Medicare Part D spending · FDA facts · help paying
Skyclarys (omaveloxolone): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Skyclarys of $101.27 million in 2024, across 3,241 claims and 380 beneficiaries. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file.
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 |
|---|---|---|---|---|---|
| NDA216718 | Skyclarys | April 24, 2033 | February 28, 2030 | April 24, 2033 | patent 8993640; 10 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 Skyclarys of $101.27 million in 2024, across 3,241 claims and 380 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 | $101.27 million | 3,241 | 380 | $31,247 |
| 2023 | $45.00 million | 1,428 | 321 | $31,510 |
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 omaveloxolone, 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 |
|---|---|---|---|
| September 5, 2017 | Treatment of stage IIb through IV malignant melanoma | Designated/Designation Withdrawn or Revoked | Reata Pharmaceuticals, Inc. |
| June 19, 2017 | Treatment of Friedreich's Ataxia | Designated/Approved | Biogen U.S. Corporation |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid spending
CMS's Medicaid spending dataset reports $74.40 million for Skyclarys 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 | $74.40 million | 2,477 |
| 2023 | $23.41 million | 777 |
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
VA national formulary
The VA's national formulary files list the ingredient omaveloxolone, which covers every maker's product with that ingredient, not only Skyclarys. Each row is a VA national drug file entry and its status.
| VA entry | Status | Active NDCs |
|---|---|---|
| OMAVELOXOLONE CAP,ORAL | Non-formulary | 1 |
Source: VA Pharmacy Benefits Management national formulary (va-formulary-2026-09), read November 7, 2026. VA 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 Skyclarys dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| April 7, 2026 | Labeling | NDA216718 | 14 | Label (PDF) posted April 10, 2026FDA letter posted April 9, 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.
Questions
Does Medicare have a negotiated price for Skyclarys?
The CMS negotiated-price file we read does not list Skyclarys, 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 Skyclarys?
No program in our finder lists this drug yet.
When could a generic version of Skyclarys arrive?
For Skyclarys, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA216718, April 24, 2033. 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 Skyclarys?
CMS's Medicare Part D spending dataset reports gross spending on Skyclarys of $101.27 million in 2024, across 3,241 claims and 380 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/skyclarys.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. 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.