DrugDashboards

icosapent ethyl

icosapent ethyl · ICOSAPENT ETHYL 1 g/1 · Capsule · Oral · Softgel Healthcare Private Limited

NDC 35916-1592-01 · 120 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

21 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00054-0508-23) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$1.13per unit
middle half $0.8702$1.48 · 1,887 plans · Apr 1, 2026
Est. net of rebates
≈ $1.13
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
34%of plans cover it
tier 4 · prior auth 1% · step therapy 0% · qty limit 29%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for icosapent ethyl (oral solid) in the next 90 days

sole-source market · 1 Class I/II recall(s) in 12 months

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Regulatory

Application
ANDA217656
TE code
AB
Approval date
Apr 20, 2023
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Icosapent Ethyl, Capsule, 1 g (NDC 60429-005-12)Apr 1, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of icosapent ethyl (Capsule)

LabelerStrengthFirst seenLast seen
Amarin Pharma Inc.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 3, 2026
Catalent Pharma Solutions, LLCICOSAPENT 500 mg/1Jul 15, 2026Sep 3, 2026
Northstar Rx LLCICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 3, 2026
Patheon Softgels Inc.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 3, 2026
Patheon Softgels Inc.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 3, 2026
Amarin Pharma Inc.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Apotex CorpICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCICOSAPENT 1000 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories, Inc.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories, Inc.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
NextPharma PloermelICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Patheon Softgels B.V.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 2, 2026
Patheon Softgels B.V.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Softgel Healthcare Private LimitedICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Softgel Healthcare Private LimitedICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Vitruvias Therapeutics, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Patheon Softgels, Inc.ICOSAPENT ETHYL 998 mg/1Jul 15, 2026Aug 19, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "icosapent ethyl — NDC 35916-1592-01," retrieved September 3, 2026, https://drugdashboards.com/drug/35916159201.

Free to cite with attribution — see how the data is put together.