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ABILIFY Drug 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 six NDAs. There are forty-nine patents protecting this drug and three Paragraph IV challenges.
This drug has four hundred and twenty-eight patent family members in fifty-one countries.
The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-three 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 PHARMS LTD on April 28th, 2015.
Summary for ABILIFY
| International Patents: | 428 |
| US Patents: | 15 |
| Applicants: | 2 |
| NDAs: | 6 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 139 |
| Clinical Trials: | 69 |
| Patent Applications: | 4,111 |
| 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 |
|---|---|
| Alkermes, Inc. | Phase 4 |
| University of California, Los Angeles | Phase 4 |
| Rutgers, The State University of New Jersey | Phase 2 |
Pharmacology for ABILIFY
| Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for ABILIFY
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ABILIFY | SOLUTION;ORAL | aripiprazole | 021713 | 2007-12-20 |
| ABILIFY | TABLET, ORALLY DISINTEGRATING;ORAL | aripiprazole | 021729 | 2006-11-15 |
| ABILIFY | TABLET;ORAL | aripiprazole | 021436 | 2006-11-15 |
US Patents and Regulatory Information for ABILIFY
| 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 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | AB | RX | Yes | No | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABILIFY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20030870 | Start Trial |
| Netherlands | 7902514 | Start Trial |
| Argentina | 024384 | Start Trial |
| China | 104945321 | Start Trial |
| Peru | 20040895 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | 92427 | Luxembourg | Start Trial | PRODUCT NAME: ARIPIPRAZOLE |
| 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 |
| 0367141 | C00367141/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 1675573 | 2014C/029 | Belgium | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| 1675573 | 300669 | Netherlands | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
