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.
Oxlumo
lumasiran · LUMASIRAN SODIUM 94.5 mg/.5mL · Injection, Solution · Subcutaneous · Alnylam Pharmaceuticals, Inc.
NDC 71336-1002-01 · 1 VIAL, SINGLE-USE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-USE · NDA · View full market →
One drug, every price
The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.
ⓘ How this was built
Data sources
- CMS NADAC (pharmacy acquisition, weekly)
- CMS Part B ASP quarterly payment limits
- CMS Maximum Fair Prices (IRA negotiated, NDC-level)
- Medicare Part D Spending by Drug (data.cms.gov, name-matched)
- VA FSS / Big4 federal contract prices (va.gov, twice monthly)
- ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
- California SB-17 WAC filings (list price, per package)
Method
Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
- Medicare Part B pays (ASP+6%)$336.97per billing unit (0.5 MG)HCPCS J0224 · Jul 1, 2026
- Part D plans paid (avg)$117,822.65per dosage unitgross, before rebates — matched by drug name · 2024
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
$60,099.00
Reported to Texas DSHS · 2026 annual filing · Alnylam Pharmaceuticals
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 0.5 MG
$336.974
HCPCS J0224 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- PCI San Diego, Inc.United Statesmanufacture
- analysis · manufacture
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 3 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $151,486.26 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA214103
- TE code
- —
- Approval date
- Nov 23, 2020
- Patents / exclusivity
- 14 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-415 | Oct 6, 2029 |
| exclusivity | ODE-339 | Nov 23, 2027 |
| patent | 11261447 | Nov 20, 2038 |
| patent | 10478500 | Oct 9, 2035 |
| patent | 11446380 | Oct 9, 2035 |
| patent | 11401517 | Aug 14, 2035 |
| patent | 10612024 | Aug 14, 2035 |
| patent | 10612027 | Aug 14, 2035 |
| patent | 11060093 | Dec 26, 2034 |
| patent | 10435692 | Dec 26, 2034 |
| patent | 10487330 | Dec 26, 2034 |
| patent | 9828606 | Dec 26, 2034 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of lumasiran (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Alnylam Pharmaceuticals, Inc. | LUMASIRAN SODIUM 94.5 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Oxlumo — NDC 71336-1002-01," retrieved September 3, 2026, https://drugdashboards.com/drug/71336100201.
Free to cite with attribution — see how the data is put together.