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 five patents protecting this drug.
This drug has two hundred and sixty-five 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-eight 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
International Patents: | 265 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ABILIFY ASIMTUFII |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABILIFY ASIMTUFII |
What excipients (inactive ingredients) are in ABILIFY ASIMTUFII? | ABILIFY ASIMTUFII excipients list |
DailyMed Link: | ABILIFY ASIMTUFII at DailyMed |
![ABILIFY ASIMTUFII drug patent expirations Drug patent expirations by year for ABILIFY ASIMTUFII](/p/graph/s/t/ABILIFY_ASIMTUFII-patent-expirations.png)
![Drug Prices for ABILIFY ASIMTUFII](/p/graph/drug-price/ABILIFY+ASIMTUFII.png)
Pharmacology for ABILIFY ASIMTUFII
Drug Class | Atypical Antipsychotic |
US Patents and Regulatory Information for ABILIFY ASIMTUFII
ABILIFY ASIMTUFII is protected by eight 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
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | 217006-001 | 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 | 217006-001 | 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 | |||
>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 | 217006-001 | 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 | 217006-002 | 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 | |
Sandoz GmbH | Aripiprazole Sandoz | aripiprazole | EMEA/H/C/004008 Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Sandoz 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 Sandoz 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 | 2015-08-20 | |
>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 |
---|---|---|---|
Poland | 230869 | ⤷ Sign Up | |
South Korea | 20210116702 | 주사용 제제 (INJECTABLE PREPARARION) | ⤷ Sign Up |
European Patent Office | 1927355 | Médicament à base d'aripiprazole (crystal F) de faible hygroscopie et son procédé de préparation (Low hygroscopic aripiprazole (crystal F) drug substance and processes for the preparation thereof) | ⤷ Sign Up |
Chile | 2010000405 | ⤷ Sign Up | |
Taiwan | 201900174 | Injectable preparation | ⤷ Sign Up |
Ukraine | 115444 | ІН'ЄКЦІЙНИЙ ПРЕПАРАТ (INJECTABLE PREPARATION) | ⤷ Sign Up |
Japan | 2006070045 | ARIPIPRAZOLE ANHYDRIDE CRYSTALS, METHODS FOR PRODUCING THEM AND PREPARATIONS CONTAINING THEM | ⤷ 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 | 2014C/029 | Belgium | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
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 | 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 |