Aripiprazole - Generic Drug Details

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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, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, Torrent, and Alkermes Inc, and is included in thirty-six NDAs. There are sixty 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 eighty-nine patent family members in fifty-seven countries.

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

Summary for aripiprazole

International Patents:	889
US Patents:	60
Tradenames:	6
Applicants:	22
NDAs:	36
Drug Master File Entries:	49
Suppliers / Packagers:	41
Bulk Api Vendors:	129
Clinical Trials:	347
Patent Applications:	6,281
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
DailyMed Link:	aripiprazole at DailyMed

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Drug Sales Revenue Trends for aripiprazole

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Recent Clinical Trials for aripiprazole

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Sponsor	Phase
Alen Greš	Early Phase 1
Shanghai Jiao Tong University School of Medicine	Phase 4
University of Colorado, Denver	Phase 2

See all aripiprazole clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE

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

Paragraph IV (Patent) Challenges for ARIPIPRAZOLE

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 aripiprazole

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka Pharm Co Ltd	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Otsuka Pharm Co Ltd	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Otsuka Pharm Co Ltd	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Otsuka Pharm Co Ltd	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		RX	Yes	No	Start Trial	Start Trial		Y		Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for aripiprazole

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002	Start Trial	Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002	Start Trial	Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002	Start Trial	Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-003	Jun 7, 2006	Start Trial	Start Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for aripiprazole

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Country	Patent Number	Estimated Expiration
Norway	333291	Start Trial
Germany	60327225	Start Trial
Norway	2014027	Start Trial
China	1463191	Start Trial
Singapore	10201500851V	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for aripiprazole

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	PA2014020	Lithuania	Start Trial	PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	300669	Netherlands	Start Trial	PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	122014000057	Germany	Start Trial	PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	2014C/029	Belgium	Start Trial	PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
0367141	SPC/GB04/039	United Kingdom	Start Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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