Case	Court	Filed	Status	Judge
Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc., et al. 1:2020cv01630 3 patentsANDA 209457icosapent ethyl (ethyl icosapentate, ethyl eicosapentaenoate)	D. Del.	2020-11-30	Terminated 2022-08-30	—
Amarin Pharma, Inc. et al v. Dr. Reddy's Laboratories, Inc. et al 2:2018cv01596 12 patentsANDA 209499icosapent ethyl	NVD	2018-08-24	Terminated 2020-05-04	—
Amarin Pharma, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al 2:2017cv02641 Icosapent Ethyl	NVD	2017-10-11	Terminated 2018-05-25	—
Amarin Pharma Inc. et al v. Hikma Pharmaceuticals USA Inc. et al 2:2016cv02525 14 patentsANDA 209457icosapent ethyl	NVD	2016-10-31	Terminated 2020-03-30	—
AMARIN PHARMA, INC. et al v. DR. REDDY'S LABORATORIES, INC. et al 3:2014cv02760 16 patentsANDA 205616icosapent ethyl	D.N.J.	2014-04-30	Terminated 2014-10-02	—
Amarin Pharma, Inc. et al v. Roxane Laboratories, Inc. 1:2014cv00901 16 patentsANDA 206264Icosapent ethyl	OHND	2014-04-25	Terminated 2014-05-08	—
Amarin Pharma, Inc. et al v. Apotex, Inc. et al 1:2014cv02958 16 patentsANDA 205753icosapent ethyl	N.D. Ill.	2014-04-24	Terminated 2014-08-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

