Medicare Part D spending · FDA facts · help paying
Spiriva Handihaler (tiotropium bromide): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Spiriva Handihaler of $486.26 million in 2024, across 619,477 claims and 157,377 beneficiaries. A program that covered this drug has changed its terms; the details and the source are below. The FDA's enforcement reports name this drug's packages in 5 recall entries.
When could a generic arrive
Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
| Application | Product | Latest listed patent expiry | Latest listed exclusivity expiry | Latest of the two | Set by |
|---|---|---|---|---|---|
| NDA021395 | Spiriva Handihaler | July 19, 2026 | none listed | July 19, 2026 | patent 8022082 with its pediatric extension; 2 dated entries listed |
A listed date that has already passed does not mean a generic has launched; it means no listed patent or exclusivity runs past it.
Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Spiriva Handihaler of $486.26 million in 2024, across 619,477 claims and 157,377 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $486.26 million | 619,477 | 157,377 | $785 |
| 2023 | $782.93 million | 946,781 | 236,984 | $827 |
| 2022 | $935.52 million | 1,181,232 | 280,582 | $792 |
| 2021 | $1.04 billion | 1,375,217 | 323,646 | $753 |
| 2020 | $1.15 billion | 1,644,087 | 371,913 | $702 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 1 designation for Tiotropium bromide. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.
| Designated | Designated use | Status | Sponsor |
|---|---|---|---|
| January 8, 2008 | To improve pulmonary function in conjunction with standard therapy in the management of patients with cystic fibrosis | Designated/Designation Withdrawn or Revoked | Boehringer Ingelheim Pharmaceuticals, Inc. |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 1 states with the largest reimbursement are shown. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| NV | 64 | $15,310 | All record types |
A state missing from the table means its figures were suppressed or not reported, not zero use. 80 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Medicaid spending
CMS's Medicaid spending dataset reports $190.82 million for Spiriva Handihaler in 2024. CMS's dataset states spending includes Federal and State reimbursement and dispensing fees and is not reduced by Medicaid rebates paid to the states. Spending is what Medicaid paid, not what a patient pays.
| Year | Spending | Claims |
|---|---|---|
| 2024 | $190.82 million | 337,301 |
| 2023 | $269.60 million | 472,627 |
| 2022 | $333.41 million | 599,713 |
| 2021 | $358.57 million | 677,391 |
| 2020 | $320.24 million | 657,571 |
Source: CMS Medicaid spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. A national drug-level aggregate; it says nothing about any state's coverage rules.
Federal formulary status
TRICARE
The Defense Health Agency's TRICARE formulary files include 4 packages of Spiriva Handihaler in the uniform formulary class PULMONARY-2 AGENTS. Each row counts packages by the list that names them and the status it gives. A status is a TRICARE listing, not a statement about what a plan will pay for you.
| List | Status | Packages |
|---|---|---|
| Basic/Extended Core Formulary | BASIC CORE | 4 |
Source: TRICARE formulary files (tricare-formulary-2026-10), read November 7, 2026. TRICARE formulary page.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
The FDA file lists no non-manufacturing label change for these applications since November 11, 2025. The most recent one it lists is dated December 30, 2024 (Labeling).
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Safety notices
FDA enforcement report entries that name a package of Spiriva Handihaler by its NDC: 5 entries, newest first. FDA assigns each a class by health risk: Class I is the most serious and Class III the least. An entry records what the recalling firm reported and FDA classified; it is not advice about any package you hold.
| Reported | Class | Status | Recalling firm | Reason (shortened) | Packages named |
|---|---|---|---|---|---|
| January 3, 2024D-0197-2024 | Class II | Terminated | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | 3 |
| June 2, 2021D-0453-2021 | Class II | Terminated | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | 3 |
| February 7, 2018D-0242-2018 | Class II | Terminated | Boehringer Ingelheim Pharmaceuticals, Inc. | Failed Stability Specifications | 3 |
| April 16, 2014D-1230-2014 | Class III | Terminated | Boehringer Ingelheim Roxane Inc | Defective 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. | 3 |
| September 25, 2013D-1057-2013 | Class III | Terminated | Boehringer Ingelheim Roxane Inc | Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler | 3 |
Source: openFDA drug enforcement reports, file read November 7, 2026. openFDA data file. All recent recalls across these drugs: drug recalls feed.
Questions
Does Medicare have a negotiated price for Spiriva Handihaler?
The CMS negotiated-price file we read does not list Spiriva Handihaler, so this page shows no negotiated price. A drug appears in that file only when CMS selects it for negotiation, and not being listed says nothing about what it costs a patient.
Is there help paying for Spiriva Handihaler?
No program in our finder currently lists it as open to new patients. No new patient enrollments for individuals with Medicare Part D or Medicare Advantage prescription drug coverage for Boehringer Ingelheim primary care products (Combivent Respimat, Glyxambi, Jardiance, Jentadueto, Jentadueto XR, Spiriva Respimat, Stiolto Respimat, Synjardy, Synjardy XR, Tradjenta, Trijardy XR). Part D patients actively enrolled as of 2026-10-15 continue through their current enrollment period and may be eligible in 2027 only after annual re-enrollment. Product removals: Cyltezo 2026-07-15; OFEV 2026-09-11 (active patients continue through the end of their enrollment or 2027-12-31); no new enrollments for Aptivus, Atrovent and Striverdi from 2026-10-15.
When could a generic version of Spiriva Handihaler arrive?
For Spiriva Handihaler, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA021395, July 19, 2026. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
How much does Medicare Part D spend on Spiriva Handihaler?
CMS's Medicare Part D spending dataset reports gross spending on Spiriva Handihaler of $486.26 million in 2024, across 619,477 claims and 157,377 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns the generic-entry upper bound, label history, recalls, trials, assistance and Part D spending, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/spiriva-handihaler.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. This drug is not in the CMS negotiated-price file, so no price source is used. Program details read from each program's own pages; CMS Medicare Part D spending by drug; CMS Medicaid spending by drug; TRICARE and VA formulary files; FDA Drugs@FDA and Orange Book data files; openFDA drug enforcement reports. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.