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Last Updated: February 22, 2024

ARISTADA INITIO KIT Drug Patent Profile


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Which patents cover Aristada Initio Kit, and what generic alternatives are available?

Aristada Initio Kit is a drug marketed by Alkermes Inc and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in ARISTADA INITIO KIT 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 Initio Kit

Aristada Initio Kit 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 September 8, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ARISTADA INITIO KIT
International Patents:96
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:ARISTADA INITIO KIT at DailyMed
Drug patent expirations by year for ARISTADA INITIO KIT
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ARISTADA INITIO KIT
Generic Entry Date for ARISTADA INITIO KIT*:
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 INITIO KIT

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 INITIO KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ARISTADA INITIO KIT

US Patents and Regulatory Information for ARISTADA INITIO KIT

ARISTADA INITIO KIT is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARISTADA INITIO KIT 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 INITIO KIT

Aripiprazole prodrug compositions
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

Aripiprazole prodrug composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Aripiprazole prodrug composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole prodrug composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  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 INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
>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 INITIO KIT

When does loss-of-exclusivity occur for ARISTADA INITIO KIT?

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

Australia

Patent: 15306198
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017002926
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 57762
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6794251
Estimated Expiration: ⤷  Try a Trial

Patent: 2494492
Estimated Expiration: ⤷  Try a Trial

Patent: 2641785
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0190642
Estimated Expiration: ⤷  Try a Trial

Patent: 0211271
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 21594
Estimated Expiration: ⤷  Try a Trial

Patent: 24625
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 82958
Estimated Expiration: ⤷  Try a Trial

Patent: 08196
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 82958
Estimated Expiration: ⤷  Try a Trial

Patent: 08196
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 43169
Estimated Expiration: ⤷  Try a Trial

Patent: 55711
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0607
Estimated Expiration: ⤷  Try a Trial

Patent: 2079
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 71166
Estimated Expiration: ⤷  Try a Trial

Patent: 26167
Estimated Expiration: ⤷  Try a Trial

Patent: 57830
Estimated Expiration: ⤷  Try a Trial

Patent: 17524021
Estimated Expiration: ⤷  Try a Trial

Patent: 20007316
Estimated Expiration: ⤷  Try a Trial

Patent: 21059604
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 82958
Estimated Expiration: ⤷  Try a Trial

Patent: 08196
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 1417
Estimated Expiration: ⤷  Try a Trial

Patent: 17002029
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8914
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 82958
Estimated Expiration: ⤷  Try a Trial

Patent: 08196
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 82958
Estimated Expiration: ⤷  Try a Trial

Patent: 08196
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 05376
Estimated Expiration: ⤷  Try a Trial

Patent: 17108204
Estimated Expiration: ⤷  Try a Trial

Patent: 19134055
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 746
Estimated Expiration: ⤷  Try a Trial

Patent: 232
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 82958
Estimated Expiration: ⤷  Try a Trial

Patent: 08196
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 21270
Estimated Expiration: ⤷  Try a Trial

Patent: 84849
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1905694
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 INITIO KIT around the world.

Country Patent Number Title Estimated Expiration
Japan 2020007316 アリピプラゾールプロドラッグ組成物 (ARIPIPRAZOLE PRODRUG COMPOSITIONS) ⤷  Try a Trial
Poland 3182958 ⤷  Try a Trial
Canada 2957762 COMPOSITIONS DE PROMEDICAMENT D'ARIPIPRAZOLE (ARIPIPRAZOLE PRODRUG COMPOSITIONS) ⤷  Try a Trial
Slovenia 3508196 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARISTADA INITIO KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 300669 Netherlands ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 C300669 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Moodys
McKinsey
Express Scripts
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 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.