DrugDashboards

Givlaari

givosiran sodium · GIVOSIRAN SODIUM 189 mg/mL · Injection, Solution · Subcutaneous · Alnylam Pharmaceuticals, Inc.

NDC 71336-1001-01 · 1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE · NDA · View full market →

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.

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%)$120.92per billing unit (0.5 MG)HCPCS J0223 · Jul 1, 2026
  • Part D plans paid (avg)$41,591.25per 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
$43,894.00
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
$120.915
HCPCS J0223 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$9.4M
227 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

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 $61,350.15 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA212194
TE code
Approval date
Nov 20, 2019
Patents / exclusivity
8 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityODE-273Nov 20, 2026
patent10119143Oct 3, 2034
patent11028392Oct 3, 2034
patent9133461Nov 30, 2033
patent9631193Mar 15, 2033
patent10125364Mar 15, 2033
patent8106022Dec 12, 2029
patent8828956Dec 4, 2028
patent10131907Aug 24, 2028

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of givosiran sodium (Injection, Solution)

LabelerStrengthFirst seenLast seen
Alnylam Pharmaceuticals, Inc.GIVOSIRAN SODIUM 189 mg/mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Givlaari — NDC 71336-1001-01," retrieved September 3, 2026, https://drugdashboards.com/drug/71336100101.

Free to cite with attribution — see how the data is put together.