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ABILIFY Drug Profile

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Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in five NDAs. It is available from fourteen suppliers. There are twenty-three patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and sixty-nine patent family members in forty-nine countries.

The generic ingredient in ABILIFY is aripiprazole. There are forty-one drug master file entries for this compound. Thirty-two suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the aripiprazole profile page.

Summary for Tradename: ABILIFY

Patents:23
Applicants:2
NDAs:5
Suppliers / Packagers: see list14

Pharmacology for Tradename: ABILIFY

Clinical Trials for: ABILIFY

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002RXNo8,642,600*PED<disabled>Y<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002RXYes<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNNo9,387,182<disabled> <disabled>
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Expired Patents for Tradename: ABILIFY

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 20024,734,416<disabled>
Otsuka
ABILIFY
aripiprazole
INJECTABLE;INTRAMUSCULAR021866-001Sep 20, 20065,006,528*PED<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 20025,006,528*PED<disabled>
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Paragraph IV activity for: ABILIFY

Drugname Dosage Strength RLD Submissiondate
aripiprazoleOral Solution1 mg/mLAbilify12/20/2007
aripiprazoleOrally Disintegrating Tablets10 mg, 15 mg, 20 mg and 30 mgAbilify11/15/2006
aripiprazoleTablets2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mgAbilify11/15/2006

Non-Orange Book Patents for Tradename: ABILIFY

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
9,387,2075-HT1A receptor subtype agonist<disabled in preview>
8,999,952Aripiprazole complex formulation and method<disabled in preview>
8,993,761Low hygroscopic aripiprazole drug substance and processes for the preparation thereof<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 Tradename: ABILIFY

Country Document Number Estimated Expiration
Spain2265836<disabled in preview>
Germany60028536<disabled in preview>
China103751118<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: ABILIFY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427Luxembourg<disabled>PRODUCT NAME: ARIPIPRAZOLE
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
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