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Last Updated: September 25, 2022

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 patent family members in twenty-six 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:90
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 Generic Entry Opportunity 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
Alkermes, Inc.Phase 4
University of California, Los AngelesPhase 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 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 INITIO KIT

Aripiprazole prodrug compositions
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

Aripiprazole prodrug composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Aripiprazole prodrug composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Aripiprazole prodrug composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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 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 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 INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No 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 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: See Plans and Pricing

Brazil

Patent: 2017002926
Estimated Expiration: See Plans and Pricing

Canada

Patent: 57762
Estimated Expiration: See Plans and Pricing

China

Patent: 6794251
Estimated Expiration: See Plans and Pricing

Patent: 2494492
Estimated Expiration: See Plans and Pricing

Patent: 2641785
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0190642
Estimated Expiration: See Plans and Pricing

Patent: 0211271
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 21594
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 82958
Estimated Expiration: See Plans and Pricing

Patent: 08196
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 82958
Estimated Expiration: See Plans and Pricing

Patent: 08196
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 43169
Estimated Expiration: See Plans and Pricing

Patent: 55711
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0607
Estimated Expiration: See Plans and Pricing

Patent: 2079
Estimated Expiration: See Plans and Pricing

Japan

Patent: 71166
Estimated Expiration: See Plans and Pricing

Patent: 26167
Estimated Expiration: See Plans and Pricing

Patent: 17524021
Estimated Expiration: See Plans and Pricing

Patent: 20007316
Estimated Expiration: See Plans and Pricing

Patent: 21059604
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 82958
Estimated Expiration: See Plans and Pricing

Patent: 08196
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 1417
Estimated Expiration: See Plans and Pricing

Patent: 17002029
Estimated Expiration: See Plans and Pricing

Poland

Patent: 82958
Estimated Expiration: See Plans and Pricing

Patent: 08196
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 82958
Estimated Expiration: See Plans and Pricing

Patent: 08196
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 05376
Estimated Expiration: See Plans and Pricing

Patent: 17108204
Estimated Expiration: See Plans and Pricing

Patent: 19134055
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 746
Estimated Expiration: See Plans and Pricing

Patent: 232
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 82958
Estimated Expiration: See Plans and Pricing

Patent: 08196
Estimated Expiration: See Plans and Pricing

Spain

Patent: 21270
Estimated Expiration: See Plans and Pricing

Patent: 84849
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1905694
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 INITIO KIT around the world.

Country Patent Number Title Estimated Expiration
Spain 2639065 See Plans and Pricing
Taiwan 201103912 Prodrugs of NH-acidic compounds See Plans and Pricing
Australia 2019230014 Aripiprazole dosing strategy See Plans and Pricing
Croatia P20211271 See Plans and Pricing
>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 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
>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.