DrugDashboards

Abiraterone Acetate

Abiraterone Acetate · ABIRATERONE ACETATE 250 mg/1 · Tablet · Oral · Dr. Reddys Laboratories Inc

NDC 43598-0358-31 · 3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK · ANDA · View full market →

The short version

19 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 82249-0011-12) — 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
$0.9028per unit
middle half $0.7674$0.9389 · 4,996 plans · Apr 1, 2026
Est. net of rebates
≈ $0.9028
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
91%of plans cover it
tier 4 · prior auth 79% · step therapy 0% · qty limit 81%

*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 4 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.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for abiraterone acetate (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

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 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,779.54 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA208416
TE code
AB
Approval date
May 18, 2020
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Abiraterone Acetate (Tablet)

LabelerStrengthFirst seenLast seen
Dr. Reddys Laboratories IncABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 3, 2026
Apotex Corp.ABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
AvPAKABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesABIRATERONE ACETATE 500 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories IncABIRATERONE ACETATE 500 mg/1Jul 15, 2026Sep 2, 2026
Florida Pharmaceutical Products, LLC.ABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USAABIRATERONE ACETATE 500 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USAABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.ABIRATERONE ACETATE 125 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Janssen Biotech, Inc.ABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.ABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
NorthStar Rx LLCABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Northstar Rx LlcABIRATERONE ACETATE 500 mg/1Jul 15, 2026Sep 2, 2026
Northstar Rx LlcABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
PD-Rx Pharmaceuticals, Inc.ABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health LLCABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.ABIRATERONE ACETATE 250 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.ABIRATERONE ACETATE 125 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript, LLCABIRATERONE ACETATE 250 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Abiraterone Acetate — NDC 43598-0358-31," retrieved September 3, 2026, https://drugdashboards.com/drug/43598035831.

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