DrugDashboards

Ohtuvayre

ensifentrine · ENSIFENTRINE 3 mg/2.5mL · Suspension · Respiratory (Inhalation) · Merck Sharp & Dohme Llc

NDC 83034-0003-60 · 60 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

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.

  • Medicare Part B pays (ASP+6%)$52.12per billing unit (3 MG)HCPCS J7601 · Jul 1, 2026
  • Part D plans paid (avg)$18.91per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$18.72per unitnegotiated price across 448 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$2,253.27per package of 60X2.5MLVerona Pharma, Inc. · Jan 1, 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
$18.72per unit
middle half $18.72$19.50 · 448 plans · Apr 1, 2026
Est. net of rebates
$11.23–$14.04
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
8%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 58%

*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 7 quarters since 2024.

NADAC price per unit

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

Estimated fill cost

WAC per package, as filed
$19.67
Reported to Texas DSHS · 2026 annual filing · Verona Pharma, Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 3 MG
$52.117
HCPCS J7601 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$30.2M
18,143 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $2,836.06 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA217389
TE code
Approval date
Jun 26, 2024
Patents / exclusivity
5 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityNCEJun 26, 2029
patent12251384Jun 25, 2044
patent12409180Feb 20, 2043
patent9956171Sep 15, 2035
patent10945950Sep 15, 2035
patent9062047Aug 21, 2031

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of ensifentrine (Suspension)

LabelerStrengthFirst seenLast seen
Merck Sharp & Dohme LlcENSIFENTRINE 3 mg/2.5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Ohtuvayre — NDC 83034-0003-60," retrieved September 3, 2026, https://drugdashboards.com/drug/83034000360.

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