DrugDashboards

Harvoni

LEDIPASVIR and SOFOSBUVIR · LEDIPASVIR 90 mg/1; SOFOSBUVIR 400 mg/1 · Tablet, Film Coated · Oral · Gilead Sciences, Inc

NDC 61958-1801-01 · 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price has held steady around $1098.94 per unit over the past year.

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)$1,073.72per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$1,070.54per unitnegotiated price across 860 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$800.45per unitGilead Sciences, Inc. · Jan 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
$1,070.54per unit
middle half $1,060.14$1,087.94 · 860 plans · Apr 1, 2026
Est. net of rebates
$642.32–$802.90
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
16%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 80%

*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$500.00$1000.00$1500.00Jan 2015Mar 2018$1098.94
8 price points · per · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$31,500.00
Reported to Texas DSHS · 2026 annual filing · Gilead Sciences, Inc.

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

Medicaid spend (2024)

$787,804
24 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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $30,615.34 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA205834
TE code
Approval date
Oct 10, 2014
Patents / exclusivity
66 patents, 2 exclusivities
TypeNumber / codeExpires
exclusivityODE*Aug 28, 2026
exclusivityODE*Aug 28, 2026
patent10039779*PEDJul 30, 2034
patent10039779*PEDJul 30, 2034
patent10039779Jan 30, 2034
patent10039779Jan 30, 2034
patent9393256*PEDMar 14, 2033
patent9393256*PEDMar 14, 2033
patent10456414Sep 14, 2032
patent9393256Sep 14, 2032
patent9393256Sep 14, 2032
patent10456414Sep 14, 2032

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of LEDIPASVIR and SOFOSBUVIR (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Asegua Therapeutics LLCLEDIPASVIR 90 mg/1; SOFOSBUVIR 400 mg/1Jul 15, 2026Sep 2, 2026
Gilead Sciences, IncLEDIPASVIR 45 mg/1; SOFOSBUVIR 200 mg/1Jul 15, 2026Sep 2, 2026
Gilead Sciences, IncLEDIPASVIR 90 mg/1; SOFOSBUVIR 400 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Harvoni — NDC 61958-1801-01," retrieved September 3, 2026, https://drugdashboards.com/drug/61958180101.

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