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VASCEPA Drug Profile

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Which patents cover Vascepa, and what generic alternatives are available?

Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are twenty-five patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and sixty-one patent family members in forty-one countries.

The generic ingredient in VASCEPA is icosapent ethyl. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the icosapent ethyl profile page.

Summary for VASCEPA

International Patents:	161
US Patents:	25
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	26
Clinical Trials:	5
Patent Applications:	192
Drug Prices:	see details
DailyMed Link:	VASCEPA at DailyMed

Synonyms for VASCEPA

(5Z,8Z,11Z,14Z,17Z)-5,8,11,14,17-Eicosapentaenoic Acid Ethyl Ester

(5Z,8Z,11Z,14Z,17Z)-Eicosapentaenoic acid ethyl ester

(5Z,8Z,11Z,14Z,17Z)-Eicosapetaenoic acid ethyl ester

(all-Z)-5,8,11,14,17-Eicosapentaenoic acid ethyl ester

1606AH

5-8-11-14-17-all cis-eicosapentaenoic acid ethyl ester

5,8,11,14,17-Eicosapentaenoic acid, (5Z,8Z,11Z,14Z,17Z)-(9CI)

5,8,11,14,17-Eicosapentaenoic acid, (all-Z)-(8CI)

5,8,11,14,17-Eicosapentaenoic acid, ethyl ester, (all-Z)-

5Z,8Z,11Z,14Z,17Z-Eicosapentaenoic acid, ethyl ester

6GC8A4PAYH

73310-10-8

86227-47-6

AB01563352_01

AKOS025295847

all cis-5,8,11,14,17-Eicosapentaenoic Acid Ethyl Ester

all-cis-ethyl 5,8,11,14,17-icosapentaenoate

AMR 101

AMR-101

AMR101

AN-5630

C16184

C22H34O2

CCG-213714

CHEBI:80366

CHEBI:84883

CHEMBL2095209

cis-5,8,11,14,17-Eicosapentaenoic acid ethyl ester

cis-Eicosapentaenoic acid ethyl ester

CS-5304

D01892

D0G2MW

D0LW5J

D0Q8BT

DB08887

E-EPA

E0442

E0853

Eicosapentaenoic acid (ethyl ester)

Eicosapentaenoic acid ethyl ester

Eicosapentaenoic acid, ethyl ester

EICOSAPENTAENOICACIDETHYLESTER(EPAEE)(SG)

EPA ethyl ester

EPA-E

Epadel

Epadel (TN)

Epadel S (TN)

Ethyl (5Z,8Z,11Z,14Z,17Z)-eicosa-5,8,11,14,17-pentaenoate

ethyl (5Z,8Z,11Z,14Z,17Z)-eicosapentaenoate

ethyl (5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenoate

ethyl (5Z,8Z,11Z,14Z,17Z)-icosapentaenoate

Ethyl (all cis)-5,8,11,14,17-icosapentaenoate

Ethyl all cis-5,8,11,14,17-Eicosapentaenoate

Ethyl all cis-5,8,11,14,17-Icosapentaenoate

ethyl all-cis-5,8,11,14,17-icosapentaenoate

Ethyl all-cis-5,8,11,14,17-icosapentaenoic acid

ethyl eicosapent

ethyl eicosapentaenoate

Ethyl eicosapentaenoic acid

Ethyl EPA

Ethyl ester(all-Z)-5,8,11,14,17-Eicosapentaenoic acid

ethyl icosapentaenoate

ethyl icosapentate

ETHYL ICOSAPENTATE (Benazolin-Ethyl)

Ethyl icosapentate (JP17)

Ethyl icosapentate [JAN]

Ethyl icosapentate, JAN

ethyl-eicosapent

ethyl-eicosapentaenoic acid

ethyl-EPA

GTPL7441

HMS2094K19

HY-B0747

ICOSAPENT ETHYL

Icosapent ethyl (USAN)

Icosapent ethyl [USAN]

icosapentate

LMFA07010877

LS-63776

MFCD00673476

MND 21

MolPort-006-393-913

NSC-759597

NSC759597

OMEGA-3-ACID ESTERS (EPA shown)

Pharmakon1600-01300030

SBI-0206684.P002

SCHEMBL123305

SR-05000002595

SR-05000002595-1

SSQPWTVBQMWLSZ-AAQCHOMXSA-N

Timnodonic acid ethyl ester

UNII-6GC8A4PAYH

UNII-D87YGH4Z0Q component SSQPWTVBQMWLSZ-AAQCHOMXSA-N

Vascepa (TN)

ZINC3785276

US Patents and Regulatory Information for VASCEPA

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		RX	Yes	No
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017		RX	Yes	No
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017		RX	Yes	No			Y	Y
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017		RX	Yes	No

Paragraph IV (Patent) Challenges for VASCEPA

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

Non-Orange Book US Patents for VASCEPA

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
8,663,662	Stable pharmaceutical composition and methods of using same
8,613,945	Stable pharmaceutical composition and methods of using same
7,119,118	Highly purified ethyl EPA and other EPA derivatives for treatment of huntington's disease
9,138,415	Stable pharmaceutical composition and methods of using same

International Patents for VASCEPA

Country	Document Number	Estimated Expiration
China	104042617
Slovenia	2395991
South Korea	20120000109
Russian Federation	2538691

Supplementary Protection Certificates for VASCEPA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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: