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.
Brineura
cerliponase alfa · Kit · BioMarin Pharmaceutical Inc.
NDC 68135-0811-02 · 1 KIT in 1 CARTON * 5 mL in 1 VIAL, GLASS * 5 mL in 1 VIAL, GLASS · BLA · 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
$35,874.00
Reported to Texas DSHS · 2026 annual filing · BioMarin Pharmaceutical Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$2.9M
108 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- label · pack
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 1 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
- BLA761052
- TE code
- —
- Approval date
- —
- 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 cerliponase alfa (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| BioMarin Pharmaceutical Inc. | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Brineura — NDC 68135-0811-02," retrieved September 3, 2026, https://drugdashboards.com/drug/68135081102.
Free to cite with attribution — see how the data is put together.