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.
Macitentan
Macitentan · MACITENTAN 10 mg/1 · Tablet, Film Coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC 70710-1166-03 · 30 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 66215-0501-30) — 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ⓘ
$447.42per unit
middle half $443.55–$463.05 · 4,395 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $447.42
generic — rebates are minimal, so net ≈ gross
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.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · manufacture · pack
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 $12,679.08 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA211224
- TE code
- AB
- Approval date
- Apr 6, 2021
- Patents / exclusivity
- 0 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | PC | Dec 3, 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 Macitentan (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp. | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Excella GmbH & Co. KG | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Laurus Labs Limited | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novugen Pharma (USA) LLC | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sandoz Inc | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals, Inc. | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | MACITENTAN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Macitentan — NDC 70710-1166-03," retrieved September 3, 2026, https://drugdashboards.com/drug/70710116603.
Free to cite with attribution — see how the data is put together.