30 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Medical Research Collaborative, LLC FDA-2019-P-3424 Medical Research Collaborative, LLC filed this citizen petition on July 16, 2019, requesting that the FDA delay approval of the supplemental New Drug Application (sNDA) for icosapent ethyl (Vascepa) until drug-drug interaction studies demonstrate that mineral oil in the placebo does not attenuate th	505(q) Stay Request	2019-07-17	Denied	Medical Research Collaborative, LLC
Citizen Petition from Medical Research Collaborative LLC FDA-2019-P-3265 Medical Research Collaborative, LLC filed this citizen petition on July 8, 2019, requesting that the FDA Commissioner remove Amarin Corp.'s U.S. Patent No. 8,188,146 from the Orange Book because the patent does not claim an approved method of using icosapent ethyl (Vascepa) for its FDA-approved indi	505(q)	2019-07-09	Open	Medical Research Collaborative LLC
Citizen Petition from Medical Research Collaborative, LLC FDA-2019-P-3156 Medical Research Collaborative, LLC filed this citizen petition under 21 C.F.R. § 10.30 and 10.31 requesting that the FDA Commissioner delay approval of the supplemental New Drug Application for icosapent ethyl (Vascepa) until drug-drug interaction studies demonstrate that mineral oil in the REDUCE-	505(q) Stay Request	2019-07-01	Withdrawn	Medical Research Collaborative, LLC
Citizen Petition from Amarin Pharma Inc. FDA-2014-P-0878 Amarin Pharma Inc. filed this citizen petition on June 24, 2014, requesting that the FDA impose specific bioequivalence testing requirements on any abbreviated new drug application (ANDA) listing Vascepa (icosapent ethyl) as the referenced listed drug, including requirements that generic products co	505(q)	2014-08-26	Denied	Amarin Pharma Inc.
Citizen Petition from Gary J. Kreider FDA-2013-P-1612 Gary J. Kreider, on behalf of The EPA Drug Initiative, filed this citizen petition on December 14, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (ultra-pure eicosapentaenoic acid) and delay the PDUFA date for the ANCHOR sNDA (sNDA 2	505(q) Stay Request	2014-02-04	Denied	Gary J. Kreider
Citizen Petition from Noble Glasses FDA-2013-P-1612 The EPA Drug Initiative, an organization representing more than 1,200 supporters nationwide committed to improving cardiac health, filed this citizen petition on December 15, 2013, requesting that the FDA Commissioner overturn the decision to rescind the Special Protocol Assessment for Vascepa (icos	505(q)	2014-02-04	Denied	Noble Glasses
Citizen Petition from Richard Stricker FDA-2013-P-1612 Richard Stricker, on behalf of the EPA Drug Initiative, filed this citizen petition on December 14, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (icosapentaenoic acid) in the ANCHOR trial and delay the PDUFA date for the ANCHOR sND	505(q)	2014-02-04	Denied	Richard Stricker
Citizen Petition from Ralph Yung FDA-2013-P-1612 Ralph Yung, on behalf of EPA Drug Initiative, filed this citizen petition on December 1, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (icosapentaenoic acid) in the ANCHOR supplemental NDA (sNDA 202057/S-005) and delay the PDUFA dat	505(q) Stay Request	2014-02-04	Denied	Ralph Yung
Citizen Petition from Julie Jackle FDA-2013-P-1612 The EPA Drug Initiative, filed this citizen petition on December 3, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for VASCEPA and delay the PDUFA date for the ANCHOR sNDA (sNDA 202057/S-005), arguing that the FDA's reviewing division improperly	505(q) Stay Request	2014-02-04	Denied	Julie Jackle
Citizen Petition from Erik Sacher FDA-2013-P-1612 Erik Sacher filed a citizen petition requesting that the FDA overturn its decision to rescind the Special Protocol Assessment for VASCEPA and delay the PDUFA date for the ANCHOR sNDA (sNDA 20257/S-005). The petition was received on December 18, 2013, assigned docket number FDA-2013-P-1612/CP1, and f	Other	2014-02-04	Denied	Erik Sacher
Citizen Petition from Robert Buchan FDA-2013-P-1612 The EPA Drug Initiative, filed this citizen petition on December 15, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for VASCEPA's ANCHOR trial (sNDA 202057/S-005) and delay the PDUFA date by 180 days, arguing that the FDA's reviewing division im	Other	2014-02-04	Denied	Robert Buchan
Citizen Petition from McQuarrie Law Office FDA-2013-P-1612 Claude M. McQuarrie III of McQuarrie Law Office, on behalf of The EPA Drug Initiative, filed this citizen petition requesting that the FDA Commissioner overturn the decision to rescind the Special Protocol Assessment for VASCEPA's ANCHOR sNDA (sNDA 202057/S-005) and delay the PDUFA date by 180 days,	505(q) Stay Request	2014-02-04	Denied	McQuarrie Law Office
Citizen Petition from Lee Robertson FDA-2013-P-1612 Lee Robertson, on behalf of The EPA Drug Initiative, filed this citizen petition on December 3, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for VASCEPA (ultra-pure eicosapentaenoic acid) and delay the PDUFA date for the ANCHOR supplemental ND	505(q) Stay Request	2013-12-17	Denied	Lee Robertson
Acknowledgement Letter from FDA/DDM to Lee Robertson FDA-2013-P-1612 Lee Robertson filed a petition requesting the FDA overturn its decision to rescind the Special Protocol Assessment for VASCEPA and delay the PDUFA date for the ANCHOR supplemental NDA (sNDA 20257/S-005), which was received and assigned docket number FDA-2013-P-1612/CP5 on December 13, 2013.	505(q) Stay Request	2013-12-17	Denied	—
Citizen Petition from Edith Hoechst FDA-2013-P-1612 EPA Drug Initiative filed this citizen petition on December 3, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for VASCEPA and delay the PDUFA date for the ANCHOR supplemental NDA (sNDA 202057/S-005) for 180 days. The petitioner argues that the F	505(q)	2013-12-17	Denied	Edith Hoechst
Citizen Petition from Michael L. Everts FDA-2013-P-1612 Michael L. Everts, representing The EPA Drug Initiative, submitted this citizen petition on December 6, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (icosapentaenoic acid) and delay the PDUFA date for the ANCHOR sNDA (202057/S-005)	505(q) Stay Request	2013-12-17	Denied	Michael L. Everts
Citizen Petition from Philip Remig USI Insurance Services re EPA Drug Initia... FDA-2013-P-1612 Philip Remig, filing on behalf of the EPA Drug Initiative, submitted this citizen petition under 21 CFR 5.10 requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (icosapentaenoic acid) in the ANCHOR trial (sNDA 202057/S-005) and delay the PDUFA	505(q) Stay Request	2013-12-17	Denied	Philip Remig USI Insurance Services re EPA Drug Initiative
Citizen Petition from Thomas Ma, M. D., Ph. D. FDA-2013-P-1612 Thomas Ma, M.D., Ph.D., on behalf of EPA Drug Initiative, filed this citizen petition on December 1, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for VASCEPA (icosapentaenoic acid) and delay the PDUFA date for the ANCHOR sNDA (sNDA 202057/S-00	505(q) Stay Request	2013-12-17	Denied	Thomas Ma, M. D., Ph. D.
Citizen Petition from Lisa Hoechst FDA-2013-P-1612 Lisa Hoechst, filing on behalf of EPA Drug Initiative, submitted this citizen petition on December 3, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (ultra-pure eicosapentaenoic acid) and delay the PDUFA date for the ANCHOR sNDA (sND	505(q) Stay Request	2013-12-17	Denied	Lisa Hoechst
Citizen Petition from Bruce G. Holland FDA-2013-P-1612 EPA Drug Initiative, an organization of citizens committed to improving cardiac health, filed this citizen petition on December 2, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (icosapentaenoic acid) for the ANCHOR sNDA (202057/S-00	505(q) Stay Request	2013-12-17	Denied	Bruce G. Holland
Citizen Petition from Tom Hitchcock, R. D. FDA-2013-P-1612 Tom Hitchcock, R.D., on behalf of The EPA Drug Initiative, filed this citizen petition on December 10, 2013, requesting that the FDA Commissioner overturn the decision to rescind the Special Protocol Assessment for Vascepa (icosapentaenoic acid) and delay the PDUFA date for the ANCHOR supplemental N	505(q)	2013-12-16	Denied	Tom Hitchcock, R. D.
Citizen Petition from William Jenkins, M. D., J. D., M. B. A. FDA-2013-P-1612 William Jenkins, M.D., J.D., M.B.A., filing on behalf of EPA Drug Initiative, submitted this petition on December 1, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for VASCEPA (icosapentaenoic acid) and delay the PDUFA date for the ANCHOR supple	505(q) Stay Request	2013-12-16	Denied	William Jenkins, M. D., J. D., M. B. A.
Citizen Petition from David B. Shirley, D. V. M. FDA-2013-P-1612 David B. Shirley, D.V.M., filed this citizen petition on December 3, 2013, requesting the Commissioner overturn the FDA's decision to rescind the Special Protocol Assessment for VASCEPA (ultra-pure eicosapentaenoic acid) and delay the PDUFA date for the ANCHOR supplemental NDA (sNDA 202057/S-005), a	505(q)	2013-12-16	Denied	David B. Shirley, D. V. M.
