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Last Updated: September 25, 2022

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 sixteen patents protecting this drug.

This drug has one hundred and twenty-three patent family members in twenty-seven 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 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.

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 thirteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARISTADA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Pharmaceutical compositions comprising sorbitan esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole formulations having increased injection speeds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

Aripiprazole formulations having increased injection speeds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION

Aripiprazole formulations having increased injection speeds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

Pharmaceutical compositions having improved storage stability
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole dosing strategy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Heterocyclic compounds for the treatment of neurological and psychological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Pharmaceutical compositions comprising sorbitan esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Pharmaceutical compositions having improved storage stability
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole formulations having increased injection speeds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION

Aripiprazole formulations having increased injection speeds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-004 Jun 5, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-003 Oct 5, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Patent: 20202577
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2016021535
Estimated Expiration: See Plans and Pricing

Canada

Patent: 43213
Estimated Expiration: See Plans and Pricing

China

Patent: 6132415
Estimated Expiration: See Plans and Pricing

Patent: 0368360
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 19399
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7517
Estimated Expiration: See Plans and Pricing

Patent: 5227
Estimated Expiration: See Plans and Pricing

Japan

Patent: 24110
Estimated Expiration: See Plans and Pricing

Patent: 96015
Estimated Expiration: See Plans and Pricing

Patent: 17507992
Estimated Expiration: See Plans and Pricing

Patent: 19123749
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 16012041
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 495
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3869
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 88233
Estimated Expiration: See Plans and Pricing

Patent: 16141055
Estimated Expiration: See Plans and Pricing

Patent: 19114425
Estimated Expiration: See Plans and Pricing

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 6524110 See Plans and Pricing
Israel 228298 תכשירי רוקחות המכילים אסטרים של סורביטאן (Pharmaceutical compositions comrising sorbitan esters) See Plans and Pricing
Australia 2015231278 Aripiprazole formulations having increased injection speeds See Plans and Pricing
European Patent Office 2685979 COMPOSITIONS PHARMACEUTIQUES INJECTABLES COMPRENANT UN AGENT ANTIPSYCHOTIQUE INSOLUBLE DANS L'EAU, DU LAURATE DE SORBITAN ET DU POLYSORBATE 20 (INJECTABLE PHARMACEUTICAL COMPOSITIONS COMPRISING A WATER-INSOLUBLE ANTI-PSYCHOTIC, SORBITAN LAURATE AND POLYSORBATE 20) See Plans and Pricing
China 112423754 阿立哌唑的给药策略 (ARIPIPRAZOLE DOSING STRATEGY) See Plans and Pricing
Spain 2639065 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARISTADA

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