The short version
6 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Nitisinone
Nitisinone · NITISINONE 10 mg/1 · Capsule · Oral · Eton Pharmaceuticals, Inc.
NDC 71863-0121-60 · 1 BOTTLE in 1 CARTON / 60 CAPSULE in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 66658-0110-60) — 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ⓘ
$267.76per unit
middle half $267.76–$267.76 · 2 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $267.76
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 0%
*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 10 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
$19,290.00
Reported to Texas DSHS · 2026 annual filing · Eton Pharmaceuticals, Inc.
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 $11,669.58 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA216201
- TE code
- AB
- Approval date
- May 25, 2023
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Nitisinone (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Analog Pharma | NITISINONE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Analog Pharma | NITISINONE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Analog Pharma | NITISINONE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Analog Pharma | NITISINONE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | NITISINONE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | NITISINONE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | NITISINONE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Eton Pharmaceuticals, Inc. | NITISINONE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Eton Pharmaceuticals, Inc. | NITISINONE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Eton Pharmaceuticals, Inc. | NITISINONE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Eton Pharmaceuticals, Inc. | NITISINONE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Swedish Orphan Biovitrum Ab (Publ) | NITISINONE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Swedish Orphan Biovitrum Ab (Publ) | NITISINONE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Swedish Orphan Biovitrum Ab (Publ) | NITISINONE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Swedish Orphan Biovitrum Ab (Publ) | NITISINONE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Par Health USA, LLC | NITISINONE 5 mg/1 | Aug 8, 2026 | Aug 29, 2026 |
| Par Health USA, LLC | NITISINONE 2 mg/1 | Aug 8, 2026 | Aug 29, 2026 |
| Par Health USA, LLC | NITISINONE 10 mg/1 | Aug 8, 2026 | Aug 29, 2026 |
| Endo USA, Inc. | NITISINONE 5 mg/1 | Jul 15, 2026 | Aug 5, 2026 |
| Endo USA, Inc. | NITISINONE 2 mg/1 | Jul 15, 2026 | Aug 5, 2026 |
| Endo USA, Inc. | NITISINONE 10 mg/1 | Jul 15, 2026 | Aug 5, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Nitisinone — NDC 71863-0121-60," retrieved September 3, 2026, https://drugdashboards.com/drug/71863012160.
Free to cite with attribution — see how the data is put together.