Citizen Petition from Robert J. Blumenthal, D. M. D. FDA-2013-P-1612 Robert J. Blumenthal, D.M.D., on behalf of EPA Drug Initiative, filed this citizen petition in December 2013 requesting that the FDA Commissioner overturn the decision to rescind the Special Protocol Assessment for VASCEPA (icosapentaenoic acid) and delay the PDUFA date for the ANCHOR supplemental N	505(q) Stay Request	2013-12-16	Denied	Robert J. Blumenthal, D. M. D.
Citizen Petition from Carl D. Overton FDA-2013-P-1612 EPA Drug Initiative filed this citizen petition on December 1, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for the ANCHOR trial of Vascepa (icosapentaenoic acid) for mixed dyslipidemia patients with elevated triglyceride levels, and delay the	505(q) Stay Request	2013-12-16	Denied	Carl D. Overton
Citizen Petition from Allen Seto FDA-2013-P-1612 EPA Drug Initiative submitted this citizen petition on December 3, 2013, requesting that the FDA Commissioner overturn the agency's decision to rescind the Special Protocol Assessment for the ANCHOR trial of Vascepa (icosapentaenoic acid) and delay the PDUFA date for the ANCHOR sNDA 202057/S-005, ar	505(q) Stay Request	2013-12-16	Denied	Allen Seto
Citizen Petition from Joseph Vafi FDA-2013-P-1612 Joseph Vafi on behalf of EPA Drug Initiative, an organization representing over 1,200 supporters, filed this citizen petition on December 2, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa's ANCHOR trial and delay the PDUFA date for A	505(q) Stay Request	2013-12-16	Denied	Joseph Vafi
Citizen Petition from Gary Head and Partners Painting Corporation FDA-2013-P-1612 EPA Drug Initiative, an organization representing more than 1,200 supporters nationwide, filed this citizen petition on December 1, 2013, requesting that the FDA Commissioner overturn the agency's decision to rescind the Special Protocol Assessment for VASCEPA (ultra-pure eicosapentaenoic acid) and	505(q) Stay Request	2013-12-16	Denied	Gary Head and Partners Painting Corporation
Citizen Petition from Lee Wilson FDA-2013-P-1612 Lee Wilson, filing on behalf of EPA Drug Initiative, a citizen organization representing over 1,200 supporters, submitted this petition on December 1, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for VASCEPA (icosapentaenoic acid) in the ANCHO	505(q)	2013-12-16	Denied	Lee Wilson
Citizen Petition from Interaction Design, Inc. FDA-2013-P-1612 Interaction Design, Inc., filing on behalf of The EPA Drug Initiative, submitted this citizen petition on December 4, 2013, requesting that the FDA Commissioner overturn the rescission of the Special Protocol Assessment for Vascepa (ultra-pure eicosapentaenoic acid) and delay the PDUFA date for the	505(q) Stay Request	2013-12-13	Denied	Interaction Design, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
EPA for Metastasis Trial 2 NCT03428477	Phase 3	Active	Mark A Hull, PhD FRCP	418	2018-05-02 → 2026-04-30
A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia NCT07680829	Phase 3	Not Yet Recruiting	Zhejiang Doer Biologics Co., Ltd.	378	2026-08 → 2030-10
Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CT NCT07762755	Phase 4	Not Yet Recruiting	China National Center for Cardiovascular Diseases	100	2026-08-01 → 2029-12-31
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia NCT04177680	Phase 2	Completed	Matinas BioPharma Nanotechnologies, Inc.	100	2020-06-03 → 2021-01-18
The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism NCT04152291	N/A	Completed	Wihuri Research Institute	68	2019-11-12 → 2024-12-31
Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid NCT02719327	Phase 2/3	Completed	VA Office of Research and Development	131	2017-06-08 → 2023-09-29
Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy NCT02926027	Phase 4	Completed	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	80	2017-03-28 → 2020-08-15
Vascepa to Accelerate Lipoprotein Uptake and Elimination NCT03885661	Phase 1	Completed	University of Pennsylvania	20	2016-01-11 → 2021-06
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects NCT02422446	Phase 3	Terminated	Brigham and Women's Hospital	2	2015-04 → 2017-03-01
Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer NCT02940223	Phase 2	Terminated	M.D. Anderson Cancer Center	2	2017-03-16 → 2020-11-24

