DrugDashboards

Ongentys

opicapone · OPICAPONE 25 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC

NDC 64896-0402-01 · 30 CAPSULE in 1 BOTTLE · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price is up 15% over the past year, to $24.67 per unit. 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)$24.67per EAinvoice-surveyed acquisition cost · Jan 5, 2026
  • Part D plans paid (avg)$21.75per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$24.13per unitnegotiated price across 368 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$16.26per unitAmneal Pharmaceuticals of New York, LLC · Jan 1, 202666% of what pharmacies pay — a deeper discount than 81% of drugs with this benchmark
  • List price (WAC, as filed)$773.55per packageAmneal Pharmaceuticals · Jan 5, 2026

Medicare Part D

All Part D pricing →
ⓘ 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
$24.13per unit
middle half $23.37$24.64 · 368 plans · Apr 1, 2026
Est. net of rebates
$14.48–$18.10
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
7%of plans cover it
tier 3 · prior auth 13% · step therapy 4% · qty limit 16%

*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 8 quarters since 2024.

NADAC price per unit

$0$10.00$20.00$30.00Aug 2024Jan 2026$24.67
14 price points · per EA · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

#30 count
$740.04
#90 count
$2220.12

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

Medicaid spend (2025)

$20,739
25 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

20Low risk

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

  • 2 active manufacturers+20

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 opicapone (oral solid) in the next 90 days

sole-source market · price up 5% YoY

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
NDA212489
TE code
Approval date
Apr 24, 2020
Patents / exclusivity
18 patents, 0 exclusivities
TypeNumber / codeExpires
patent9630955Dec 12, 2032
patent9630955Dec 12, 2032
patent12129247Jan 11, 2032
patent12129247Jan 11, 2032
patent10071085Mar 31, 2030
patent10583130Mar 31, 2030
patent10071085Mar 31, 2030
patent10583130Mar 31, 2030
patent8524746Jul 14, 2029
patent8524746Jul 14, 2029
patent9745290Oct 10, 2027
patent9745290Oct 10, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of opicapone (Capsule)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals LLCOPICAPONE 25 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCOPICAPONE 50 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCOPICAPONE 25 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCOPICAPONE 50 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Ongentys — NDC 64896-0402-01," retrieved September 3, 2026, https://drugdashboards.com/drug/64896040201.

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