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.
Wayrilz
rilzabrutinib · RILZABRUTINIB 400 mg/1 · Tablet, Film Coated · Oral · Genzyme Corporation
NDC 58468-0251-05 · 2 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 58468-0251-06) — 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ⓘ
$278.41per unit
middle half $278.41–$300.99 · 19 plans · Apr 1, 2026
Est. net of rebatesⓘ
$167.04–$208.81
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
0%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 47%
*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 2 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
- Flamma S.p.A.Italyapi manufacture
- Flamma SpAItalyapi manufacture
- Genzyme CorporationUnited Statesanalysis · label · pack
- Patheon Inc.Canadaanalysis · label · manufacture · pack
- Sanofi S.r.l.Italyanalysis · label · 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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA219685
- TE code
- —
- Approval date
- Aug 29, 2025
- Patents / exclusivity
- 6 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-552 | Aug 29, 2032 |
| exclusivity | NCE | Aug 29, 2030 |
| patent | 11708370 | Feb 20, 2041 |
| patent | 12178818 | Oct 13, 2040 |
| patent | 8940744 | Sep 6, 2033 |
| patent | 9266895 | Sep 6, 2033 |
| patent | 9994576 | Sep 6, 2033 |
| patent | 9580427 | Mar 1, 2033 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of rilzabrutinib (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Genzyme Corporation | RILZABRUTINIB 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sanofi S.r.l. | RILZABRUTINIB 400 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, "Wayrilz — NDC 58468-0251-05," retrieved September 3, 2026, https://drugdashboards.com/drug/58468025105.
Free to cite with attribution — see how the data is put together.