Medicare Part D spending · FDA facts · help paying
Acthar (repository corticotropin): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Acthar of $360.06 million in 2024, across 4,926 claims and 836 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 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 |
|---|---|---|---|---|---|
| NDA008372 | Acthar | July 18, 2041 | none listed | July 18, 2041 | patent 11752199; 3 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 Acthar of $360.06 million in 2024, across 4,926 claims and 836 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 | $360.06 million | 4,926 | 836 | $73,093 |
| 2023 | $377.84 million | 5,235 | 942 | $72,176 |
| 2022 | $400.39 million | 5,913 | 1,007 | $67,713 |
| 2021 | $431.10 million | 6,667 | 1,158 | $64,661 |
| 2020 | $621.88 million | 9,857 | 1,668 | $63,091 |
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.
Medicare Part B payment limit
CMS publishes a quarterly payment limit for the HCPCS code that its NDC crosswalk links to Acthar. It is a ceiling for providers who bill Medicare Part B, not a price a patient pays, and a code's presence says nothing about whether Medicare covers a product.
| HCPCS code | Quarter | Payment limit | Per dosage descriptor | Effective | Read |
|---|---|---|---|---|---|
| J0801 | 2026 Q4 | $3,884 | 40 UNITS | October 1, 2026 through December 31, 2026 | November 7, 2026 |
Source: CMS ASP pricing files (october-2026-medicare-part-b-payment-limit-files-final.zip and the matching NDC-HCPCS crosswalk). CMS ASP pricing files page.
FDA safety program (REMS)
- H.P. Acthar Gel (application NDA008372): listed as released, without Elements to Assure Safe Use. Program dated October 15, 2010, last modified July 5, 2012. 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 spending
CMS's Medicaid spending dataset reports $40.40 million for Acthar 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 | $40.40 million | 607 |
| 2023 | $122.50 million | 1,979 |
| 2022 | $128.29 million | 2,186 |
| 2021 | $126.95 million | 2,098 |
| 2020 | $148.98 million | 2,413 |
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 Acthar dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| October 5, 2026 | Labeling | NDA008372 | 88 | Label (PDF) posted October 6, 2026FDA letter posted October 6, 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 Acthar 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 |
|---|---|---|---|---|---|
| September 2, 2026D-0803-2026 | Class II | Ongoing | Mallinckrodt Hospital Products Inc. | Presence of particulate matter: glass and stopper piece | 2 |
| February 28, 2024D-0340-2024 | Class II | Ongoing | Mallinckrodt Hospital Products Inc. | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. | 1 |
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 Acthar?
The CMS negotiated-price file we read does not list Acthar, 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 Acthar?
No program in our finder lists this drug yet.
When could a generic version of Acthar arrive?
For Acthar, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA008372, July 18, 2041. 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 Acthar?
CMS's Medicare Part D spending dataset reports gross spending on Acthar of $360.06 million in 2024, across 4,926 claims and 836 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/acthar.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; CMS ASP pricing 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.