Medicare Part D spending · FDA facts · help paying
Belbuca (buprenorphine hydrochloride): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Belbuca of $160.14 million in 2024, across 217,647 claims and 38,169 beneficiaries. 2 non-manufacturing label changes are 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 |
|---|---|---|---|---|---|
| NDA207932 | Belbuca | December 21, 2032 | none listed | December 21, 2032 | patent 9901539; 21 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 Belbuca of $160.14 million in 2024, across 217,647 claims and 38,169 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 | $160.14 million | 217,647 | 38,169 | $736 |
| 2023 | $149.97 million | 198,384 | 34,521 | $756 |
| 2022 | $136.08 million | 191,709 | 33,154 | $710 |
| 2021 | $121.46 million | 187,508 | 35,680 | $648 |
| 2020 | $104.29 million | 176,630 | 35,809 | $590 |
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)
- Opioid Analgesic REMS (application NDA207932): listed as in force, with Elements to Assure Safe Use. Program dated July 9, 2012, last modified June 18, 2026. 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.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 2 designations for Buprenorphine hydrochloride. 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 |
|---|---|---|---|
| June 15, 1994 | Treatment of opiate addiction in opiate users. | Designated/Designation Withdrawn or Revoked | Indivior, Inc. |
| June 15, 1994 | Treatment of opiate addiction in opiate users. | Designated/Designation Withdrawn or Revoked | Indivior, 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 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 |
|---|---|---|---|
| KY | 371 | $256,923 | All record types |
| NV | 224 | $113,642 | Fee-for-service only |
| ME | 129 | $108,293 | All record types |
| AL | 130 | $99,022 | All record types |
| RI | 156 | $73,946 | Fee-for-service only |
| SD | 115 | $67,609 | All record types |
| MD | 60 | $62,106 | All record types |
| UT | 82 | $43,063 | All record types |
| IL | 90 | $38,550 | Fee-for-service only |
| MO | 61 | $35,950 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (5 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. 211 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 $41.89 million for Belbuca 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 | $41.89 million | 58,239 |
| 2023 | $41.12 million | 60,660 |
| 2022 | $37.37 million | 58,368 |
| 2021 | $33.27 million | 55,554 |
| 2020 | $26.72 million | 47,871 |
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
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Belbuca dated since November 11, 2025, leaving out manufacturing (CMC) changes. 2 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| June 18, 2026 | REMS | NDA207932 | 30 | FDA letter posted June 23, 2026 |
| December 22, 2025 | Labeling | NDA207932 | 29 | Label (PDF) posted January 5, 2026FDA letter posted December 29, 2025 |
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 Belbuca 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-0448-2021 | Class II | Terminated | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | 7 |
| June 2, 2021D-0449-2021 | 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 Belbuca?
The CMS negotiated-price file we read does not list Belbuca, 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 Belbuca?
No program in our finder lists this drug yet.
When could a generic version of Belbuca arrive?
For Belbuca, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA207932, December 21, 2032. 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 Belbuca?
CMS's Medicare Part D spending dataset reports gross spending on Belbuca of $160.14 million in 2024, across 217,647 claims and 38,169 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/belbuca.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.