DrugDashboards

Opsynvi

macitentan and tadalafil · MACITENTAN 10 mg/1; TADALAFIL 40 mg/1 · Tablet, Film Coated · Oral · Actelion Pharmaceuticals US, Inc.

NDC 66215-0814-10 · 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK · NDA · View full market →

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.

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)$423.34per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$323.25per unitActelion Pharmaceuticals, U.S. Inc. · Jan 1, 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 66215-0814-30) — 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
$447.96per unit
middle half $424.38$451.56 · 814 plans · Apr 1, 2026
Est. net of rebates
$268.78–$335.97
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
15%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 86%

*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 8 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
$431.83
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.

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 $13,052.38 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA218490
TE code
Approval date
Mar 22, 2024
Patents / exclusivity
12 patents, 6 exclusivities
TypeNumber / codeExpires
exclusivityPEDSep 22, 2031
exclusivityPEDSep 22, 2031
exclusivityODE-475Mar 22, 2031
exclusivityODE-475Mar 22, 2031
exclusivityNPMar 22, 2027
exclusivityNPMar 22, 2027
patent8268847*PEDOct 18, 2029
patent8268847*PEDOct 18, 2029
patent8268847Apr 18, 2029
patent8268847Apr 18, 2029
patent10946015*PEDMar 11, 2027
patent10946015*PEDMar 11, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of macitentan and tadalafil (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Actelion Pharmaceuticals US, Inc.MACITENTAN 10 mg/1; TADALAFIL 20 mg/1Jul 15, 2026Sep 2, 2026
Actelion Pharmaceuticals US, Inc.MACITENTAN 10 mg/1; TADALAFIL 40 mg/1Jul 15, 2026Sep 2, 2026
Penn Pharmaceutical Services LimitedMACITENTAN 10 mg/1; TADALAFIL 20 mg/1Jul 15, 2026Sep 2, 2026
Penn Pharmaceutical Services LimitedMACITENTAN 10 mg/1; TADALAFIL 40 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Opsynvi — NDC 66215-0814-10," retrieved September 3, 2026, https://drugdashboards.com/drug/66215081410.

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