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.
Zurzuvae
zuranolone · ZURANOLONE 25 mg/1 · Capsule · Oral · Biogen MA Inc.
NDC 64406-0030-01 · 1 BOTTLE in 1 CARTON / 14 CAPSULE in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 64406-0030-02) — 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ⓘ
$617.38per unit
middle half $610.17–$637.54 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$370.43–$463.04
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 92% · step therapy 0% · qty limit 85%
*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.
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 $16,013.10 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA217369
- TE code
- —
- Approval date
- Oct 31, 2023
- Patents / exclusivity
- 15 patents, 3 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NCE | Oct 31, 2028 |
| exclusivity | NCE | Oct 31, 2028 |
| exclusivity | NCE | Oct 31, 2028 |
| patent | 11884696 | Aug 23, 2037 |
| patent | 11884696 | Aug 23, 2037 |
| patent | 11884696 | Aug 23, 2037 |
| patent | 11236121 | Aug 23, 2037 |
| patent | 11236121 | Aug 23, 2037 |
| patent | 11236121 | Aug 23, 2037 |
| patent | 9512165 | Apr 17, 2034 |
| patent | 9512165 | Apr 17, 2034 |
| patent | 10342810 | Apr 17, 2034 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of zuranolone (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Biogen MA Inc. | ZURANOLONE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Biogen MA Inc. | ZURANOLONE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Biogen MA Inc. | ZURANOLONE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent Pharma Solutions, LLC | ZURANOLONE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent Pharma Solutions, LLC | ZURANOLONE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent Pharma Solutions, LLC | ZURANOLONE 30 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, "Zurzuvae — NDC 64406-0030-01," retrieved September 3, 2026, https://drugdashboards.com/drug/64406003001.
Free to cite with attribution — see how the data is put together.