DrugDashboards

Biktarvy

bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate · BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 · Tablet · Oral · A-S Medication Solutions

NDC 50090-6247-00 · 30 TABLET in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 61958-2501-01) — 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
$136.05per unit
middle half $133.66$140.89 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$81.63–$102.04
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 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 bictegravir sodium, emtricitabine, and tenofovir alafenamide 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 →

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
  • Costs ≥ $950/fill · avg $4,110.58 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA210251
TE code
Approval date
Feb 7, 2018
Patents / exclusivity
20 patents, 9 exclusivities
TypeNumber / codeExpires
exclusivityODE-540Jul 30, 2032
exclusivityODE-540Jul 30, 2032
exclusivityODE-468Feb 23, 2031
exclusivityODE-468Feb 23, 2031
exclusivityODE-378Oct 7, 2028
exclusivityM-305Apr 24, 2027
exclusivityI-942Feb 23, 2027
exclusivityI-942Feb 23, 2027
exclusivityODE-256Jun 18, 2026
patent11744802Nov 8, 2036
patent12594244Nov 8, 2036
patent10548846Nov 8, 2036

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate (Tablet)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsBICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1Jul 15, 2026Sep 2, 2026
Gilead Sciences, Inc.BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1Jul 15, 2026Sep 2, 2026
Patheon Inc.BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1Jul 15, 2026Sep 2, 2026
Rottendorf Pharma GmbHBICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1Jul 15, 2026Sep 2, 2026
Takeda GmbHBICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1Jul 15, 2026Sep 2, 2026
Gilead Sciences, Inc.BICTEGRAVIR SODIUM 30 mg/1; EMTRICITABINE 120 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 15 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Biktarvy — NDC 50090-6247-00," retrieved September 3, 2026, https://drugdashboards.com/drug/50090624700.

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