Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 9, 2019

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Aripiprazole lauroxil - Generic Drug Details

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What are the generic sources for aripiprazole lauroxil and what is the scope of patent protection?

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

Aripiprazole lauroxil has one hundred and eighteen patent family members in twenty-seven countries.

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

Summary for aripiprazole lauroxil
International Patents:118
US Patents:10
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 49
Suppliers / Packagers: 1
Bulk Api Vendors: 14
Clinical Trials: 5
Patent Applications: 41
DailyMed Link:aripiprazole lauroxil at DailyMed
Recent Clinical Trials for aripiprazole lauroxil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alkermes, Inc.Phase 4
Alkermes, Inc.Phase 1
Alkermes, Inc.Phase 3

See all aripiprazole lauroxil clinical trials

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)
AS-35241
B786J7A343
BCP14993
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
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 207533-004 Jun 5, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-002 Oct 5, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for aripiprazole lauroxil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 92427 Luxembourg   Start Trial PRODUCT NAME: ARIPIPRAZOLE
1675573 300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141 SPC/GB04/039 United Kingdom   Start Trial 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
1675573 C300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 2014C/029 Belgium   Start Trial PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Merck
Harvard Business School
Johnson and Johnson
Medtronic

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.