DrugDashboards

Tasigna

nilotinib · NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation

NDC 00078-0526-51 · 28 CAPSULE in 1 BLISTER PACK · NDA · View full market →

The short version

9 companies list this market (plus 1 repackager, which add no supply) — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers classified from DailyMed SPL establishment roles
  • CMS NADAC — latest price vs the price in effect ~12 months earlier
  • FDA drug shortages and enforcement reports (openFDA)
  • FDA inspection classifications; DrugDashboards fragility score and 90-day shortage model
Method

Each sentence is a template that fires only when its condition holds in the data shown lower on this page: maker counts are distinct FDA labelers listing this molecule and dosage form in the last 30 days minus classified repackagers; the price trend compares the newest NADAC with the last price in effect at least 9 months earlier; shortage and recall sentences restate FDA rows for this drug's presentations (Class I/II, trailing 12 months); the plant sentence needs a MANUFACTURE-role establishment with a drug-quality OAI in 24 months; the verdict restates the fragility band; the risk sentence appears only when the model's probability is at least 1.5× the typical market. Nothing here is inferred beyond those rules.

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

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00078-0526-87) — 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ⓘ
$190.03per unit
middle half $186.29–$192.39 · 255 plans · Apr 1, 2026
Est. net of rebatesⓘ
$114.02–$142.52
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 a 25–40% brand range derived from MedPAC's program-wide aggregates to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

ⓘ How this was built
Data sources
  • CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
  • CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
  • CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)
Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

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

$0$50.00$100.00Dec 2015Jun 2016$94.15
3 price points · per unit (archive) · last surveyed Invalid DateSource: CMS NADAC — monthly means to Nov 2024, weekly file after

Estimated fill cost

Estimated WAC per estimate
≈ $97.057
No Texas or California filing exists for this NDC — this figure is derived, not filed.

This is an ESTIMATE derived from NADAC, not a filed or published price: pharmacies typically acquire brand drugs at roughly 2–4% below list, so list ≈ NADAC ÷ 0.97. Shown only because no state transparency filing exists for this NDC.

Medicaid spend (2023)

ⓘ How this was built
Data sources
  • CMS State Drug Utilization Data (SDUD), data.medicaid.gov
Method

CMS's Medicaid Amount Reimbursed for this exact NDC, summed across every state and quarter of the period shown, fee-for-service and managed care together — the program's gross payment to pharmacies before manufacturer rebates (statutory rebates alone recover 23.1% or more of a brand's price). Cells CMS suppresses (fewer than 11 prescriptions in a state-quarter) are absent from the file, so totals for small drugs run low. The prescription count is CMS's Number of Prescriptions. To check: filter the SDUD file for the year to this NDC and sum the column.

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

$279,907
23 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NDCs that have a NADAC price and a generic name.

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
12 patents (12 unexpired), 2 exclusivity codes (2 unexpired)
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application NDA022068, edition retrieved 2026-08-24
Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

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

TypeNumber / codeExpires
exclusivityPEDMar 23, 2029
exclusivityODE-380Sep 23, 2028
patent9061029*PEDOct 7, 2032
patent9061029Apr 7, 2032
patent8163904*PEDFeb 23, 2029
patent8163904Aug 23, 2028
patent8293756*PEDMar 25, 2028
patent8293756Sep 25, 2027
patent8501760*PEDJan 18, 2027
patent8415363*PEDJan 18, 2027
patent8389537*PEDJan 18, 2027
patent8389537Jul 18, 2026
patent8501760Jul 18, 2026
patent8415363Jul 18, 2026

Shortage history

ⓘ How this was built
Data sources
  • FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
  • Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
  • DrugDashboards Kaplan–Meier duration curves and conditional duration model
Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

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

No FDA shortage listing for this drug's presentations in the current file, and no archived episode since 2019.

Recalls (this NDC)

ⓘ How this was built
Data sources
  • FDA drug enforcement reports via openFDA
Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

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

No enforcement reports list this package NDC.

Labelers of nilotinib (Capsule)

10 labelers active in the last 30 days, of which 1 is a repackager; 0not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
  • DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)
Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

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

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

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "Tasigna — NDC 00078-0526-51," retrieved September 4, 2026, https://drugdashboards.com/drug/00078052651.

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