Medicare Part D spending · FDA facts · help paying
Xigduo XR (dapagliflozin and metformin hydrochloride): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Xigduo XR of $203.53 million in 2024, across 215,012 claims and 46,616 beneficiaries. A program that covered this drug has changed its terms; the details and the source are below. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 2 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 |
|---|---|---|---|---|---|
| NDA205649 | Dapagliflozin And Metformin Hydrochloride, Xigduo Xr | May 12, 2031 | December 12, 2027 | May 12, 2031 | patent 9616028 with its pediatric extension; 60 dated entries listed |
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 Xigduo XR of $203.53 million in 2024, across 215,012 claims and 46,616 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 | $203.53 million | 215,012 | 46,616 | $947 |
| 2023 | $198.89 million | 196,444 | 43,054 | $1,012 |
| 2022 | $153.80 million | 161,366 | 35,699 | $953 |
| 2021 | $114.23 million | 129,660 | 29,188 | $881 |
| 2020 | $73.87 million | 93,057 | 19,955 | $794 |
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.
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 10 states with the largest reimbursement are shown of 16 with data. 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 |
|---|---|---|---|
| TX | 1,074 | $572,148 | Fee-for-service only |
| NV | 528 | $249,436 | All record types |
| MD | 555 | $224,986 | Fee-for-service only |
| SC | 339 | $212,188 | Fee-for-service only |
| OK | 170 | $128,951 | All record types |
| OH | 135 | $72,857 | All record types |
| UT | 134 | $71,492 | Fee-for-service only |
| PA | 65 | $52,362 | Fee-for-service only |
| GA | 128 | $49,318 | Fee-for-service only |
| OR | 80 | $47,336 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (7 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 95 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 $27.04 million for Xigduo XR 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 | $27.04 million | 36,585 |
| 2023 | $27.84 million | 40,421 |
| 2022 | $20.52 million | 31,985 |
| 2021 | $12.75 million | 21,476 |
| 2020 | $7.24 million | 13,146 |
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 7 packages of Xigduo XR in the uniform formulary class DIABETES NON-INSULIN. 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 | 7 |
| Tier 4 / Not Covered Drug List | NOT COVERED | 7 |
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
FDA actions on the applications behind Xigduo XR dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| August 11, 2026 | Labeling | NDA205649 | 28, 29 | Label (PDF) posted August 18, 2026FDA letter posted August 14, 2026 |
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 Xigduo XR by its NDC: 2 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 |
|---|---|---|---|---|---|
| June 2, 2021D-0435-2021 | Class II | Terminated | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | 7 |
| June 2, 2021D-0436-2021 | Class II | Terminated | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | 7 |
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 Xigduo XR?
The CMS negotiated-price file we read does not list Xigduo XR, 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 Xigduo XR?
No program in our finder currently lists it as open to new patients. AZ&Me no longer accepts new patients for FARXIGA and XIGDUO XR from 2026-05-01; actively enrolled patients continue until 2026-12-31; the notice says generic equivalents became available beginning in April 2026 and that the products will be removed from the program by the end of 2026; communications went to enrolled patients and providers in April 2026
When could a generic version of Xigduo XR arrive?
For Xigduo XR, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA205649, May 12, 2031. 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 Xigduo XR?
CMS's Medicare Part D spending dataset reports gross spending on Xigduo XR of $203.53 million in 2024, across 215,012 claims and 46,616 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/xigduo-xr.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.