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ABILIFY MAINTENA KIT Drug Profile
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When do Abilify Maintena Kit patents expire, and when can generic versions of Abilify Maintena Kit launch?
Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are ten patents protecting this drug.
This drug has two hundred and forty-three patent family members in thirty-eight countries.
The generic ingredient in ABILIFY MAINTENA KIT 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 Maintena Kit
A generic version of ABILIFY MAINTENA KIT was approved as aripiprazole by ALEMBIC PHARMS LTD on April 28th, 2015.
Summary for ABILIFY MAINTENA KIT
| International Patents: | 243 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 137 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,093 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ABILIFY MAINTENA KIT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABILIFY MAINTENA KIT |
| DailyMed Link: | ABILIFY MAINTENA KIT at DailyMed |
Recent Clinical Trials for ABILIFY MAINTENA KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Otsuka Beijing Research Institute | Phase 1 |
| Otsuka Pharmaceutical Co., Ltd. | Phase 4 |
| Chonbuk National University Hospital | Phase 4 |
US Patents and Regulatory Information for ABILIFY MAINTENA KIT
| 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 MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | Start Trial | 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 | No | Start Trial | Start Trial | Y | 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 MAINTENA KIT
| 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 | Start Trial | Start Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | Start Trial | Start Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | Start Trial | Start Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABILIFY MAINTENA KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1419776 | Start Trial |
| Denmark | 1927357 | Start Trial |
| Japan | H02191256 | Start Trial |
| South Africa | 200601385 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY MAINTENA KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0367141 | 300161 | Netherlands | Start Trial | 300161, 20091027, EXPIRES: 20141026 |
| 1675573 | 92427 | Luxembourg | Start Trial | PRODUCT NAME: ARIPIPRAZOLE |
| 1675573 | 122014000057 | Germany | Start Trial | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 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 |
