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.
Ohtuvayre
ensifentrine · ENSIFENTRINE 3 mg/2.5mL · Suspension · Respiratory (Inhalation) · Merck Sharp & Dohme Llc
NDC 83034-0003-65 · 60 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 83034-0003-60) — 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ⓘ
$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.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Hovione Farmaciencia, S.a.Portugalanalysis · api manufacture
- analysis
- Quality Chemical LaboratoriesUnited Statesanalysis
- The Ritedose CorporationUnited Stateslabel · pack
- The Ritedose CorporationUnited Statesanalysis · label · manufacture · pack
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 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- 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
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | Jun 26, 2029 |
| patent | 12251384 | Jun 25, 2044 |
| patent | 12409180 | Feb 20, 2043 |
| patent | 9956171 | Sep 15, 2035 |
| patent | 10945950 | Sep 15, 2035 |
| patent | 9062047 | Aug 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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Merck Sharp & Dohme Llc | ENSIFENTRINE 3 mg/2.5mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Ohtuvayre — NDC 83034-0003-65," retrieved September 3, 2026, https://drugdashboards.com/drug/83034000365.
Free to cite with attribution — see how the data is put together.