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ABILIFY Drug Profile
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» See Plans and PricingWhich 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 fifty 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-one suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
US ANDA 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: | 129 |
| Clinical Trials: | 69 |
| Patent Applications: | 3,872 |
| 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 |
| DailyMed Link: | ABILIFY at DailyMed |
Recent Clinical Trials for ABILIFY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Los Angeles | Phase 4 |
| Alkermes, Inc. | 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;ORAL | aripiprazole | 021436 | 2006-11-15 |
| ABILIFY | TABLET, ORALLY DISINTEGRATING;ORAL | aripiprazole | 021729 | 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 Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Otsuka Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Otsuka Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | RX | Yes | Yes | Start Trial | Start Trial | 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 | INJECTABLE;INTRAMUSCULAR | 021866-001 | Sep 20, 2006 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | 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 |
|---|---|---|
| Iceland | 7208 | Start Trial |
| Israel | 153838 | Start Trial |
| Peru | 20040895 | Start Trial |
| Poland | 393601 | Start Trial |
| Poland | 360900 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1675573 | 300669 | Netherlands | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 0367141 | C00367141/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 1675573 | 92427 | Luxembourg | Start Trial | PRODUCT NAME: ARIPIPRAZOLE |
| 0367141 | 300161 | Netherlands | Start Trial | 300161, 20091027, EXPIRES: 20141026 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
