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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Novartis
UBS
McKesson
Mallinckrodt
Fish and Richardson
McKinsey
Cerilliant
Express Scripts
Citi

Generated: December 14, 2017

DrugPatentWatch Database Preview

Otsuka Pharm Company Profile

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What is the competitive landscape for OTSUKA PHARM, and what generic alternatives to OTSUKA PHARM drugs are available?

OTSUKA PHARM has four approved drugs.

There are twelve US patents protecting OTSUKA PHARM drugs.

There are two hundred and thirty-seven patent family members on OTSUKA PHARM drugs in thirty-seven countries and nine supplementary protection certificates in eight countries.

Summary for Otsuka Pharm

International Patents:237
US Patents:12
Tradenames:4
Ingredients:4
NDAs:4
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co LtdREXULTIbrexpiprazoleTABLET;ORAL205422-005Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co LtdREXULTIbrexpiprazoleTABLET;ORAL205422-005Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co LtdREXULTIbrexpiprazoleTABLET;ORAL205422-001Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Otsuka Pharm Co LtdREXULTIbrexpiprazoleTABLET;ORAL205422-006Jul 10, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Otsuka Pharm Co LtdREXULTIbrexpiprazoleTABLET;ORAL205422-003Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Otsuka Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013► Subscribe► Subscribe
Otsuka PharmBUSULFEXbusulfanINJECTABLE;INJECTION020954-001Feb 4, 1999► Subscribe► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014► Subscribe► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014► Subscribe► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013► Subscribe► Subscribe
Otsuka PharmBUSULFEXbusulfanINJECTABLE;INJECTION020954-001Feb 4, 1999► Subscribe► Subscribe
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Paragraph IV activity for OTSUKA PHARM drugs

Drugname Dosage Strength Tradename Submissiondate
busulfanInjection6 mg/mLBUSULFEX12/26/2012

Non-Orange Book Patents for Otsuka Pharm

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
9,359,302Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,623,874Method of treating neurodegenerative diseases► Subscribe
8,642,600Method of treating autism► Subscribe
8,901,130Low hygroscopic aripiprazole drug substance and processes for the preparation► Subscribe
8,604,041Method of treating panic disorder► Subscribe
8,426,423Method of treating Attention Deficit Hyper-Activity Disorder► Subscribe
8,642,760Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,952,013Controlled release sterile injectable aripiprazole formulation and method► Subscribe
8,680,105Method of treating down's syndrome► Subscribe
8,703,772Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► 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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International Patent Family for Otsuka Pharm Drugs

Country Document Number Estimated Expiration
Cyprus1110208► Subscribe
Poland225415► Subscribe
Spain2343219► Subscribe
European Patent Office1330249► Subscribe
Germany602004017342► Subscribe
Ukraine85235► Subscribe
Hong Kong1196128► Subscribe
Japan5300194► Subscribe
Russian Federation2007142023► Subscribe
Australia2002334413► 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 Certificates for Otsuka Pharm Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
2014020Lithuania► SubscribePRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
/2014Austria► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
C/GB04/039United Kingdom► SubscribePRODUCT 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
1675573/01Switzerland► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
9 5013-2014Slovakia► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
2014 00026Denmark► SubscribePRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Argus Health
Novartis
McKesson
Express Scripts
Teva
Colorcon
Dow
Moodys
Merck

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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