Medicare Part D spending · FDA facts · help paying
Copaxone (glatiramer acetate): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Copaxone of $257.16 million in 2024, across 40,460 claims and 4,785 beneficiaries. 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 5 recall entries.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Copaxone of $257.16 million in 2024, across 40,460 claims and 4,785 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 | $257.16 million | 40,460 | 4,785 | $6,356 |
| 2023 | $369.37 million | 54,312 | 6,385 | $6,801 |
| 2022 | $456.60 million | 67,063 | 7,923 | $6,808 |
| 2021 | $556.47 million | 82,866 | 9,680 | $6,715 |
| 2020 | $713.59 million | 107,923 | 12,092 | $6,612 |
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 2 designations for glatiramer acetate, 1 with an approval recorded. 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 |
|---|---|---|---|
| November 14, 2007 | Treatment of amyotrophic lateral sclerosis (ALS). | Designated | Teva Neurosciences, Inc. |
| November 9, 1987 | Treatment of multiple sclerosis | Designated/Approved | Teva Pharmaceuticals USA |
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 |
|---|---|---|---|
| UT | 52 | $302,929 | 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. 45 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.
FDA drug safety communication
The most recent FDA Drug Safety Communication that names glatiramer acetate is dated January 22, 2025: FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa). It is the FDA's own dated notice, listed as published. OmniRx does not interpret it or say whether it applies to your treatment.
Source: FDA Drug Safety Communications, read November 7, 2026.
Medicaid spending
CMS's Medicaid spending dataset reports $54.23 million for Copaxone 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 | $54.23 million | 9,206 |
| 2023 | $67.53 million | 11,611 |
| 2022 | $78.74 million | 13,301 |
| 2021 | $93.99 million | 15,755 |
| 2020 | $98.11 million | 16,864 |
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 Copaxone dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| June 22, 2026 | Labeling | NDA020622 | 121 | Label (PDF) posted June 23, 2026FDA letter posted July 2, 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 Copaxone 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 |
|---|---|---|---|---|---|
| May 16, 2018D-0765-2018 | Class II | Terminated | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. | 1 |
| May 16, 2018D-0766-2018 | Class II | Terminated | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. | 1 |
| November 27, 2013D-001-2014 | Class II | Terminated | Teva Pharmaceuticals USA | Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. | 3 |
| April 24, 2013D-249-2013 | Class II | Terminated | Teva Pharmaceuticals USA, Inc. | Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system. | 3 |
| August 15, 2012D-1442-2012 | Class II | Terminated | Teva Pharmaceuticals USA, Inc. | Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. | 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 Copaxone?
The CMS negotiated-price file we read does not list Copaxone, 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 Copaxone?
No program in our finder lists this drug yet.
How much does Medicare Part D spend on Copaxone?
CMS's Medicare Part D spending dataset reports gross spending on Copaxone of $257.16 million in 2024, across 40,460 claims and 4,785 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/copaxone.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.