DrugDashboards

Sunitinib Malate

Sunitinib Malate · SUNITINIB MALATE 12.5 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.

NDC 00093-8199-28 · 28 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

10 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 00069-0550-38) — 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ⓘ
$226.99per unit
middle half $226.99–$226.99 · 2 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $226.99
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 100% · step therapy 0% · qty limit 100%

*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.

Estimated fill cost

WAC per package, as filed
$4,889.07
Reported to Texas DSHS · 2026 annual filing · Teva Pharmaceuticals USA, Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

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 $5,922.78 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA213803
TE code
AB
Approval date
Nov 30, 2021
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedJul 5, 2023
    Teva Pharmaceuticals USA Inc — Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Manufacturers of Sunitinib Malate (Capsule)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedSUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedSUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedSUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedSUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
AvKARESUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
AvKARESUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
AvKARESUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
AvKARESUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncSUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncSUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncSUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncSUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.SUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.SUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.SUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.SUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCSUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCSUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCSUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCSUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCSUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCSUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCSUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCSUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
Novugen Pharma (USA) LLC.SUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
Novugen Pharma (USA) LLC.SUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Novugen Pharma (USA) LLC.SUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
Novugen Pharma (USA) LLC.SUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncSUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncSUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncSUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncSUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries Inc.SUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries Inc.SUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries Inc.SUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries Inc.SUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.SUNITINIB MALATE 37.5 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.SUNITINIB MALATE 12.5 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.SUNITINIB MALATE 50 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.SUNITINIB MALATE 25 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Sunitinib Malate — NDC 00093-8199-28," retrieved September 3, 2026, https://drugdashboards.com/drug/00093819928.

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