DrugDashboards

Prezista

darunavir · DARUNAVIR ETHANOLATE 150 mg/1 · Tablet, Film Coated · Oral · Janssen Products LP

NDC 59676-0564-01 · 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply.

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)$53.75per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$9.04per unitnegotiated price across 5,496 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$6.37per unitJanssen Products, LP · 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
$9.04per unit
middle half $8.85$9.38 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$5.43–$6.78
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 0% · step therapy 0% · qty limit 87%

*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
$8.99
Reported to Texas DSHS · 2026 annual filing · Johnson & Johnson Health Care Systems Inc

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

Supply fragility

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

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for darunavir (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 →

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $2,008.75 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA021976
TE code
AB
Approval date
Jun 23, 2006
Patents / exclusivity
12 patents, 0 exclusivities
TypeNumber / codeExpires
patent7700645*PEDJun 26, 2027
patent7700645*PEDJun 26, 2027
patent7700645*PEDJun 26, 2027
patent7700645*PEDJun 26, 2027
patent7700645*PEDJun 26, 2027
patent7700645*PEDJun 26, 2027
patent7700645Dec 26, 2026
patent7700645Dec 26, 2026
patent7700645Dec 26, 2026
patent7700645Dec 26, 2026
patent7700645Dec 26, 2026
patent7700645Dec 26, 2026

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of darunavir (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals NY LLCDARUNAVIR 600 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCDARUNAVIR 800 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedDARUNAVIR PROPYLENE GLYCOLATE 600 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedDARUNAVIR PROPYLENE GLYCOLATE 800 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackDARUNAVIR 800 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DARUNAVIR 400 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DARUNAVIR 800 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncDARUNAVIR 600 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncDARUNAVIR 800 mg/1Jul 15, 2026Sep 2, 2026
Janssen Products LPDARUNAVIR ETHANOLATE 150 mg/1Jul 15, 2026Sep 2, 2026
Janssen Products LPDARUNAVIR ETHANOLATE 75 mg/1Jul 15, 2026Sep 2, 2026
Janssen Products LPDARUNAVIR ETHANOLATE 600 mg/1Jul 15, 2026Sep 2, 2026
Janssen Products LPDARUNAVIR ETHANOLATE 800 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.DARUNAVIR ETHANOLATE 800 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.DARUNAVIR ETHANOLATE 600 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCDARUNAVIR 800 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCDARUNAVIR 600 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals, Inc.DARUNAVIR PROPYLENE GLYCOLATE 800 mg/1Jul 15, 2026Sep 2, 2026
Viona Pharmaceuticals IncDARUNAVIR 800 mg/1Jul 15, 2026Sep 2, 2026
Viona Pharmaceuticals IncDARUNAVIR 600 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedDARUNAVIR 800 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedDARUNAVIR 600 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DARUNAVIR 600 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Prezista — NDC 59676-0564-01," retrieved September 3, 2026, https://drugdashboards.com/drug/59676056401.

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