DrugDashboards

darunavir ethanolate and cobicistat

darunavir ethanolate and cobicistat · DARUNAVIR ETHANOLATE 800 mg/1; COBICISTAT 150 mg/1 · Tablet, Film Coated · Janssen Ortho LLC

NDC 17314-0812-00 · 6070 TABLET, FILM COATED in 1 DRUM · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 59676-0575-30) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$78.84per unit
middle half $77.93$82.17 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $78.84
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 0% · step therapy 0% · qty limit 57%

*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.

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 ethanolate and cobicistat (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 →

Regulatory

Application
TE code
Approval date
Patents / exclusivity

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 ethanolate and cobicistat (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Janssen Ortho LLCDARUNAVIR ETHANOLATE 800 mg/1; COBICISTAT 150 mg/1Aug 20, 2026Sep 3, 2026
A-S Medication SolutionsDARUNAVIR ETHANOLATE 800 mg/1; COBICISTAT 150 mg/1Aug 26, 2026Sep 2, 2026
Janssen Products, LPDARUNAVIR ETHANOLATE 800 mg/1; COBICISTAT 150 mg/1Aug 26, 2026Sep 2, 2026
Janssen Products, LPDARUNAVIR ETHANOLATE 675 mg/1; COBICISTAT 150 mg/1Aug 26, 2026Sep 2, 2026
A-S Medication SolutionsDARUNAVIR ETHANOLATE 150 mg/1; COBICISTAT 800 mg/1Jul 22, 2026Aug 19, 2026
Janssen Ortho LLCDARUNAVIR ETHANOLATE 150 mg/1; COBICISTAT 800 mg/1Jul 22, 2026Aug 19, 2026
Janssen Products, LPDARUNAVIR ETHANOLATE 150 mg/1; COBICISTAT 800 mg/1Jul 22, 2026Aug 19, 2026
Janssen Products, LPDARUNAVIR ETHANOLATE 150 mg/1; COBICISTAT 675 mg/1Jul 22, 2026Aug 19, 2026
A-S Medication SolutionsCOBICISTAT 150 mg/1; DARUNAVIR ETHANOLATE 800 mg/1Jul 15, 2026Jul 15, 2026
Janssen Ortho LLCCOBICISTAT 150 mg/1; DARUNAVIR ETHANOLATE 800 mg/1Jul 15, 2026Jul 15, 2026
Janssen Products, LPCOBICISTAT 150 mg/1; DARUNAVIR ETHANOLATE 675 mg/1Jul 15, 2026Jul 15, 2026
Janssen Products, LPCOBICISTAT 150 mg/1; DARUNAVIR ETHANOLATE 800 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "darunavir ethanolate and cobicistat — NDC 17314-0812-00," retrieved September 3, 2026, https://drugdashboards.com/drug/17314081200.

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