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.
Tasigna
nilotinib · NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation
NDC 00078-0592-51 · 28 CAPSULE in 1 BLISTER PACK · NDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00078-0592-87) — 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ⓘ
$190.52per unit
middle half $182.76–$193.10 · 255 plans · Apr 1, 2026
Est. net of rebatesⓘ
$114.31–$142.89
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
5%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 67%
*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.
Medicaid spend (2025)
$1.1M
61 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Is this a "specialty" drug?
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $16,160.55 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA022068
- TE code
- AB
- Approval date
- Oct 29, 2007
- Patents / exclusivity
- 36 patents, 6 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | PED | Mar 23, 2029 |
| exclusivity | PED | Mar 23, 2029 |
| exclusivity | PED | Mar 23, 2029 |
| exclusivity | ODE-380 | Sep 23, 2028 |
| exclusivity | ODE-380 | Sep 23, 2028 |
| exclusivity | ODE-380 | Sep 23, 2028 |
| patent | 9061029*PED | Oct 7, 2032 |
| patent | 9061029*PED | Oct 7, 2032 |
| patent | 9061029*PED | Oct 7, 2032 |
| patent | 9061029 | Apr 7, 2032 |
| patent | 9061029 | Apr 7, 2032 |
| patent | 9061029 | Apr 7, 2032 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of nilotinib (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Apotex Corp. | NILOTINIB 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp. | NILOTINIB 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp. | NILOTINIB 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | NILOTINIB 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | NILOTINIB 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | NILOTINIB 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | NILOTINIB 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Cipla USA Inc. | NILOTINIB 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Cipla USA Inc. | NILOTINIB 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Cipla USA Inc. | NILOTINIB 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc | NILOTINIB HYDROCHLORIDE MONOHYDRATE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc | NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc | NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Exelan Pharmaceuticals Inc. | NILOTINIB 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Exelan Pharmaceuticals Inc. | NILOTINIB 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Exelan Pharmaceuticals Inc. | NILOTINIB 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | NILOTINIB 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | NILOTINIB 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | NILOTINIB 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharma Stein AG | NILOTINIB 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharma Stein AG | NILOTINIB 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharma Stein AG | NILOTINIB 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharmaceuticals Corporation | NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharmaceuticals Corporation | NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharmaceuticals Corporation | NILOTINIB HYDROCHLORIDE MONOHYDRATE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Torrent Pharmaceuticals Limited | NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Torrent Pharmaceuticals Limited | NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Tasigna — NDC 00078-0592-51," retrieved September 3, 2026, https://drugdashboards.com/drug/00078059251.
Free to cite with attribution — see how the data is put together.