DrugDashboards

Sunitinib malate

Sunitinib malate · SUNITINIB MALATE 50 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries Inc.

NDC 63304-0094-27 · 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Part D plans paid (avg)$246.26per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$252.46per unitnegotiated price across 5,496 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ 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
$252.46per unit
middle half $201.47$314.44 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $252.46
generic — rebates are minimal, so net ≈ gross
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.

Estimated fill cost

WAC per package, as filed
$14,452.96
Reported to Texas DSHS · 2026 annual filing · Sun Pharma

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

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $5,922.78 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA213914
TE code
AB
Approval date
Aug 16, 2021
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 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 63304-0094-27," retrieved September 3, 2026, https://drugdashboards.com/drug/63304009427.

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