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Last Updated: March 19, 2024

Aripiprazole lauroxil - Generic Drug Details


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What are the generic sources for aripiprazole lauroxil and what is the scope of 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 seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aripiprazole lauroxil has one hundred and seventy-eight patent family members in twenty-nine countries.

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

Summary for aripiprazole lauroxil
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aripiprazole lauroxil
Generic Entry Dates for aripiprazole lauroxil*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Generic Entry Dates for aripiprazole lauroxil*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for aripiprazole lauroxil

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

SponsorPhase
University of MiamiPhase 4
University of California, Los AngelesPhase 4
Alkermes, Inc.Phase 4

See all aripiprazole lauroxil clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for aripiprazole lauroxil

Country Patent Number Title Estimated Expiration
Japan 2012531434 ⤷  Try a Trial
Lithuania 3156056 ⤷  Try a Trial
Saudi Arabia 110310539 مركبات NH-الحمضية (NH-ACIDIC COMPOUNDS) ⤷  Try a Trial
Japan 2017048247 神経学的および精神的障害の治療のための複素環式化合物 (HETEROCYCLIC COMPOUNDS FOR TREATMENT OF NEUROLOGICAL AND PSYCHOLOGICAL DISORDERS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aripiprazole lauroxil

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

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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 verification 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.