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.
Vykoura
leucovorin calcium · LEUCOVORIN CALCIUM 50 mg/5mL · Injection · Intramuscular; Intravenous · Avyxa Pharma, LLC
NDC 83831-0147-05 · 1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE · NDA · View full market →
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
$125.00
Reported to Texas DSHS · 2026 annual filing · Avyxa Pharma, LLC
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
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 $46.44 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA220406
- TE code
- —
- Approval date
- Feb 3, 2026
- Patents / exclusivity
- 3 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 12564592 | Dec 23, 2044 |
| patent | 12564592 | Dec 23, 2044 |
| patent | 12564592 | Dec 23, 2044 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of leucovorin calcium (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Fresenius Kabi USA, LLC | LEUCOVORIN CALCIUM 10 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Avyxa Pharma, LLC | LEUCOVORIN CALCIUM 350 mg/35mL | Jul 15, 2026 | Sep 2, 2026 |
| Avyxa Pharma, LLC | LEUCOVORIN CALCIUM 50 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Avyxa Pharma, LLC | LEUCOVORIN CALCIUM 500 mg/50mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Vykoura — NDC 83831-0147-05," retrieved September 3, 2026, https://drugdashboards.com/drug/83831014705.
Free to cite with attribution — see how the data is put together.