~ Buy the ARISTADA INITIO KIT (aripiprazole lauroxil) Drug Profile, 2024 PDF Report in the Report Store ~

ARISTADA INITIO KIT Drug Patent Profile

When do Aristada Initio Kit patents expire, 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-seven 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

Summary for ARISTADA INITIO KIT

International Patents:	97
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	ARISTADA INITIO KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ARISTADA INITIO KIT

NDA:

209830

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

Sponsor	Phase
Alkermes, Inc.	Phase 4
University of California, Los Angeles	Phase 4
Alkermes, Inc.	Phase 3

See all ARISTADA INITIO KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ARISTADA INITIO KIT

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for ARISTADA INITIO KIT

ARISTADA INITIO KIT is protected by eight US patents.

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

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
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	No			Y
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	No
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	No			Y
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	No				Y

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

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

Serbia

Slovenia

Spain

Turkey

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
Mexico	2017002029	COMPOSICIONES DE PROFARMACOS DE ARIPIPRAZOL. (ARIPIPRAZOLE PRODRUG COMPOSITIONS.)
New Zealand	728914	Aripiprazole prodrug compositions
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)
Serbia	58746	KOMPOZICIJE PROLEKA ARIPIPRAZOLA (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Turkey	201905694

Supplementary Protection Certificates for ARISTADA INITIO KIT

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