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.
Dimethyl Fumarate
Dimethyl Fumarate · Kit · Cipla USA Inc.
NDC 69097-0552-03 · 1 KIT in 1 KIT * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 64406-0007-03) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$174.33per unit
middle half $174.33–$174.33 · 17 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $174.33
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 5 · prior auth 12% · step therapy 0% · qty limit 100%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
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
$112.50
Reported to Texas DSHS · 2025 annual filing · Cipla USA Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · manufacture
- analysis · api manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $1,141.99 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA210305
- TE code
- —
- Approval date
- Sep 24, 2020
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Dimethyl Fumarate (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Macleods Pharmaceuticals Limited | Jul 15, 2026 | Sep 3, 2026 | |
| Amneal Pharmaceuticals NY LLC | Jul 15, 2026 | Sep 2, 2026 | |
| Ascend Laboratories, LLC | Jul 15, 2026 | Sep 2, 2026 | |
| Biogen Inc. | Jul 15, 2026 | Sep 2, 2026 | |
| Camber Pharmaceuticals, Inc. | Jul 15, 2026 | Sep 2, 2026 | |
| Cipla USA Inc. | Jul 15, 2026 | Sep 2, 2026 | |
| Msn Laboratories Private Limited | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Dimethyl Fumarate — NDC 69097-0552-03," retrieved September 3, 2026, https://drugdashboards.com/drug/69097055203.
Free to cite with attribution — see how the data is put together.