Aripiprazole lauroxil - Generic Drug Details

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What are the generic sources for aripiprazole lauroxil and what is the scope of freedom to operate?

Aripiprazole lauroxil is the generic ingredient in two branded drugs marketed by Alkermes Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aripiprazole lauroxil has one hundred and eighty-six patent family members in twenty-nine countries.

There are three drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.

Summary for aripiprazole lauroxil

International Patents:	186
US Patents:	17
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	7
Patent Applications:	235
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aripiprazole lauroxil
What excipients (inactive ingredients) are in aripiprazole lauroxil?	aripiprazole lauroxil excipients list
DailyMed Link:	aripiprazole lauroxil at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aripiprazole lauroxil

Generic Entry Dates for aripiprazole lauroxil^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe Dosage: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
Generic Entry Dates for aripiprazole lauroxil^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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 aripiprazole lauroxil

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

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

See all aripiprazole lauroxil clinical trials

Pharmacology for aripiprazole lauroxil

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole lauroxil

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for aripiprazole lauroxil

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Glossary

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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	207533-002	Oct 5, 2015		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-001	Oct 5, 2015		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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 aripiprazole lauroxil

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Country	Patent Number	Title	Estimated Expiration
Argentina	077239		⤷ Subscribe
Slovenia	3508196		⤷ Subscribe
Israel	228298	תכשירי רוקחות המכילים אסטרים של סורביטאן (Pharmaceutical compositions comrising sorbitan esters)	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2010151689		⤷ Subscribe
Serbia	56352		⤷ Subscribe
European Patent Office	2445502	COMPOSÉS HÉTÉROCYCLIQUES DESTINÉS AU TRAITEMENT DE TROUBLES NEUROLOGIQUES ET PSYCHOLOGIQUES (HETEROCYCLIC COMPOUNDS FOR THE TREATMENT OF NEUROLOGICAL AND PSYCHOLOGICAL DISORDERS)	⤷ Subscribe
Mexico	371417		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for aripiprazole lauroxil

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