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Generated: June 25, 2017
Which patents cover Abilify, and when can generic versions of Abilify launch?
Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in five NDAs. There are twenty-three patents protecting this drug and three Paragraph IV challenges.| Patents: | 15 |
| Applicants: | 2 |
| NDAs: | 5 |
| Suppliers / Packagers: see list | 14 |
| Bulk Api Vendors: see list | 94 |
| Clinical Trials: see list | 58 |
| Patent Applications: see list | 3,165 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ABILIFY at DailyMed |
| Drug Class | Atypical Antipsychotic |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | AB | RX | Yes | No | 8,017,615*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-004 | Jun 7, 2006 | DISCN | Yes | No | 9,359,302 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | DISCN | No | No | 8,642,600*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | RX | Yes | No | 8,338,427 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | 4,734,416 | ► Subscribe | ||||||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | 5,006,528*PED | ► Subscribe | ||||||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | SOLUTION;ORAL | 021713-001 | Dec 10, 2004 | 5,006,528*PED | ► Subscribe | ||||||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | 5,006,528*PED | ► Subscribe | ||||||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | 5,006,528*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| aripiprazole | Oral Solution | 1 mg/mL | Abilify | 12/20/2007 |
| aripiprazole | Tablets | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | Abilify | 11/15/2006 |
| aripiprazole | Orally Disintegrating Tablets | 10 mg, 15 mg, 20 mg and 30 mg | Abilify | 11/15/2006 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,623,874 | Method of treating neurodegenerative diseases | ► Subscribe | |||||||||||||||||||||||||||
| 8,901,130 | Low hygroscopic aripiprazole drug substance and processes for the preparation | ► Subscribe | |||||||||||||||||||||||||||
| 8,703,773 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,901,303 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,722,680 | Method of treating neurodegenerative diseases | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 100530731 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1927355 | ► Subscribe | |||||||||||||||||||||||||||
| Malaysia | 140793 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 752214 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2389490 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 427 | Luxembourg | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLE | ||||||||||||||||||||||||||
| C/GB04/039 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 0669 | Netherlands | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
| 00669 | Netherlands | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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. thinkBiotech performs no independent verifification 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.
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