The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
iwilfin
Eflornithine Hydrochloride · EFLORNITHINE HYDROCHLORIDE 250 mg/1 · Tablet · Oral · Uswm, Llc
NDC 78670-0150-01 · 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE · NDA · View full market →
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ⓘ
$103.05per unit
middle half $101.96–$105.98 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$61.83–$77.29
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · qty limit 91%
*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 9 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
$10,160.00
Reported to Texas DSHS · 2026 annual filing · Uswm, Llc
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$7.3M
496 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Aphena Pharma Solutions - Tennessee, LLCUnited Stateslabel · pack
- Corerx, Inc.United Statesmanufacture
- Corerx, Inc.United Statesanalysis · manufacture
- Quality Chemical LaboratoriesUnited Statesanalysis
- ScinoPharm Taiwan, Ltd.Taiwananalysis · api manufacture · pack
- SGS North America Inc.United Statesanalysis
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA215500
- TE code
- —
- Approval date
- Dec 13, 2023
- Patents / exclusivity
- 1 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-462 | Dec 13, 2030 |
| exclusivity | NP | Dec 13, 2026 |
| patent | 12582625 | Feb 12, 2036 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Eflornithine Hydrochloride (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| CoreRx, Inc. | EFLORNITHINE HYDROCHLORIDE 250 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Uswm, Llc | EFLORNITHINE HYDROCHLORIDE 250 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, "iwilfin — NDC 78670-0150-01," retrieved September 3, 2026, https://drugdashboards.com/drug/78670015001.
Free to cite with attribution — see how the data is put together.