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Last Updated: November 2, 2024

ABILIFY ASIMTUFII Drug Patent Profile


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

Abilify Asimtufii is a drug marketed by Otsuka and is included in one NDA. There are six patents protecting this drug.

This drug has two hundred and sixty-six patent family members in forty countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Abilify Asimtufii

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

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Summary for ABILIFY ASIMTUFII
Drug patent expirations by year for ABILIFY ASIMTUFII
Drug Prices for ABILIFY ASIMTUFII

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Pharmacology for ABILIFY ASIMTUFII

US Patents and Regulatory Information for ABILIFY ASIMTUFII

ABILIFY ASIMTUFII is protected by ten US patents.

Patents protecting ABILIFY ASIMTUFII

Injectable preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

Injectable preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Injectable preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

Injectable preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Methods for administering aripiprazole
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
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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 ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-002 Apr 27, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-002 Apr 27, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ASIMTUFII

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-002 Apr 27, 2023 ⤷  Sign Up ⤷  Sign Up
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 ⤷  Sign Up ⤷  Sign Up
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-002 Apr 27, 2023 ⤷  Sign Up ⤷  Sign Up
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ABILIFY ASIMTUFII

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) aripiprazole EMEA/H/C/003803
Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised yes no no 2015-06-30
Otsuka Pharmaceutical Netherlands B.V. Abilify aripiprazole EMEA/H/C/000471
Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised no no no 2004-06-04
Otsuka Pharmaceutical Netherlands B.V. Abilify Maintena aripiprazole EMEA/H/C/002755
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Authorised no no no 2013-11-14
Accord Healthcare S.L.U. Aripiprazole Accord aripiprazole EMEA/H/C/004021
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.,
Authorised yes no no 2015-11-15
Zentiva, k.s. Aripiprazole Zentiva aripiprazole EMEA/H/C/003899
Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised yes no no 2015-06-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ABILIFY ASIMTUFII

See the table below for patents covering ABILIFY ASIMTUFII around the world.

Country Patent Number Title Estimated Expiration
China 105832677 ⤷  Sign Up
Norway 20081631 ⤷  Sign Up
Poland 219564 ⤷  Sign Up
Norway 339816 ⤷  Sign Up
Ecuador SP034434 SUSTANCIA MEDICIANL DE ARIPIPRAZOL DE BAJA HIGROSCOPICIDAD Y PROCESO PARA LA PREPARACION DE LA MISMA ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABILIFY ASIMTUFII

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 92427 Luxembourg ⤷  Sign Up PRODUCT NAME: ARIPIPRAZOLE
0367141 SPC/GB04/039 United Kingdom ⤷  Sign Up 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
1675573 C300669 Netherlands ⤷  Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 2014C/029 Belgium ⤷  Sign Up PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573 300669 Netherlands ⤷  Sign Up 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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