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Alkermes Company Profile

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What is the competitive landscape for ALKERMES, and what generic alternatives to ALKERMES drugs are available?

ALKERMES has five approved drugs.

There are twenty-three US patents protecting ALKERMES drugs.

Summary for Alkermes

US Patents:	23
Tradenames:	5
Ingredients:	4
NDAs:	5
Patent Litigation for Alkermes:	See patent lawsuits for Alkermes
PTAB Cases with Alkermes as petitioner:	See PTAB cases with Alkermes as petitioner
PTAB Cases with Alkermes as patent owner:	See PTAB cases with Alkermes as patent owner

Drugs and US Patents for Alkermes

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	207533-003	Oct 5, 2015		RX	Yes	Yes	8,431,576			Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes	6,379,704		Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes	6,379,703		Y
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	No
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No	9,526,726		Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes	6,495,166		Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes	9,452,131

Expired US Patents for Alkermes

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	5,792,477
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,110,503
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,403,114
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	5,916,598

International Patents for Alkermes Drugs

Country	Document Number	Estimated Expiration
Czech Republic	20023848
Canada	2390284
Mexico	PA02011543
Australia	2015231278
Canada	2766088
Hungary	E033442
South Africa	200608563

Supplementary Protection Certificates for Alkermes Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
C/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
0669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
00669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Alkem
• Alkem Labs Ltd
• Alkermes
• Alkermes Gainesville
• Alkermes Inc