DrugDashboards

Opsumit

macitentan · MACITENTAN 10 mg/1 · Tablet, Film Coated · Oral · Actelion Pharmaceuticals US, Inc.

NDC 66215-0501-30 · 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply.

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)$420.29per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$447.42per unitnegotiated price across 4,395 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$261.40per unitActelion Pharmaceuticals, U.S. Inc. · Jan 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
$447.42per unit
middle half $443.55$463.05 · 4,395 plans · Apr 1, 2026
Est. net of rebates
$268.45–$335.56
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
80%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 73%

*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.

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.

Medicaid spend (2025)

$227.7M
18,132 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 · median tier 5 across plans
  • Costs ≥ $950/fill · avg $12,679.08 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA204410
TE code
AB
Approval date
Oct 18, 2013
Patents / exclusivity
10 patents, 2 exclusivities
TypeNumber / codeExpires
exclusivityPEDAug 28, 2028
exclusivityM-187Feb 28, 2028
patent8268847*PEDOct 18, 2029
patent8268847Apr 18, 2029
patent8367685*PEDApr 4, 2029
patent8367685Oct 4, 2028
patent9265762*PEDNov 29, 2027
patent9265762May 29, 2027
patent10946015*PEDMar 11, 2027
patent10946015Sep 11, 2026
patent7094781*PEDJun 5, 2026
patent7094781Dec 5, 2025

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 (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Actelion Pharmaceuticals US, Inc.MACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.MACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedMACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCMACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.MACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedMACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Excella GmbH & Co. KGMACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedMACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.MACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Novugen Pharma (USA) LLCMACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncMACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.MACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.MACITENTAN 10 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Opsumit — NDC 66215-0501-30," retrieved September 3, 2026, https://drugdashboards.com/drug/66215050130.

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