Is there a generic for Icosapent ethyl?

Yes. The FDA Orange Book lists 12 approved generic (ANDA) applications for Icosapent ethyl, referencing the brand VASCEPA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Icosapent ethyl?

VASCEPA (NDA 202057, AMARIN PHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Icosapent ethyl?

The Orange Book lists 61 patents against Icosapent ethyl products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Icosapent ethyl are approved?

Icosapent ethyl is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Icosapent ethyl

Icosapent ethyl: 1 brand, 12 generics; first approved Jul 26, 2012; generic available.

Generic available

Generic status & protection

Generic available: 12 ANDA applications approved.

Earliest patent expiry May 31, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 31, 2027

in 10 mo

Brand (NDA) products

Originator applications

VASCEPARLDRS
AMARIN PHARMSNDA 20205720122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
500MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB
500MG	CAPSULE	ORAL	Rx	AB

Generic (ANDA) products (12)

Abbreviated applications

ICOSAPENT ETHYL
AUROBINDO PHARMA LTDANDA 2189492026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
XIAMEN LP PHARM COANDA 2191562025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
TORRENTANDA 2189942024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
QILUANDA 2188992024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
ASCENT PHARMS INCANDA 21681120242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
HUMANWELL PURACAPANDA 21791920232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
ONESOURCE SPECIALTYANDA 21784420232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
ZYDUS LIFESCIENCESANDA 21765620232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
APOTEXANDA 2094372021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
TEVA PHARMS USAANDA 20952520202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
1GM CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
DR REDDYSANDA 20949920202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
500MG CAPSULE ORAL Rx AB
ICOSAPENT ETHYL
HIKMAANDA 20945720202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM CAPSULE ORAL Rx AB
500MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Rx	AB
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Rx	AB
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Rx	AB
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Rx	AB
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Rx	AB
1GM	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB
500MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	CAPSULE	ORAL	Rx	AB
500MG	CAPSULE	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9700537	May 31, 2027	in 10 mo	U-2707
9198892	Sep 25, 2027	in 1 yr 2 mo	U-2706
8524698	Feb 09, 2030	in 3 yr 7 mo	U-1287
8546372	Feb 09, 2030	in 3 yr 7 mo	U-1287
8680144	Feb 09, 2030	in 3 yr 7 mo	U-2695
8426399	Feb 09, 2030	in 3 yr 7 mo	U-1287
12171738	Feb 09, 2030	in 3 yr 7 mo	U-4105
8415335	Feb 09, 2030	in 3 yr 7 mo	U-1287
8518929	Feb 09, 2030	in 3 yr 7 mo	U-1287
8399446	Feb 09, 2030	in 3 yr 7 mo	U-1287
8501225	Apr 29, 2030	in 3 yr 9 mo	U-1287
8617593	Apr 29, 2030	in 3 yr 9 mo	U-1478
8617594	Apr 29, 2030	in 3 yr 9 mo	U-1287
8445003	Apr 29, 2030	in 3 yr 9 mo	U-1287
8454994	Apr 29, 2030	in 3 yr 9 mo	U-2689
8618166	Apr 29, 2030	in 3 yr 9 mo	U-2689
8623406	Apr 29, 2030	in 3 yr 9 mo	U-2692
8642077	Apr 29, 2030	in 3 yr 9 mo	U-2693
8703185	Apr 29, 2030	in 3 yr 9 mo	U-2691
8691871	Apr 29, 2030	in 3 yr 9 mo	U-2689
8709475	Apr 29, 2030	in 3 yr 9 mo	U-2689
10010517	Apr 29, 2030	in 3 yr 9 mo	U-2690
10265287	Apr 29, 2030	in 3 yr 9 mo	U-2700
8563608	Apr 29, 2030	in 3 yr 9 mo	U-1287
11154526	Apr 29, 2030	in 3 yr 9 mo	U-3240
11717504	Apr 29, 2030	in 3 yr 9 mo	U-3669
10792267	Apr 29, 2030	in 3 yr 9 mo	U-2961
10842766	Apr 29, 2030	in 3 yr 9 mo	U-2997
10881632	Apr 29, 2030	in 3 yr 9 mo	U-3052
11103477	Apr 29, 2030	in 3 yr 9 mo	U-3209
8445013	Apr 29, 2030	in 3 yr 9 mo	U-1287
11213504	Apr 29, 2030	in 3 yr 9 mo	U-3292
8298554	Apr 29, 2030	in 3 yr 9 mo	Product
8410086	Jun 15, 2030	in 3 yr 11 mo	U-2688
8455472	Jun 15, 2030	in 3 yr 11 mo	U-2690
8669245	Jun 15, 2030	in 3 yr 11 mo	U-2694
8710041	Jun 15, 2030	in 3 yr 11 mo	U-2690
10842768	Jun 15, 2030	in 3 yr 11 mo	U-2688
9603826	Jun 28, 2033	in 7 yr	U-2696
9610272	Jun 28, 2033	in 7 yr	U-2697
9623001	Jun 28, 2033	in 7 yr	U-2698
9693984	Jun 28, 2033	in 7 yr	U-2697
9693985	Jun 28, 2033	in 7 yr	U-2696
9693986	Jun 28, 2033	in 7 yr	U-2698
9918954	Jun 28, 2033	in 7 yr	U-2699
10278935	Jun 28, 2033	in 7 yr	U-2701
10278937	Jun 28, 2033	in 7 yr	U-2703
10278936	Jun 28, 2033	in 7 yr	U-2702
10383840	Jun 28, 2033	in 7 yr	U-2704
10555925	Jun 28, 2033	in 7 yr	U-2744
10555924	Jun 28, 2033	in 7 yr	U-2743
11369582	Jun 28, 2033	in 7 yr	U-2841
11298333	Jun 28, 2033	in 7 yr	U-3358
10568861	Jun 28, 2033	in 7 yr	U-2756
10668042	Jun 28, 2033	in 7 yr	U-2841
10576054	Jun 28, 2033	in 7 yr	U-2762
10792270	Jun 28, 2033	in 7 yr	U-2962
10786478	Jun 28, 2033	in 7 yr	U-2959
10894028	Jun 28, 2033	in 7 yr	U-3053
11000499	Jun 28, 2033	in 7 yr	U-3126
11116742	Jun 28, 2033	in 7 yr	U-3221

Approval history

FDA approval span

First approval

Jul 26, 2012

14 yr 3 mo ago

Most recent approval

Jun 24, 2026

1 mo ago

Approvals span 2012–2026 across 13 FDA applications.

Brand (NDA) 18%

Generic (ANDA) 1292%

Icosapent ethyl: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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