AMARIN Company Profile

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AMARIN has two approved drugs.

There are sixty-three US patents protecting AMARIN drugs.

There are three hundred and sixty-two patent family members on AMARIN drugs in forty-six countries and twenty-three supplementary protection certificates in fifteen countries.

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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
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	10,894,028	⤷ Start Trial				⤷ Start Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	8,617,593	⤷ Start Trial				⤷ Start Trial
Amarin Pharms	AMEN	medroxyprogesterone acetate	TABLET;ORAL	083242-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	8,623,406	⤷ Start Trial				⤷ Start Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	10,786,478	⤷ Start Trial				⤷ Start Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	8,710,041	⤷ Start Trial				⤷ Start Trial
>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
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	8,188,146	⤷ Start Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	8,188,146	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Capsules	1 g	➤ Subscribe	2013-01-15
➤ Subscribe	Capsules	500 mg	➤ Subscribe	2017-08-29
➤ Subscribe	Capsules	1 g	➤ Subscribe	2016-07-26

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2443246	2190037-8	Sweden	⤷ Start Trial	PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
2022495	21C1045	France	⤷ Start Trial	PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246	2021C/538	Belgium	⤷ Start Trial	PRODUCT NAME: VAZKEPA - ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2022495	C202130051	Spain	⤷ Start Trial	PRODUCT NAME: ICOSAPENTO DE ETILO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1524; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1524; DATE OF FIRST AUTHORISATION IN EEA: 20210326
2443246	2021042	Norway	⤷ Start Trial	PRODUCT NAME: IKOSAPENTETYL; REG. NO/DATE: EU/1/20/1524 20210408
2443246	SPC/GB21/056	United Kingdom	⤷ Start Trial	PRODUCT NAME: ICOSAPENT ETHYL; REGISTERED: UK EU/1/20/1524(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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