Aripiprazole - Generic Drug Details
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What are the generic drug sources for aripiprazole and what is the scope of patent protection?
Aripiprazole
is the generic ingredient in eight branded drugs marketed by Xiamen Lp Pharm Co, 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, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in forty-four NDAs. There are sixty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Aripiprazole has nine hundred and one patent family members in forty-eight countries.
There are forty-nine drug master file entries for aripiprazole. Forty-nine suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for aripiprazole
International Patents: | 901 |
US Patents: | 63 |
Tradenames: | 8 |
Applicants: | 31 |
NDAs: | 44 |
Drug Master File Entries: | 49 |
Finished Product Suppliers / Packagers: | 49 |
Raw Ingredient (Bulk) Api Vendors: | 161 |
Clinical Trials: | 385 |
Patent Applications: | 6,865 |
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 |
---|---|
Instituto de Salud Carlos III | Phase 4 |
Consorcio Centro de Investigación Biomédica en Red (CIBER) | Phase 4 |
First Affiliated Hospital Xi'an Jiaotong University | N/A |
Generic filers with tentative approvals for ARIPIPRAZOLE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10MG | TABLET, ORALLY DISINTEGRATING; ORAL |
⤷ Sign Up | ⤷ Sign Up | 30MG | TABLET; ORALLY DISINTEGRATING |
⤷ Sign Up | ⤷ Sign Up | 20MG | 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 MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-001 | Nov 13, 2017 | 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 MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Breckenridge | ARIPIPRAZOLE | aripiprazole | TABLET;ORAL | 091279-005 | Jan 9, 2017 | DISCN | No | No | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-005 | Nov 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | ⤷ 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 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for aripiprazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3236524 | SOURCE D'ÉNERGIE INTÉGRÉE AU CORPS AYANT UNE ÉLECTRODE DE SURFACE ÉLEVÉE (IN-BODY POWER SOURCE HAVING HIGH SURFACE AREA ELECTRODE) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2013009777 | ⤷ Sign Up | |
Japan | 2016155872 | アリピプラゾールを有効成分とするケーキ状組成物が含有された医療用器具、及びアリピプラゾールを有効成分とするケーキ状組成物 (MEDICAL DEVICE CONTAINING CAKE-LIKE COMPOSITION COMPRISING ARIPIPRAZOLE AS ACTIVE INGREDIENT, AND CAKE-LIKE COMPOSITION COMPRISING ARIPIPRAZOLE AS ACTIVE INGREDIENT) | ⤷ Sign Up |
Canada | 2980571 | SYSTEME POUR LA GESTION DE CHAINE D'APPROVISIONNEMENT (SYSTEM FOR SUPPLY CHAIN MANAGEMENT) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aripiprazole
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1675573 | 300669 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
1675573 | 122014000057 | Germany | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOL; 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 | 92427 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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