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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Julphar
Chubb
Dow
Express Scripts
Daiichi Sankyo
Mallinckrodt
Harvard Business School

Generated: July 15, 2018

DrugPatentWatch Database Preview

Aripiprazole lauroxil - Generic Drug Details

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What are the generic drug sources for aripiprazole lauroxil and what is the scope of aripiprazole lauroxil freedom to operate?

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

Aripiprazole lauroxil has seventy-seven patent family members in twenty-six countries.

There are forty-five drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.
Summary for aripiprazole lauroxil
International Patents:77
US Patents:6
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 45
Suppliers / Packagers: 1
Bulk Api Vendors: 10
Clinical Trials: 5
Patent Applications: 31
DailyMed Link:aripiprazole lauroxil at DailyMed
Synonyms for aripiprazole lauroxil
(7-(4-(4-(2,3-Dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquinolin-1(2H)-yl)methyl dodecanoate
[7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-2-oxo-3,4-dihydroquinolin-1-yl]methyl dodecanoate
[7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-2-oxo-3,4-dihydroquinolin-1(2H)-yl]methyl dodecanoate
1259305-29-7
AKOS030627657
ALKS 9070
ALKS 9072
Aripiprazol- Lauroxil
Aripiprazole lauroxil (USAN)
Aripiprazole lauroxil [USAN]
Aristada
Aristada (TN)
B786J7A343
CHEBI:90930
CHEMBL2219425
D10364
Dodecanoic acid [7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2-oxo-1(2H)-quinolinyl]methyl ester
Dodecanoic acid, (7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-2-oxo-1(2H)-quinolinyl)methyl ester
DTXSID60154997
MFCD26967976
RDC 3317
RDC-3317
SCHEMBL1044330
UNII-B786J7A343
ZINC95564895

US Patents and Regulatory Information for aripiprazole lauroxil

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;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
9,861,699 Pharmaceutical compositions having improved storage stability ➤ Sign Up
9,351,976 Pharmaceutical compositions comprising sorbitan esters ➤ Sign Up
8,686,009 Prodrugs of NH-acidic compounds ➤ Sign Up
9,102,618 Prodrugs of NH-acidic compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for aripiprazole lauroxil

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
427 Luxembourg ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE
C/GB04/039 United Kingdom ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Harvard Business School
Cantor Fitzgerald
Covington
Merck
Boehringer Ingelheim
Moodys
US Department of Justice
Farmers Insurance

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