Aripiprazole - Generic Drug Details
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What are the generic drug sources for aripiprazole and what is the scope of freedom to operate?
Aripiprazole
is the generic ingredient in seven branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in forty-two NDAs. There are sixty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Aripiprazole has eight hundred and ninety-nine patent family members in forty-eight countries.
There are forty-nine drug master file entries for aripiprazole. Forty-seven suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for aripiprazole
| International Patents: | 899 |
| US Patents: | 62 |
| Tradenames: | 7 |
| Applicants: | 29 |
| NDAs: | 42 |
| Drug Master File Entries: | 49 |
| Finished Product Suppliers / Packagers: | 47 |
| Raw Ingredient (Bulk) Api Vendors: | 161 |
| Clinical Trials: | 384 |
| Patent Applications: | 7,090 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for aripiprazole |
| Drug Sales Revenues: | Drug sales revenues for aripiprazole |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aripiprazole |
| What excipients (inactive ingredients) are in aripiprazole? | aripiprazole excipients list |
| DailyMed Link: | aripiprazole at DailyMed |
Recent Clinical Trials for aripiprazole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| All India Institute of Medical Sciences, Bhubaneswar | N/A |
| First Affiliated Hospital Xi'an Jiaotong University | N/A |
| First Affiliated Hospital of Chongqing Medical University | Phase 1/Phase 2 |
Generic filers with tentative approvals for ARIPIPRAZOLE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 30MG | TABLET; ORALLY DISINTEGRATING |
| ⤷ Try a Trial | ⤷ Try a Trial | 20MG | TABLET, ORALLY DISINTEGRATING; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 15MG | TABLET, ORALLY DISINTEGRATING; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for aripiprazole
| Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for aripiprazole
Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole
Paragraph IV (Patent) Challenges for ARIPIPRAZOLE
| 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 |
| 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 aripiprazole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-005 | Nov 13, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Breckenridge | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 091279-006 | Jan 9, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-005 | Nov 13, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 aripiprazole
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka | ABILIFY | aripiprazole | INJECTABLE;INTRAMUSCULAR | 021866-001 | Sep 20, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for aripiprazole
| 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 aripiprazole
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 337132 | SISTEMA DE COMUNICACION CON ACTIVACON REMOTA. (COMMUNICATION SYSTEM WITH REMOTE ACTIVATION.) | ⤷ Try a Trial |
| Israel | 225902 | ⤷ Try a Trial | |
| Taiwan | I637752 | ⤷ Try a Trial | |
| Russian Federation | 2259366 | АРИПИПРАЗОЛОВОЕ ЛЕКАРСТВЕННОЕ СРЕДСТВО С НИЗКОЙ ГИГРОСКОПИЧНОСТЬЮ И СПОСОБЫ ЕГО ПОЛУЧЕНИЯ (LOW HYGROSCOPICITY ARYPYPRAZOLE MEDICINAL AGENT AND METHODS FOR ITS PREPARING) | ⤷ Try a Trial |
| Argentina | 033485 | SUSTANCIA MEDICINAL DE ARIPIPRAZOL DE BAJA HIGROSCOPICIDAD Y PROCESO PARA LA PREPARACION DE LA MISMA | ⤷ Try a Trial |
| Canada | 3000257 | SOURCE D'ENERGIE INTEGREE AU CORPS AYANT UNE ELECTRODE DE ZONE DE SURFACE SUPERIEURE (IN-BODY POWER SOURCE HAVING HIGH SURFACE AREA ELECTRODE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aripiprazole
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | C300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | PA2014020 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 122014000057 | Germany | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 0367141 | SPC/GB04/039 | United Kingdom | ⤷ Try a Trial | 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 | 32/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119 |
| 1675573 | 300669 | Netherlands | ⤷ Try a Trial | 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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