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Last Updated: May 25, 2022

ABILIFY Drug Patent Profile


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Which patents cover Abilify, and what generic alternatives are available?

Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. There are fifty patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and fifty-three patent family members in forty-five countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Abilify

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

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Drug patent expirations by year for ABILIFY
Drug Prices for ABILIFY

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Drug Sales Revenue Trends for ABILIFY

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Recent Clinical Trials for ABILIFY

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

SponsorPhase
New Jersey Governor’s Council for Medical Research and Treatment of AutismPhase 2
Rutgers, The State University of New JerseyPhase 2
New Jersey Governor's Council for Medical Research and Treatment of AutismPhase 2

See all ABILIFY clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ABILIFY
Paragraph IV (Patent) Challenges for ABILIFY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ABILIFY Oral Solution aripiprazole 1 mg/mL 021713 1 2007-12-20
ABILIFY Tablets aripiprazole 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg 021436 8 2006-11-15
ABILIFY Orally Disintegrating Tablets aripiprazole 10 mg, 15 mg, 20 mg and 30 mg 021729 1 2006-11-15

US Patents and Regulatory Information for ABILIFY

ABILIFY is protected by eleven US patents.

Patents protecting ABILIFY

Aripiprazole oral solution
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

5-HT1a receptor subtype agonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Aripiprazole complex formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Method of treating cognitive impairments and schizophrenias
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Carbostyril derivatives and mood stabilizers for treating mood disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER

Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

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 207202-006 Nov 13, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 ABILIFY

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ABILIFY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0367141 C00367141/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
0367141 300161 Netherlands See Plans and Pricing 300161, 20091027, EXPIRES: 20141026
1675573 C300669 Netherlands See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca
Colorcon
Mallinckrodt

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