DrugDashboards

Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate

Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate · EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 · Tablet, Film Coated · Oral · Mylan Pharmaceuticals Inc.

NDC 00378-5440-93 · 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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)$114.50per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D point of sale (median)$103.88per unitnegotiated price across 5,496 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
$103.88per unit
middle half $90.12$114.08 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $103.88
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 0% · step therapy 0% · qty limit 55%

*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 4 quarters since 2024.

NADAC price per unit

$0$50.00$100.00$150.00Feb 2026Sep 2026$114.50
7 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$3435.09
#90 count
$10305.27

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

Medicaid spend (2025)

$1.3M
399 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

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 emtricitabine, rilpivirine and tenofovir disoproxil fumarate (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 1 of 6 public criteria. Why that matters →

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

Regulatory

Application
ANDA208452
TE code
AB
Approval date
May 20, 2025
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Mylan Pharmaceuticals Inc.EMTRICITABINE 200 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate — NDC 00378-5440-93," retrieved September 3, 2026, https://drugdashboards.com/drug/00378544093.

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