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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 seventy-six patent family members in forty-nine countries.

The generic ingredient in ABILIFY is aripiprazole. There are forty-three drug master file entries for this compound. Forty 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
Bulk Api Vendors: see list94
Clinical Trials: see list24
Patent Applications: see list3,053
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ABILIFY at DailyMed

Pharmacology for Tradename: ABILIFY

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002RXYesNo8,017,615*PED► subscribeY► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002RXYesYes► subscribe► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNYesNo9,387,182► subscribe ► subscribe
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Expired Patents for Tradename: ABILIFY

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 20024,734,416► subscribe
Otsuka
ABILIFY
aripiprazole
INJECTABLE;INTRAMUSCULAR021866-001Sep 20, 20065,006,528*PED► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 20024,734,416► subscribe
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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
8,901,303Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► subscribe
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► subscribe
9,387,2075-HT1A receptor subtype agonist► subscribe
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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
Japan2007503460► subscribe
Poland206882► subscribe
Hong Kong1101550► subscribe
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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► subscribePRODUCT NAME: ARIPIPRAZOLE
0669Netherlands► subscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
00669Netherlands► subscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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