DrugDashboards

Dimethyl Fumarate

Dimethyl Fumarate · DIMETHYL FUMARATE 240 mg/1 · Capsule, Delayed Release · Oral · SOLA Pharmaceuticals, LLC

NDC 70512-0853-60 · 1 BOTTLE in 1 CARTON / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

18 companies supply this market — deep enough that no single failure threatens the supply. The price has fallen 47% in a year, to $0.4500 per unit — and generics that get this cheap tend to get abandoned rather than defended. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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.

  • Pharmacies pay (NADAC)$0.4500per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$15.97per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$1.23per unitSola Pharmaceuticals, LLC. DBA Sola Pharmaceuticals · Apr 12, 2024273% of what pharmacies pay — higher than 81% of drugs with this benchmark
  • Medicaid generic ceiling (FUL)$0.4500per CAPweighted avg manufacturer price $0.2376 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 24979-0128-04) — 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ⓘ
$2.00per unit
middle half $1.47–$7.26 · 4,096 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $2.00
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
75%of plans cover it
tier 4 · prior auth 69% · step therapy 0% · qty limit 95%

*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 4 quarters since 2024.

NADAC price per unit

$0$5.00$10.00$15.00Dec 2023Sep 2026$0.45
34 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$13.50
#90 count
$40.50

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$699
11 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

15● Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • price down 48% year over year+15

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for dimethyl fumarate (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

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
ANDA210436
TE code
AB
Approval date
Mar 26, 2021
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 (Capsule, Delayed Release)

LabelerStrengthFirst seenLast seen
Golden State Medical Supply, Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 3, 2026
Golden State Medical Supply, Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Msn Laboratories Private LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Msn Laboratories Private LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
SOLA Pharmaceuticals, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
SOLA Pharmaceuticals, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare US, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare US, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Dimethyl Fumarate — NDC 70512-0853-60," retrieved September 3, 2026, https://drugdashboards.com/drug/70512085360.

Free to cite with attribution — see how the data is put together.