DrugDashboards

Fabhalta

iptacopan · IPTACOPAN HYDROCHLORIDE 200 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation

NDC 00078-1189-20 · 60 CAPSULE in 1 BOTTLE · NDA · View full market →

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.

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.

  • Part D plans paid (avg)$749.18per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$795.36per unitnegotiated price across 299 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ 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
$795.36per unit
middle half $760.80$803.33 · 299 plans · Apr 1, 2026
Est. net of rebates
$477.21–$596.52
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
5%of plans cover it
tier 5 · prior auth 67% · step therapy 0% · qty limit 59%

*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
$46,561.64
Reported to Texas DSHS · 2026 annual filing · Novartis Pharmaceuticals Corporation

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$18.1M
402 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

Is this a "specialty" drug?

There's no legal definition — it meets 4 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $44,917.40 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Fabhalta

Regulatory

Application
NDA218276
TE code
Approval date
Dec 5, 2023
Patents / exclusivity
8 patents, 5 exclusivities
TypeNumber / codeExpires
exclusivityODE-524Mar 20, 2032
exclusivityODE-456Dec 5, 2030
exclusivityNCEDec 5, 2028
exclusivityI-963Mar 20, 2028
exclusivityI-949Aug 7, 2027
patent12453726Jul 15, 2041
patent11951101Jul 15, 2041
patent11603363May 25, 2041
patent12384758May 17, 2041
patent12285422Aug 30, 2038
patent11723901Aug 30, 2038
patent9682968Jul 14, 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 iptacopan (Capsule)

LabelerStrengthFirst seenLast seen
Novartis Pharma Produktions GmbHIPTACOPAN HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationIPTACOPAN HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Fabhalta — NDC 00078-1189-20," retrieved September 3, 2026, https://drugdashboards.com/drug/00078118920.

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