Alkermes Company Profile

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ALKERMES has six approved drugs.

There are twenty-eight US patents protecting ALKERMES drugs.

There are two hundred and twenty-four patent family members on ALKERMES drugs in thirty-four countries and thirteen supplementary protection certificates in eight countries.

International Patents:	224
US Patents:	28
Tradenames:	6
Ingredients:	5
NDAs:	6
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

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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 INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	No	8,431,576	See Plans and Pricing		Y		See Plans and Pricing
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No	9,119,848	See Plans and Pricing		Y		See Plans and Pricing
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021		RX	Yes	No	11,241,425	See Plans and Pricing				See Plans and Pricing
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	11,185,541	See Plans and Pricing				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

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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	6,379,704	See Plans and Pricing
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021	7,956,187	See Plans and Pricing
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	5,792,477	See Plans and Pricing
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	7,799,345	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	17C1058	France	See Plans and Pricing	PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
1675573	2014C/029	Belgium	See Plans and Pricing	PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
2316456	1790064-8	Sweden	See Plans and Pricing	PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
2316456	2017/059	Ireland	See Plans and Pricing	PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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