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.
Nulibry
fosdenopterin hydrobromide · FOSDENOPTERIN HYDROBROMIDE 9.5 mg/1 · Injection, Powder, Lyophilized, For Solution · Intravenous · Sentynl Therapeutics, Inc.
NDC 42358-0295-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE · NDA · View full market →
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%)$17.74per billing unit (0.1 MG)HCPCS J1809 · Jul 1, 2026
- Federal ceiling (Big4)$1,136.13per unitSentynl Therapeutics · Jan 1, 2026
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →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
$1,622.00
Reported to Texas DSHS · 2026 annual filing · Sentynl Therapeutics, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 0.1 MG
$17.736
HCPCS J1809 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Alcami Carolinas CorporationUnited Statesmanufacture
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
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA214018
- TE code
- —
- Approval date
- Feb 26, 2021
- Patents / exclusivity
- 1 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-342 | Feb 26, 2028 |
| exclusivity | NCE | Feb 26, 2026 |
| patent | 7504095 | Apr 9, 2029 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of fosdenopterin hydrobromide (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Sentynl Therapeutics, Inc. | FOSDENOPTERIN HYDROBROMIDE 9.5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Nulibry — NDC 42358-0295-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42358029501.
Free to cite with attribution — see how the data is put together.