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Aripiprazole lauroxil - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for aripiprazole lauroxil?

Aripiprazole lauroxil is the generic ingredient in one branded drug marketed by Alkermes Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-four patent family members in seventeen countries.

There are forty-three drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.

Summary for Generic Name: aripiprazole lauroxil

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list43
Suppliers / Packagers: see list1
Bulk Api Vendors: see list3
Clinical Trials: see list75
Patent Applications: see list19
Drug Prices:see low prices
DailyMed Link:aripiprazole lauroxil at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-003Oct 5, 2015RXYesYes► Subscribe► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-003Oct 5, 2015RXYesYes9,034,867► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-002Oct 5, 2015RXYesNo9,193,685► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-001Oct 5, 2015RXYesNo9,193,685► SubscribeY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-002Oct 5, 2015RXYesNo9,526,726► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: aripiprazole lauroxil

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
9,102,618Prodrugs of NH-acidic compounds► Subscribe
8,686,009Prodrugs 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 Ingredient: aripiprazole lauroxil

Country Document Number Estimated Expiration
New Zealand597107► Subscribe
European Patent Office2685979► Subscribe
Japan2015071641► Subscribe
Canada2766088► Subscribe
Australia2013349388► 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: ARIPIPRAZOLE LAUROXIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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
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