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Serving leading biopharmaceutical companies globally:

Novartis
Covington
Mallinckrodt
QuintilesIMS
McKesson
Queensland Health
Julphar
US Army
AstraZeneca
Johnson and Johnson

Generated: November 18, 2017

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ARISTADA Drug Profile

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What is the patent landscape for Aristada, and when can generic versions of Aristada launch?

Aristada is a drug marketed by Alkermes Inc and is included in one NDA. There are six patents protecting this drug.

This drug has sixty-five patent family members in twenty-five countries and four supplementary protection certificates in three countries.

The generic ingredient in ARISTADA is aripiprazole lauroxil. There are forty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.

Summary for ARISTADA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-001Oct 5, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-003Oct 5, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-004Jun 5, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-001Oct 5, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-001Oct 5, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-002Oct 5, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-003Oct 5, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-002Oct 5, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-003Oct 5, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-004Jun 5, 2017RXYesNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: ARISTADA

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
8,686,009Prodrugs of NH-acidic compounds► Subscribe
9,102,618Prodrugs of NH-acidic compounds► Subscribe
9,351,976Pharmaceutical compositions comprising sorbitan esters► 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 Tradename: ARISTADA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2014080285► Subscribe
European Patent Office2445343► Subscribe
European Patent Office3156056► Subscribe
Canada2766088► Subscribe
Canada2830511► Subscribe
Canada2885196► Subscribe
European Patent Office3119399► Subscribe
Taiwan201103912► Subscribe
Japan2017048247► Subscribe
Saudi Arabia3937► 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 Tradename: ARISTADA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
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
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chubb
Dow
Daiichi Sankyo
Baxter
Deloitte
AstraZeneca
QuintilesIMS
Cantor Fitzgerald
Citi

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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