ABILIFY MAINTENA KIT Drug Patent Profile
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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 six patents protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in thirty countries.
The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-nine 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.
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Summary for ABILIFY MAINTENA KIT
| International Patents: | 44 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 125 |
| Clinical Trials: | 9 |
| Patent Applications: | 6,225 |
| 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 fifteen US patents.
| 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 | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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 | 202971-002 | Feb 28, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| >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/003803Aripiprazole 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/000471Abilify 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/002755Maintenance 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/004021Aripiprazole 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/003899Aripiprazole 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 MAINTENA KIT
See the table below for patents covering ABILIFY MAINTENA KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | E411797 | ⤷ Start Trial | |
| Hong Kong | 1095266 | CONTROLLED RELEASE STERILE INJECTABLE ARIPIPRAZOLE FORMULATION AND METHOD | ⤷ Start Trial |
| Canada | 2910333 | ⤷ Start Trial | |
| Spain | 2343602 | ⤷ Start Trial | |
| Argentina | 033485 | SUSTANCIA MEDICINAL DE ARIPIPRAZOL DE BAJA HIGROSCOPICIDAD Y PROCESO PARA LA PREPARACION DE LA MISMA | ⤷ Start Trial |
| >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 | C01675573/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014 |
| 1675573 | 2014C/029 | Belgium | ⤷ Start Trial | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| 1675573 | 92427 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: ARIPIPRAZOLE |
| 0367141 | C300161 | Netherlands | ⤷ Start Trial | PRODUCT NAME: ARIPIPRAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/276/001-005;006-010;011-015;016-020 20040604 |
| 1675573 | CA 2014 00026 | Denmark | ⤷ Start Trial | PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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