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.
Calquence
acalabrutinib · ACALABRUTINIB 100 mg/1 · Tablet, Film Coated · Oral · AstraZeneca Pharmaceuticals LP
NDC 00310-4513-60 · 60 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00310-3512-60) — 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ⓘ
$259.48per unit
middle half $255.43–$270.58 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$155.69–$194.61
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · qty limit 93%
*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 $13,910.02 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA216387
- TE code
- —
- Approval date
- Aug 3, 2022
- Patents / exclusivity
- 8 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | D-200 | Feb 19, 2029 |
| exclusivity | I-960 | Jan 16, 2028 |
| patent | 11059829 | Jul 1, 2036 |
| patent | 11166951 | Aug 11, 2035 |
| patent | 11771696 | Jan 21, 2035 |
| patent | 10272083 | Jan 21, 2035 |
| patent | 10239883 | Jul 11, 2032 |
| patent | 9290504 | Jul 11, 2032 |
| patent | 9758524 | Jul 11, 2032 |
| patent | 7459554 | Nov 24, 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 acalabrutinib (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | ACALABRUTINIB 100 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| AstraZeneca AB | ACALABRUTINIB MALEATE ANHYDROUS 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AstraZeneca Pharmaceuticals LP | ACALABRUTINIB MALEATE ANHYDROUS 100 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, "Calquence — NDC 00310-4513-60," retrieved September 3, 2026, https://drugdashboards.com/drug/00310451360.
Free to cite with attribution — see how the data is put together.