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Aripiprazole lauroxil - Generic Drug Details

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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 thirty-nine patent family members in twelve 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:6
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, 2015RXYesYes9,193,685► subscribeY ► subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-002Oct 5, 2015RXYesNo8,796,276► subscribe ► subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-001Oct 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
Canada2885196► subscribe
Taiwan201103912► subscribe
Japan2015529237► 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
427Luxembourg► subscribePRODUCT NAME: ARIPIPRAZOLE
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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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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