Abilify Drug Patent Profile
✉ Email this page to a colleague
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 thirty-seven patents protecting this drug and three Paragraph IV challenges.
This drug has ninety patent family members in thirty-four countries.
The generic ingredient in ABILIFY 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
A generic version of Abilify was approved as aripiprazole by ALEMBIC on April 28th, 2015.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for Abilify?
- What are the global sales for Abilify?
- What is Average Wholesale Price for Abilify?
Summary for Abilify
| International Patents: | 90 |
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 159 |
| Patent Applications: | 6,225 |
| 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 |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | NA |
| Genuine Research Center, Egypt | Phase 1 |
| P&C Labs, Egypt | Phase 1 |
Pharmacology for Abilify
| Drug Class | Atypical Antipsychotic |
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 two 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 | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | DISCN | Yes | No | 8,956,288 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-001 | Nov 13, 2017 | DISCN | Yes | No | 9,125,939 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | DISCN | Yes | No | 8,545,402 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | RX | Yes | No | 11,400,087 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | DISCN | Yes | No | 9,941,931 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | DISCN | Yes | No | 8,945,005 | ⤷ 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 | 11,400,087 | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | 4,734,416 | ⤷ Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | 9,387,182 | ⤷ Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | 9,359,302 | ⤷ Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | 7,053,092 | ⤷ Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | 9,387,182 | ⤷ Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-004 | Jun 7, 2006 | 9,359,302 | ⤷ Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | 9,387,182 | ⤷ Start 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/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 | |
| Sandoz GmbH | Aripiprazole Sandoz | aripiprazole | EMEA/H/C/004008Aripiprazole 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 |
|---|---|---|---|
| Cyprus | 1112606 | ⤷ Start Trial | |
| Norway | 324606 | ⤷ Start Trial | |
| Croatia | P20050149 | ARIPIPRAZOLE COMPLEX FORMULATION AND METHOD | ⤷ Start Trial |
| Spain | 479134 | ⤷ Start Trial | |
| Poland | 374798 | Preparat kompleksu aripiprazolu i sposób leczenia (ARIPIPRAZOLE COMPLEX FORMULATION AND METHOD) | ⤷ Start Trial |
| Norway | 336263 | ⤷ Start Trial | |
| Norway | 336679 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Abilify
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 300669 | Netherlands | ⤷ Start Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 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 | C00367141/01 | Switzerland | ⤷ Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0367141 | 300161 | Netherlands | ⤷ Start Trial | 300161, 20091027, EXPIRES: 20141026 |
| 0367141 | SPC/GB04/039 | United Kingdom | ⤷ Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
© Copyright 2002-2026 thinkBiotech LLC
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Links