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Aripiprazole - Generic Drug Details

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Aripiprazole is the generic ingredient in four branded drugs marketed by Alembic Pharms Ltd, Amneal Pharms, Teva Pharms Usa, Aurobindo Pharma Ltd, Otsuka, Torrent Pharms Ltd, Hetero Labs Ltd V, Otsuka Pharm Co Ltd, Silarx Pharms Inc, Apotex Inc, and Alkermes Inc, and is included in nineteen NDAs. There are twenty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and thirty-two patent family members in fifty countries.

There are forty-one drug master file entries for aripiprazole. Thirty-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: aripiprazole

Tradenames:4
Patents:27
Applicants:11
NDAs:19
Drug Master File Entries: see list41
Suppliers / Packaging: see list32
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: aripiprazole

Tentative approvals for ARIPIPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL10MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL15MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL20MG

Clinical Trials for: aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL202101-005Apr 28, 2015RXNo<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002RXNo8,580,796*PED<disabled>Y<disabled>
Aurobindo Pharma Ltd
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL203908-003Oct 8, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: aripiprazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 20135,006,528*PED<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 20024,734,416<disabled>
Otsuka
ABILIFY
aripiprazole
INJECTABLE;INTRAMUSCULAR021866-001Sep 20, 20065,006,528*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: aripiprazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,030,3125-HT1A receptor subtype agonist<disabled in preview>
9,387,2075-HT1A receptor subtype agonist<disabled in preview>
8,623,874Method of treating neurodegenerative diseases<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: aripiprazole

Country Document Number Estimated Expiration
Peru10862002<disabled in preview>
Japan4401077<disabled in preview>
Israel158202<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ARIPIPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/039United Kingdom<disabled>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
00669Netherlands<disabled>PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
2014020Lithuania<disabled>PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
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