The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Symtuza
Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide · DARUNAVIR 800 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg/1 · Tablet, Film Coated · Oral · Janssen Products LP
NDC 59676-0800-99 · 30 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 59676-0800-30) — 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ⓘ
$150.73per unit
middle half $149.01–$156.32 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$90.44–$113.05
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 53%
*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, cobicistat, emtricitabine, and tenofovir alafenamide (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
- AMPAC Fine Chemicals LLCUnited Statesapi manufacture
- Esteve Quimica, S.A.Spainapi manufacture
- Evonik Operations GmbHGermanyapi manufacture
- Gilead Alberta ULCCanadaapi manufacture
- Janssen Cilag SpAItalymanufacture · pack
- Janssen Ortho LLCUnited Statespack
- Janssen Pharmaceutica NVBelgiummanufacture
- analysis · api manufacture
- Janssen Pharmaceuticals Inc.United Statesanalysis
- Patheon Inc.Canadaanalysis · manufacture
- api manufacture
- api manufacture
- api manufacture
- Yuhan Chemical Inc.Korea, Southapi manufacture
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 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $4,925.50 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA210455
- TE code
- —
- Approval date
- Jul 17, 2018
- Patents / exclusivity
- 6 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 10786518 | Jul 19, 2038 |
| patent | 10039718 | Oct 6, 2032 |
| patent | 8754065 | Aug 15, 2032 |
| patent | 9296769 | Aug 15, 2032 |
| patent | 8148374 | Sep 3, 2029 |
| patent | 7700645 | Dec 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, Cobicistat, Emtricitabine, and Tenofovir alafenamide (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Patheon Inc. | DARUNAVIR 800 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Janssen Products LP | DARUNAVIR 800 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Janssen Products LP | DARUNAVIR 150 mg/1; COBICISTAT 800 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Patheon Inc. | DARUNAVIR 150 mg/1; COBICISTAT 800 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Janssen Products LP | COBICISTAT 150 mg/1; DARUNAVIR 800 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Patheon Inc. | COBICISTAT 150 mg/1; DARUNAVIR 800 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE 10 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Symtuza — NDC 59676-0800-99," retrieved September 3, 2026, https://drugdashboards.com/drug/59676080099.
Free to cite with attribution — see how the data is put together.