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.
Cystaran
cysteamine hydrochloride · CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL · Solution · Ophthalmic · Leadiant Biosciences, Inc.
NDC 54482-0035-02 · 15 mL in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 54482-0020-02) — 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ⓘ
$176.24per unit
middle half $173.74–$195.25 · 5,151 plans · Apr 1, 2026
Est. net of rebatesⓘ
$105.74–$132.18
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
94%of plans cover it
tier 5 · prior auth 70% · step therapy 0% · qty limit 30%
*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
$2,856.70
Reported to Texas DSHS · 2026 annual filing · Leadiant Biosciences
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 $8,639.81 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA200740
- TE code
- —
- Approval date
- Oct 2, 2012
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class III · TerminatedSep 24, 2020Leadiant Biosciences, Inc. — Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
- Class III · TerminatedApr 9, 2018LEADIANT BIOSCIENCES, INC — Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
- Class III · TerminatedFeb 14, 2018LEADIANT BIOSCIENCES, INC — Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Manufacturers of cysteamine hydrochloride (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Leadiant Biosciences, Inc. | CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Recordati Rare Diseases, Inc. | CYSTEAMINE HYDROCHLORIDE 3.5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Cystaran — NDC 54482-0035-02," retrieved September 3, 2026, https://drugdashboards.com/drug/54482003502.
Free to cite with attribution — see how the data is put together.