The short version
7 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Opfolda
miglustat · MIGLUSTAT 65 mg/1 · Capsule · Oral · Amicus Therapeutics Us, Llc
NDC 71904-0300-01 · 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC / 1 CAPSULE in 1 BOTTLE, PLASTIC · NDA · View full market →
One drug, every price
The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.
ⓘ How this was built
Data sources
- CMS NADAC (pharmacy acquisition, weekly)
- CMS Part B ASP quarterly payment limits
- CMS Maximum Fair Prices (IRA negotiated, NDC-level)
- Medicare Part D Spending by Drug (data.cms.gov, name-matched)
- VA FSS / Big4 federal contract prices (va.gov, twice monthly)
- ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
- California SB-17 WAC filings (list price, per package)
Method
Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
- Part D plans paid (avg)$33.47per dosage unitgross, before rebates — matched by drug name · 2024
- Federal ceiling (Big4)$25.01per unitAmicus Therapeutics US, LLC · Jan 1, 2026
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$142.00
Reported to Texas DSHS · 2026 annual filing · Amicus Therapeutics, US LLC
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Regulatory
- Application
- NDA215211
- TE code
- —
- Approval date
- Sep 28, 2023
- Patents / exclusivity
- 10 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NP | Sep 28, 2026 |
| patent | 12246062 | Sep 16, 2038 |
| patent | 10857212 | Aug 12, 2037 |
| patent | 11278601 | Dec 29, 2036 |
| patent | 12414985 | Dec 29, 2036 |
| patent | 11753632 | Sep 30, 2035 |
| patent | 10961522 | Sep 30, 2035 |
| patent | 10208299 | Sep 30, 2035 |
| patent | 11278599 | Mar 7, 2033 |
| patent | 12419937 | Mar 7, 2033 |
| patent | 10512677 | Mar 7, 2033 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of miglustat (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. | MIGLUSTAT 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amicus Therapeutics Us, Llc | MIGLUSTAT 65 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| ANI Pharmaceuticals, Inc. | MIGLUSTAT 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| CoTherix, Inc. | MIGLUSTAT 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Edenbridge Pharmaceuticals LLC. | MIGLUSTAT 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Navinta LLC | MIGLUSTAT 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | MIGLUSTAT 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Opfolda — NDC 71904-0300-01," retrieved September 3, 2026, https://drugdashboards.com/drug/71904030001.
Free to cite with attribution — see how the data is put together.