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Generated: July 27, 2017
What is the competitive landscape for OTSUKA PHARM CO LTD, and what generic alternatives to OTSUKA PHARM CO LTD drugs are available?
OTSUKA PHARM CO LTD has three approved drugs.| Patents: | 12 |
| Tradenames: | 3 |
| Ingredients: | 3 |
| NDAs: | 3 |
| 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 | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-002 | Jul 10, 2015 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-003 | Jul 10, 2015 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| 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 | 202971-004 | Sep 29, 2014 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,053,092 | 5-HT1a receptor subtype agonist | ► Subscribe | |||||||||||||||||||||||||||
| 8,901,130 | Low hygroscopic aripiprazole drug substance and processes for the preparation | ► Subscribe | |||||||||||||||||||||||||||
| 8,703,772 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,722,680 | Method of treating neurodegenerative diseases | ► Subscribe | |||||||||||||||||||||||||||
| 8,680,105 | Method of treating down's syndrome | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | PI0609785 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1463191 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 328134 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 221536 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101574347 | ► 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.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2014 | Austria | ► Subscribe | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119 | ||||||||||||||||||||||||||
| 2014020 | Lithuania | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
| 0669 | Netherlands | ► Subscribe | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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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