Medicare Part D spending · FDA facts · help paying
Synjardy XR (empagliflozin, 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 Synjardy XR of $320.73 million in 2024, across 310,733 claims and 70,976 beneficiaries. 2 assistance programs list empagliflozin, metformin hydrochloride, each with its income ceiling and when we read it. 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 3 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 |
|---|---|---|---|---|---|
| NDA208658 | Synjardy Xr | December 11, 2034 | December 20, 2026 | December 11, 2034 | patent 9949998 with its pediatric extension; 104 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 Synjardy XR of $320.73 million in 2024, across 310,733 claims and 70,976 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 | $320.73 million | 310,733 | 70,976 | $1,032 |
| 2023 | $278.42 million | 252,620 | 58,868 | $1,102 |
| 2022 | $206.95 million | 202,183 | 47,124 | $1,024 |
| 2021 | $142.73 million | 152,660 | 35,523 | $935 |
| 2020 | $89.48 million | 106,841 | 24,248 | $838 |
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 12 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 |
|---|---|---|---|
| FL | 624 | $400,322 | Fee-for-service only |
| MI | 404 | $269,733 | Fee-for-service only |
| NC | 197 | $197,346 | Fee-for-service only |
| MS | 276 | $154,365 | Fee-for-service only |
| MA | 153 | $98,403 | Fee-for-service only |
| UT | 109 | $93,603 | Fee-for-service only |
| CO | 105 | $91,387 | All record types |
| LA | 90 | $46,088 | All record types |
| VA | 71 | $38,079 | All record types |
| KS | 70 | $37,733 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (14 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. 99 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 $40.31 million for Synjardy 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 | $40.31 million | 55,671 |
| 2023 | $31.65 million | 41,779 |
| 2022 | $20.67 million | 29,777 |
| 2021 | $13.08 million | 21,022 |
| 2020 | $8.81 million | 15,703 |
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.
Where help paying exists
Programs in our finder that list empagliflozin, metformin hydrochloride. Each shows its income ceiling, when we read it and whether we checked it against the program's own document. Eligibility is decided by the program, not by us.
- Boehringer Ingelheim Cares Foundation manufacturer
Income at or below 250% FPL ($39,900 for one person), or 200% ($31,920) for the Respimat inhalers. Since 15 October 2026 no new Medicare Part D or Advantage enrollments for its primary care products, including Jardiance
Ceiling read on the program's own document, November 6, 2026.Status. 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. (read November 6, 2026)
- Jardiance Savings Card (BI/Lilly) manufacturer
No income limit in our data
Figure not yet re-read on the program's own page.
Check where your income sits against each ceiling: open the assistance finder. See what has changed and when we last verified each program on the program status board.
Label changes
FDA actions on the applications behind Synjardy 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 | NDA208658 | 38 | 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 Synjardy XR by its NDC: 3 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 |
|---|---|---|---|---|---|
| July 8, 2026D-0657-2026 | Class II | Ongoing | Boehringer Ingelheim Pharmaceuticals, Inc. | CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product. | 1 |
| June 2, 2021D-0458-2021 | Class II | Terminated | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | 10 |
| June 2, 2021D-0459-2021 | Class II | Terminated | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | 10 |
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 Synjardy XR?
The CMS negotiated-price file we read does not list Synjardy 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 Synjardy XR?
2 assistance programs list it in our finder. Eligibility depends on income, coverage and the program's current rules; each program's own page decides.
When could a generic version of Synjardy XR arrive?
For Synjardy XR, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA208658, December 11, 2034. 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 Synjardy XR?
CMS's Medicare Part D spending dataset reports gross spending on Synjardy XR of $320.73 million in 2024, across 310,733 claims and 70,976 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/synjardy-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; 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.