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Last Updated: February 29, 2024

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ARISTADA Drug Patent 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 seventeen patents protecting this drug.

This drug has one hundred and thirty patent family members in twenty-eight countries.

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

DrugPatentWatch® Generic Entry Outlook for Aristada

Aristada was eligible for patent challenges on October 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 19, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for ARISTADA
Drug Prices for ARISTADA

See drug prices for ARISTADA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for ARISTADA

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

SponsorPhase
University of California, Los AngelesPhase 4
Alkermes, Inc.Phase 4
Alkermes, Inc.Phase 3

See all ARISTADA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ARISTADA

US Patents and Regulatory Information for ARISTADA

ARISTADA is protected by fourteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARISTADA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ARISTADA

Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Pharmaceutical compositions comprising sorbitan esters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole formulations having increased injection speeds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

Aripiprazole formulations having increased injection speeds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION

Aripiprazole formulations having increased injection speeds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

Pharmaceutical compositions having improved storage stability
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole dosing strategy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole formulations having increased injection speeds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Pharmaceutical compositions comprising sorbitan esters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Pharmaceutical compositions having improved storage stability
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole formulations having increased injection speeds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

Aripiprazole formulations having increased injection speeds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
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 207533-003 Oct 5, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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 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 Y ⤷  Try a Trial
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 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
>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 ARISTADA

When does loss-of-exclusivity occur for ARISTADA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15231278
Estimated Expiration: ⤷  Try a Trial

Patent: 20202577
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2016021535
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 43213
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6132415
Estimated Expiration: ⤷  Try a Trial

Patent: 0368360
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 19399
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7517
Estimated Expiration: ⤷  Try a Trial

Patent: 5227
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 24110
Estimated Expiration: ⤷  Try a Trial

Patent: 96015
Estimated Expiration: ⤷  Try a Trial

Patent: 17507992
Estimated Expiration: ⤷  Try a Trial

Patent: 19123749
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 16012041
Estimated Expiration: ⤷  Try a Trial

Patent: 20010839
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 495
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3869
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 88233
Estimated Expiration: ⤷  Try a Trial

Patent: 16141055
Estimated Expiration: ⤷  Try a Trial

Patent: 19114425
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ARISTADA around the world.

Country Patent Number Title Estimated Expiration
Japan 6138703 ⤷  Try a Trial
European Patent Office 2445343 PROMÉDICAMENTS DE COMPOSÉS NH ACIDES (PRODRUGS OF NH-ACIDIC COMPOUNDS) ⤷  Try a Trial
Japan 6896015 ⤷  Try a Trial
Canada 3092335 STRATEGIE DE DOSAGE D'ARIPIPRAZOLE (ARIPIPRAZOLE DOSING STRATEGY) ⤷  Try a Trial
Croatia P20171415 ⤷  Try a Trial
New Zealand 762767 Aripiprazole formulations having increased injection speeds ⤷  Try a Trial
Taiwan 201103912 Prodrugs of NH-acidic compounds ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARISTADA

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