ABILIFY Drug Patent Profile
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Which patents cover Abilify, and what generic alternatives are available?
Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in seven NDAs. There are fifty patents protecting this drug and three Paragraph IV challenges.
This drug has three hundred and one patent family members in thirty-nine countries.
The generic ingredient in ABILIFY 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
A generic version of ABILIFY was approved as aripiprazole by ALEMBIC on April 28th, 2015.
Summary for ABILIFY
International Patents: | 301 |
US Patents: | 8 |
Applicants: | 2 |
NDAs: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 157 |
Clinical Trials: | 158 |
Patent Applications: | 5,009 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ABILIFY |
Drug Sales Revenues: | Drug sales revenues for ABILIFY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABILIFY |
What excipients (inactive ingredients) are in ABILIFY? | ABILIFY excipients list |
DailyMed Link: | ABILIFY at DailyMed |



Recent Clinical Trials for ABILIFY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Genuine Research Center, Egypt | Phase 1 |
P&C Labs, Egypt | Phase 1 |
University of Chicago | Phase 2 |
Pharmacology for ABILIFY
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for ABILIFY
Paragraph IV (Patent) Challenges for ABILIFY
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 ABILIFY
ABILIFY is protected by seven US patents.
Patents protecting ABILIFY
Aripiprazole complex formulation and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Carbostyril derivatives and mood stabilizers for treating mood disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
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 | 207202-004 | Nov 13, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | 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 ABILIFY
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-002 | Nov 15, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-004 | Jun 7, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-002 | Nov 15, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-002 | Nov 15, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ABILIFY
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
See the table below for patents covering ABILIFY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2279429 | АРИПИПРАЗОЛОВОЕ ЛЕКАРСТВЕННОЕ СРЕДСТВО С НИЗКОЙ ГИГРОСКОПИЧНОСТЬЮ И СПОСОБЫ ЕГО ПОЛУЧЕНИЯ (ARIPIPRAZOLE MEDICINAL AGENT OF LOW HYGROSCOPICITY AND METHODS FOR ITS PREPARING) | ⤷ Try a Trial |
Georgia, Republic of | P20063996 | ARIPIPRAZOLE COMPLEX FORMULATION AND USE THEREOF | ⤷ Try a Trial |
Spain | 486992 | ⤷ Try a Trial | |
China | 100335047 | ⤷ Try a Trial | |
Italy | 1119284 | DERIVATI CARBOSTIRILICI E PROCEDIMENTO PER LA LORO PREPARAZIONE | ⤷ Try a Trial |
South Korea | 100858852 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0367141 | C00367141/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
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 | 2014C/029 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
1675573 | 300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
1675573 | 92427 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE |
0367141 | C300161 | Netherlands | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |