DrugDashboards

Spiriva HandiHaler

Tiotropium Bromide · TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1 · Capsule · Oral; Respiratory (Inhalation) · Boehringer Ingelheim Pharmaceuticals, Inc.

NDC 00597-0075-75 · 1 BLISTER PACK in 1 CARTON / 5 CAPSULE in 1 BLISTER PACK · NDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The brand price has held steady around $11.73 per unit over the past year. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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.

  • Pharmacies pay (NADAC)$11.74per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$16.60per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$7.45per unitBoehringer Ingelheim Pharmaceuticals, Inc. · Jan 1, 202664% of what pharmacies pay — a deeper discount than 81% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00597-0075-41) — 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
$10.66per unit
middle half $10.59$12.41 · 2,284 plans · Apr 1, 2026
Est. net of rebates
$6.39–$7.99
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
42%of plans cover it
tier 3 · prior auth 0% · step therapy 0% · qty limit 99%

*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

$0$10.00$20.00Feb 2014Sep 2026$11.73
29 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$352.05
#90 count
$1056.15

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$329,544
1,210 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

10Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for tiotropium bromide (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Regulatory

Application
NDA021395
TE code
AB
Approval date
Jan 30, 2004
Patents / exclusivity
2 patents, 0 exclusivities
TypeNumber / codeExpires
patent8022082*PEDJul 19, 2026
patent8022082Jan 19, 2026

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedJan 26, 2022
    CARDINAL HEALTHCARECGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
  • Class II · TerminatedMar 15, 2021
    Cardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.
  • Class II · TerminatedDec 14, 2017
    Boehringer Ingelheim Pharmaceuticals, Inc.Failed Stability Specifications
  • Class III · TerminatedMar 27, 2014
    Boehringer Ingelheim Roxane IncDefective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
  • Class III · TerminatedAug 30, 2013
    Boehringer Ingelheim Roxane IncPresence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler

Manufacturers of Tiotropium Bromide (Capsule)

LabelerStrengthFirst seenLast seen
Boehringer Ingelheim Pharmaceuticals, Inc.TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1Jul 15, 2026Sep 2, 2026
A-S Medication SolutionsTIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Spiriva HandiHaler — NDC 00597-0075-75," retrieved September 3, 2026, https://drugdashboards.com/drug/00597007575.

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