Medicare Part D spending · FDA facts · help paying
Pradaxa (dabigatran etexilate mesylate): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Pradaxa of $123.18 million in 2024, across 481,836 claims and 139,514 beneficiaries.
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 |
|---|---|---|---|---|---|
| NDA022512 | Pradaxa | July 20, 2031 | none listed | July 20, 2031 | patent 9034822 with its pediatric extension; 12 dated entries listed |
| NDA214358 | Pradaxa | March 7, 2026 | none listed | March 7, 2026 | patent 7932273 with its pediatric extension; 12 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 Pradaxa of $123.18 million in 2024, across 481,836 claims and 139,514 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 | $123.18 million | 481,836 | 139,514 | $256 |
| 2023 | $176.22 million | 536,887 | 144,821 | $328 |
| 2022 | $469.90 million | 733,966 | 172,740 | $640 |
| 2021 | $571.02 million | 806,337 | 177,065 | $708 |
| 2020 | $599.58 million | 909,807 | 184,747 | $659 |
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.
FDA safety program (REMS)
- Pradaxa (application NDA022512): listed as released, without Elements to Assure Safe Use. Program dated October 19, 2010, last modified April 5, 2011. REMS@FDA program page.
A REMS is a safety program the FDA can require for a drug. Some restrict how it is prescribed or dispensed, for example through certified prescribers or pharmacies. This lists what the FDA's REMS@FDA files tie to the application; it does not say which prescribers or pharmacies take part, or whether a given patient needs the program.
Source: FDA REMS@FDA data files (rems-fda-files-2026-11-07-products-20a9945448dd), read November 7, 2026. REMS@FDA product file.
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 2 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 |
|---|---|---|---|
| ME | 92 | $18,996 | All record types |
| SC | 62 | $12,089 | Fee-for-service only |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (1 state and package figure is marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 65 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 $8.72 million for Pradaxa 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 | $8.72 million | 30,030 |
| 2023 | $13.71 million | 31,278 |
| 2022 | $25.57 million | 43,568 |
| 2021 | $22.60 million | 49,061 |
| 2020 | $21.86 million | 49,905 |
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 6 packages of Pradaxa in the uniform formulary class ANTICOAGULANTS. 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 |
|---|---|---|
| Non-Formulary Drug List | NON-FORMULARY | 6 |
| Tier 4 / Not Covered Drug List | NOT COVERED | 6 |
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 June 17, 2025 (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.
Questions
Does Medicare have a negotiated price for Pradaxa?
The CMS negotiated-price file we read does not list Pradaxa, 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 Pradaxa?
No program in our finder lists this drug yet.
When could a generic version of Pradaxa arrive?
For Pradaxa, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA022512, July 20, 2031; NDA214358, March 7, 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 Pradaxa?
CMS's Medicare Part D spending dataset reports gross spending on Pradaxa of $123.18 million in 2024, across 481,836 claims and 139,514 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/pradaxa.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. 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.