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Generated: September 19, 2018

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ARISTADA Drug Profile

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When do Aristada patents expire, and what generic alternatives are available?

Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. There are seven patents protecting this drug.

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

Drug patent expirations by year for ARISTADA
Synonyms for ARISTADA
(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
Aripiprazole lauroxil (USAN)
Aripiprazole lauroxil [USAN]
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 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 INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No ➤ 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 Y ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No ➤ 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
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 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
8,686,009 Prodrugs of NH-acidic compounds ➤ Sign Up
9,351,976 Pharmaceutical compositions comprising sorbitan esters ➤ Sign Up
9,102,618 Prodrugs of NH-acidic compounds ➤ Sign Up
9,861,699 Pharmaceutical compositions having improved storage stability ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ARISTADA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427 Luxembourg ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE
00669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Cipla
AstraZeneca
Julphar
Chubb
Citi
Chinese Patent Office
Covington
Deloitte

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