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$251.74

Highest Price

$384.67

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52937-0001-20VASCEPA 1GM CAP	$251.74	Big4	Amarin Pharma, Inc.	08/31/2029
52937-0001-20VASCEPA 1GM CAP	$328.78	FSS	Amarin Pharma, Inc.	08/31/2029
52937-0003-40VASCEPA 500MG CAP	$293.68	Big4	Amarin Pharma, Inc.	08/31/2029
52937-0003-40VASCEPA 500MG CAP	$384.67	FSS	Amarin Pharma, Inc.	08/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Vascepa (2024)

Total Spending

$724.2M

Total Claims

1,474,990

Beneficiaries

301,070

Avg Cost/Unit

$2.87

Spending Trend

$489.4M(2019)→$754.8M(2020)→$832.0M(2021)→$787.9M(2022)→$764.0M(2023)→$724.2M(2024)

YoY Change:-8.3%

5yr CAGR:+0.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

FINORGA SASICOSAPENT ETHYL

DMF 271822013

HUATAI PHARMA INCICOSAPENT ETHYL

DMF 349592020

SICHUAN GOWELL PHARMACEUTICAL CO LTDICOSAPENT ETHYL

DMF 358542021

AK BIOPHARM CO LTDICOSAPENT ETHYL

DMF 368222022

KINOMEGA BIOPHARM INCICOSAPENT ETHYL

DMF 390402023

SKUNY BIOSCIENCE CO LTDInactiveICOSAPENT ETHYL

DMF 284222014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Aug 17, 2026	SUPPL -58	View Letter (PDF)
Dec 17, 2019	SUPPL -35	View Letter (PDF)
Feb 14, 2014	SUPPL -6	View Letter (PDF)
Nov 27, 2013	SUPPL -9	View Letter (PDF)
Feb 4, 2013	SUPPL -1	View Letter (PDF)
Jul 30, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM

RLDAB

63 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 26, 2012

Patents (63)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8298554	Apr 29, 2030	—	—	Yes	—	—
8410086	Jun 15, 2030	—	—	—		—
8415335	Feb 9, 2030	—	—	—		—
8426399	Feb 9, 2030	—	—	—		—
8445003	Apr 29, 2030	—	—	—		—
8445013	Apr 29, 2030	—	—	—		—
8454994	Apr 29, 2030	—	—	—		—
8455472	Jun 15, 2030	—	—	—		—
8501225	Apr 29, 2030	—	—	—		—
8518929	Feb 9, 2030	—	—	—		—
8524698	Feb 9, 2030	—	—	—		—
8546372	Feb 9, 2030	—	—	—		—
8563608	Apr 29, 2030	—	—	—		—
8617593	Apr 29, 2030	—	—	—		—
8617593	Apr 29, 2030	—	—	—		—
8617594	Apr 29, 2030	—	—	—		—
8618166	Apr 29, 2030	—	—	—		—
8623406	Apr 29, 2030	—	—	—		—
8623406	Apr 29, 2030	—	—	—		—
8642077	Apr 29, 2030	—	—	—		—
8669245	Jun 15, 2030	—	—	—		—
8680144	Feb 9, 2030	—	—	—		—
8691871	Apr 29, 2030	—	—	—		—
8703185	Apr 29, 2030	—	—	—		—
8709475	Apr 29, 2030	—	—	—		—
8710041	Jun 15, 2030	—	—	—		—
9198892	Sep 25, 2027	—	—	—		—
9603826	Jun 28, 2033	—	—	—		—
9610272	Jun 28, 2033	—	—	—		—
9623001	Jun 28, 2033	—	—	—		—
9693984	Jun 28, 2033	—	—	—		—
9693985	Jun 28, 2033	—	—	—		—
9693986	Jun 28, 2033	—	—	—		—
9700537	May 31, 2027	—	—	—		—
9918954	Jun 28, 2033	—	—	—		—
10010517	Apr 29, 2030	—	—	—		—
10265287	Apr 29, 2030	—	—	—		—
10278935	Jun 28, 2033	—	—	—		—
10278936	Jun 28, 2033	—	—	—		—
10278937	Jun 28, 2033	—	—	—		—
10383840	Jun 28, 2033	—	—	—		—
10555924	Jun 28, 2033	—	—	—		—
10555925	Jun 28, 2033	—	—	—		—
10568861	Jun 28, 2033	—	—	—		—
10576054	Jun 28, 2033	—	—	—		—
10668042	Jun 28, 2033	—	—	—		—
10786478	Jun 28, 2033	—	—	—		—
10786478	Jun 28, 2033	—	—	—		—
10792267	Apr 29, 2030	—	—	—		—
10792270	Jun 28, 2033	—	—	—		—
10842766	Apr 29, 2030	—	—	—		—
10842768	Jun 15, 2030	—	—	—		—
10881632	Apr 29, 2030	—	—	—		—
10894028	Jun 28, 2033	—	—	—		—
11000499	Jun 28, 2033	—	—	—		—
11103477	Apr 29, 2030	—	—	—		—
11116742	Jun 28, 2033	—	—	—		—
11154526	Apr 29, 2030	—	—	—		—
11213504	Apr 29, 2030	—	—	—		—
11298333	Jun 28, 2033	—	—	—		—
11369582	Jun 28, 2033	—	—	—		—
11717504	Apr 29, 2030	—	—	—		—
12171738	Feb 9, 2030	—	—	—		—

#002 — 500MG

RLDAB

62 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 16, 2017