ABILIFY MAINTENA KIT Drug Patent Profile
✉ Email this page to a colleague
When do Abilify Maintena Kit patents expire, and when can generic versions of Abilify Maintena Kit launch?
Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and eighty-six patent family members in forty-one countries.
The generic ingredient in ABILIFY MAINTENA KIT 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 Maintena Kit
A generic version of ABILIFY MAINTENA KIT was approved as aripiprazole by ALEMBIC on April 28th, 2015.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ABILIFY MAINTENA KIT?
- What are the global sales for ABILIFY MAINTENA KIT?
- What is Average Wholesale Price for ABILIFY MAINTENA KIT?
Summary for ABILIFY MAINTENA KIT
International Patents: | 286 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 163 |
Clinical Trials: | 9 |
Patent Applications: | 4,280 |
Drug Prices: | Drug price information for ABILIFY MAINTENA KIT |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABILIFY MAINTENA KIT |
DailyMed Link: | ABILIFY MAINTENA KIT at DailyMed |
Recent Clinical Trials for ABILIFY MAINTENA KIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Otsuka Beijing Research Institute | Phase 1 |
Otsuka Pharmaceutical Co., Ltd. | Phase 4 |
Chonbuk National University Hospital | Phase 4 |
Paragraph IV (Patent) Challenges for ABILIFY MAINTENA KIT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ABILIFY MAINTENA KIT | Extended-release Injectable Suspension | aripiprazole | 300 mg/vial and 400 mg/vial | 202971 | 1 | 2021-12-20 |
US Patents and Regulatory Information for ABILIFY MAINTENA KIT
ABILIFY MAINTENA KIT is protected by twenty-two US patents.
Patents protecting ABILIFY MAINTENA KIT
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR 1 DISORDER
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Controlled release sterile injectable aripiprazole formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Controlled release sterile injectable aripiprazole formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Controlled release sterile injectable aripiprazole formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Methods for administering aripiprazole
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 IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Controlled release sterile injectable aripiprazole formulation and method
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 Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 MAINTENA KIT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ABILIFY MAINTENA KIT
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ABILIFY MAINTENA KIT
See the table below for patents covering ABILIFY MAINTENA KIT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1419776 | ⤷ Sign Up | |
Austria | 522200 | ⤷ Sign Up | |
China | 106420627 | ⤷ Sign Up | |
European Patent Office | 2340810 | Suspension injectable d'aripiprazole (Aripiprazole injectable suspension) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY MAINTENA KIT
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 | C01675573/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014 |
1675573 | 32/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119 |
1675573 | 122014000057 | Germany | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |