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Two medicines, side by side

Fingolimod vs dimethyl fumarate

Fingolimod and dimethyl fumarate are both labeled for multiple sclerosis. Drugs@FDA records approvals of fingolimod since 2010 and of dimethyl fumarate since 2013. Pharmacies paid $1.58 per fingolimod 0.5 mg capsule and $0.467 per dimethyl fumarate DR 240 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.

Check it at the source: the fingolimod FDA label on DailyMed (effective July 22, 2026); the dimethyl fumarate FDA label on DailyMed (effective July 29, 2025).

Highlights of the fingolimod record

Fingolimod (Gilenya) · label of July 22, 2026

Used for

From the label: indications

GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. […]

On the market

Earliest approval on file
September 21, 2010
Generic labelers
21 labelers
Pharmacy cost
$1.58 per capsule

Supply and safety

Shortage
No current entry
Recalls
1

Highlights of the dimethyl fumarate record

Dimethyl fumarate (Tecfidera) · label of July 29, 2025

Used for

From the label: indications

Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. […]

On the market

Earliest approval on file
March 27, 2013
Generic labelers
19 labelers
Pharmacy cost
$0.467 per capsule

Supply and safety

Shortage
No current entry
Recalls
1

Source: FDA drug labels via openFDA (Fingolimod label of July 22, 2026, Dimethyl fumarate label of July 29, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do fingolimod and dimethyl fumarate differ on the record?

How each works, in its label's words: Fingolimod, “Fingolimod is metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate.”; Dimethyl fumarate, “The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown.”

Half-life, in each label's words: Fingolimod, “Elimination Fingolimod blood clearance is 6.3 ± 2.3 L/h, and the average apparent terminal half-life (t 1/2 ) is 6 to 9 …”; Dimethyl fumarate, “The terminal half-life of MMF is approximately 1 hour and no circulating MMF is present at 24 hours in the majority of …”

Generics: fingolimod since 2019; dimethyl fumarate since 2020 (Drugs@FDA).

FingolimodDimethyl fumarate
Labeled forMultiple sclerosisMultiple sclerosis
Pharmacologic classSphingosine 1-phosphate Receptor Modulatorn/a
How it works (label)Fingolimod is metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate.The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown.
Half-life (label)Elimination Fingolimod blood clearance is 6.3 ± 2.3 L/h, and the average apparent terminal half-life (t 1/2 ) is 6 to 9 days.The terminal half-life of MMF is approximately 1 hour and no circulating MMF is present at 24 hours in the majority of individuals.
Earliest approval on file (Drugs@FDA)September 21, 2010March 27, 2013
First generic approvedDecember 4, 2019August 17, 2020
Generic labelers (NDC)21 labelers19 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$1.58 per capsule (Fingolimod 0.5 mg capsule)$0.467 per capsule (Dimethyl fumarate DR 240 mg capsule)
12-month price change-72%-43%
Boxed warningNoNo
Shortage nowNo current entryNo current entry
Recalls recorded11
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)86,658122,284
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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