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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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aripiprazole lauroxil has one hundred and forty-seven patent family members in twenty-eight countries.

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

Summary for aripiprazole lauroxil

International Patents:	147
US Patents:	13
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	6
Patent Applications:	175
What excipients (inactive ingredients) are in aripiprazole lauroxil?	aripiprazole lauroxil excipients list
DailyMed Link:	aripiprazole lauroxil at DailyMed

Recent Clinical Trials for aripiprazole lauroxil

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Alkermes, Inc.	Phase 4
Alkermes, Inc.	Phase 1

See all aripiprazole lauroxil clinical trials

US Patents and Regulatory Information for aripiprazole lauroxil

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			Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No			Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes				Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No

International Patents for aripiprazole lauroxil

Country	Patent Number	Estimated Expiration
Portugal	3508196
Serbia	56352
Japan	6138703
World Intellectual Property Organization (WIPO)	2010151711
Japan	2017524021

Supplementary Protection Certificates for aripiprazole lauroxil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
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
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115