DrugDashboards

Nilotinib

Nilotinib · NILOTINIB 150 mg/1 · Capsule · Oral · Cipla USA Inc.

NDC 69097-0031-74 · 4 CARTON in 1 CARTON / 4 BLISTER PACK in 1 CARTON / 7 CAPSULE in 1 BLISTER PACK · NDA · 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 →
ⓘ 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
$184.24per unit
middle half $184.24$190.98 · 1,985 plans · Apr 1, 2026
Est. net of rebates
$110.54–$138.18
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
36%of plans cover it
tier 5 · prior auth 95% · step therapy 0% · qty limit 86%

*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 1 quarter 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.

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 · median tier 5 across plans
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA218922
TE code
Approval date
Feb 19, 2025
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · OngoingFeb 18, 2026
    Cipla USA, Inc.Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
  • Class III · OngoingFeb 18, 2026
    Cipla USA, Inc.Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Manufacturers of Nilotinib (Capsule)

LabelerStrengthFirst seenLast seen
Apotex Corp.NILOTINIB 200 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.NILOTINIB 150 mg/1Jul 15, 2026Sep 2, 2026
Apotex Corp.NILOTINIB 50 mg/1Jul 15, 2026Sep 2, 2026
AvKARENILOTINIB 150 mg/1Jul 15, 2026Sep 2, 2026
AvKARENILOTINIB 200 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.NILOTINIB 200 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.NILOTINIB 150 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.NILOTINIB 200 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.NILOTINIB 150 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.NILOTINIB 50 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories IncNILOTINIB HYDROCHLORIDE MONOHYDRATE 50 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories IncNILOTINIB HYDROCHLORIDE MONOHYDRATE 150 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories IncNILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1Jul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.NILOTINIB 200 mg/1Jul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.NILOTINIB 150 mg/1Jul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.NILOTINIB 50 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCNILOTINIB 150 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCNILOTINIB 50 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCNILOTINIB 200 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharma Stein AGNILOTINIB 200 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharma Stein AGNILOTINIB 150 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharma Stein AGNILOTINIB 50 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationNILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationNILOTINIB HYDROCHLORIDE MONOHYDRATE 150 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationNILOTINIB HYDROCHLORIDE MONOHYDRATE 50 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedNILOTINIB HYDROCHLORIDE MONOHYDRATE 150 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedNILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Nilotinib — NDC 69097-0031-74," retrieved September 3, 2026, https://drugdashboards.com/drug/69097003174.

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