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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Medtronic
McKinsey
Chinese Patent Office
Daiichi Sankyo
Fuji
Covington
Cipla

Generated: July 17, 2018

DrugPatentWatch Database Preview

ARISTADA Drug Profile

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When do Aristada patents expire, and when can generic versions of Aristada launch?

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

This drug has seventy-seven patent family members in twenty-six countries.

The generic ingredient in ARISTADA is aripiprazole lauroxil. There are forty-five 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
International Patents:77
US Patents:6
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 10
Clinical Trials: 3
Patent Applications: 24
DailyMed Link:ARISTADA at DailyMed
Drug patent expirations by year for ARISTADA
Generic Entry Opportunity Date for ARISTADA
Generic Entry Date for ARISTADA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 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
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
9,351,976 Pharmaceutical compositions comprising sorbitan esters ➤ Sign Up
9,861,699 Pharmaceutical compositions having improved storage stability ➤ 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 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:

Queensland Health
Fuji
McKesson
Deloitte
Julphar
Mallinckrodt
Johnson and Johnson
Cerilliant
Fish and Richardson

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