DrugDashboards

Gilenya

Fingolimod hcl · FINGOLIMOD HYDROCHLORIDE .5 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation

NDC 00078-0607-15 · 30 CAPSULE in 1 BOTTLE · NDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price is up 21% over the past year, to $414.71 per unit. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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.

  • Pharmacies pay (NADAC)$414.71per EAinvoice-surveyed acquisition cost · Jan 7, 2026
  • Part D plans paid (avg)$337.02per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$412.70per unitnegotiated price across 17 plans — before rebates · Apr 1, 2026
  • Medicaid generic ceiling (FUL)$66.97per CAPweighted avg manufacturer price $38.2714 · Aug 1, 202616% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark
  • List price (WAC, as filed)$12,840.67per packageNovartis · Jan 7, 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
$412.70per unit
middle half $412.58$412.70 · 17 plans · Apr 1, 2026
Est. net of rebates
$247.62–$309.52
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
0%of plans cover it
tier 5 · prior auth 12% · step therapy 0% · qty limit 100%

*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

$0$200.00$400.00$600.00Mar 2015Jan 2026$414.71
30 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$12441.33
#90 count
$37323.99

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$17.9M
1,609 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

10Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for fingolimod hcl (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Is this a "specialty" drug?

There's no legal definition — it meets 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $11,833.72 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA022527
TE code
AB
Approval date
Sep 21, 2010
Patents / exclusivity
3 patents, 0 exclusivities
TypeNumber / codeExpires
patent9592208*PEDSep 30, 2032
patent9592208Mar 30, 2032
patent10543179Dec 25, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Fingolimod hcl (Capsule)

LabelerStrengthFirst seenLast seen
Novartis Pharma Stein AGFINGOLIMOD HYDROCHLORIDE .5 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationFINGOLIMOD HYDROCHLORIDE .25 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationFINGOLIMOD HYDROCHLORIDE .5 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.FINGOLIMOD HYDROCHLORIDE .5 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Gilenya — NDC 00078-0607-15," retrieved September 3, 2026, https://drugdashboards.com/drug/00078060715.

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