Pillstats
Rx only · Capsule · Oral

Sunitinib Malate

Brands: Sutent · Sunitinib Malate

9 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US40 NDCs
9 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)357977
US makers10 labelers
Packages52
DEA / ScheduleNone

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

2857851142025 Q12025 Q22025 Q32025 Q42026 Q1
52
Rx · 2026 Q1
1.5K
Units dispensed
-47%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it9 active · 1 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Aurobindo Pharma Limitedunknown8SUPPLYING
SUN PHARMACEUTICAL INDUSTRIES, INC.unknown8SUPPLYING
Dr.Reddy's laboratories Limitedunknown8SUPPLYING
Novugen Pharma (USA) LLC.unknown4SUPPLYING
Novadoz Pharmaceuticals LLCunknown4SUPPLYING
Mylan Pharmaceuticals Inc.unknown4SUPPLYING
Pfizer Laboratories Div Pfizer Incunknown4SUPPLYING
AvKAREunknown4SUPPLYING
Teva Pharmaceuticals USA, Inc.unknown4SUPPLYING
NorthStar RxLLCunknown4EXITED 2026

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Oct 18, 2024
    RECALLRecall (Class II): Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-9…

    Labeling: Label Mix-Up — Recalling firm: AvKARE — Nationwide within the United States

  • Oct 18, 2024
    RECALLRecall (Class II): Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-90…

    Labeling: Label Mix-Up — Recalling firm: AvKARE — Nationwide within the United States

  • Jul 5, 2023
    RECALLRecall (Class II): Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsipp…

    Failed Moisture Limits: Water (moisture) content above the approved product specifications. — Recalling firm: Teva Pharmaceuticals USA Inc — Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.