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Amarin Pharms Company Profile

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

AMARIN PHARMS has two approved drugs.

There are twenty-five US patents protecting AMARIN PHARMS drugs.

There are one hundred and forty-nine patent family members on AMARIN PHARMS drugs in forty-one countries and two supplementary protection certificates in one country.

Summary for Amarin Pharms

International Patents:	149
US Patents:	25
Tradenames:	2
Ingredients:	2
NDAs:	2

Drugs and US Patents for Amarin Pharms

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	202057-001	Jul 26, 2012		RX	Yes	Yes	8,415,335
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012		RX	Yes	Yes	8,617,593
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012		RX	Yes	Yes	8,367,652
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012		RX	Yes	Yes	8,617,594
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017		RX	Yes	No	8,188,146		Y	Y
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017		RX	Yes	No	8,518,929
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012		RX	Yes	Yes	8,546,372

Paragraph IV (Patent) Challenges for AMARIN PHARMS drugs

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

Non-Orange Book US Patents for Amarin Pharms

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,454,994	Stable pharmaceutical composition and methods of using same
9,138,415	Stable pharmaceutical composition and methods of using same
6,384,077	Highly purified EPA for treatment of schizophrenia and related disorders
8,680,144	Methods of treating mixed dyslipidemia
9,072,715	Stable pharmaceutical composition and methods of using same
8,691,871	Methods of treating mixed dyslipidemia
8,613,945	Stable pharmaceutical composition and methods of using same

International Patents for Amarin Pharms Drugs

Country	Document Number	Estimated Expiration
Denmark	2424356
World Intellectual Property Organization (WIPO)	2010127099
Denmark	2632810
New Zealand	627238
Czech Republic	20012695
Portugal	2424356
Mexico	2011011538

Supplementary Protection Certificates for Amarin Pharms Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
C0009	Belgium		PRODUCT NAME: CONCENTRE A 85 % D'OMEGA POLYINSATURES; QUANTITE CORRESPONDANT A :; ESTERS ETHYLIQUES D'ACIDE EICOSAPENTAENOIQUE (EPA) ET D'ACIDE DOCOSAHEXAENOIQUE (DHA); ALPHA TOCOPHEROL; NAT. REGISTRATION NO/DATE: NL 20819 19951002; FIRST REGISTRATION:

Similar Applicant Names

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

• Amarin Pharms