DrugDashboards

icosapent ethyl

icosapent ethyl · ICOSAPENT ETHYL 1 g/1 · Capsule · Oral · Zydus Pharmaceuticals USA Inc.

NDC 70710-1592-07 · 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 price is down 24% over the past year, to $0.4414 per unit. A Class II recall hit this product in the past year (Zydus Pharmaceuticals (USA) Inc). Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Pharmacies pay (NADAC)$0.4414per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$1.44per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.4623per CAPweighted avg manufacturer price $0.2642 · Jul 1, 2026105% of what pharmacies pay — higher than 62% of drugs with this benchmark

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

$0$0.5$1.00Jun 2024Sep 2026$0.4414
28 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$13.24
#90 count
$39.72

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$8,968
87 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

23Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • Class I/II recall in past 12 months+15
  • price down 20% year over year+8

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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)

  • Class II · OngoingMar 9, 2026
    Zydus Pharmaceuticals (USA) IncFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
  • Class II · OngoingMay 30, 2025
    Zydus Pharmaceuticals (USA) IncFailed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

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 70710-1592-07," retrieved September 3, 2026, https://drugdashboards.com/drug/70710159207.

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