCITE KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 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	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE