Is there a generic for Dimethyl fumarate?

Yes. The FDA Orange Book lists 17 approved generic (ANDA) applications for Dimethyl fumarate, referencing the brand TECFIDERA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dimethyl fumarate?

TECFIDERA (NDA 204063, BIOGEN) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Dimethyl fumarate?

The Orange Book lists 9 patents against Dimethyl fumarate products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Dimethyl fumarate are approved?

Dimethyl fumarate is approved in the following dosage form: capsule, delayed release.

FDA Orange Book · active-ingredient family

Dimethyl fumarate

Dimethyl fumarate: 1 brand, 17 generics; first approved Mar 27, 2013; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 17 ANDA applications approved.

Earliest patent expiry Feb 07, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 07, 2028

in 1 yr 6 mo

Brand (NDA) products

Originator applications

TECFIDERARLD
BIOGENNDA 20406320132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Generic (ANDA) products (17)

Abbreviated applications

DIMETHYL FUMARATE
TORRENTANDA 21039020252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
240MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
DIMETHYL FUMARATE
MACLEODS PHARMS LTDANDA 21037720242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
AUROBINDO PHARMAANDA 21038520222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
PRINSTON INCANDA 21041420222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
SAWAI USAANDA 21028520212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
240MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
DIMETHYL FUMARATE
SOLA PHARMSANDA 21043620212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
TWI PHARMSANDA 21038220202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
GLENMARK PHARMS LTDANDA 21030920202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
LUPINANDA 21022620202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
ACCORD HLTHCAREANDA 21049920202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
ALKEM LABS LTDANDA 21044020202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
AMNEALANDA 21040220202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
CIPLAANDA 21030520202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
240MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
DIMETHYL FUMARATE
HETERO LABS LTD IIIANDA 21050020202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
MSNANDA 21046020202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Rx AB
240MG CAPSULE, DELAYED RELEASE ORAL Rx AB
DIMETHYL FUMARATE
ZYDUS PHARMSANDA 21053820202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
240MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
DIMETHYL FUMARATE
MYLANANDA 21053120202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
120MG CAPSULE, DELAYED RELEASE ORAL Discontinued —
240MG CAPSULE, DELAYED RELEASE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—
240MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—
240MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—
240MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB
240MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—
240MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
120MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—
240MG	CAPSULE, DELAYED RELEASE	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8399514	Feb 07, 2028	in 1 yr 6 mo	U-1384
10391160	Mar 13, 2035	in 8 yr 9 mo	U-3148
10555993	Mar 13, 2035	in 8 yr 9 mo	U-3148
10994003	Mar 13, 2035	in 8 yr 9 mo	U-3148
10959972	Nov 16, 2035	in 9 yr 5 mo	U-1384
11129806	Nov 16, 2035	in 9 yr 5 mo	U-1384
11007166	Nov 16, 2035	in 9 yr 5 mo	U-1384
11007167	Nov 16, 2035	in 9 yr 5 mo	U-1384
11246850	Nov 16, 2035	in 9 yr 5 mo	U-1384

Approval history

FDA approval span

First approval

Mar 27, 2013

13 yr 7 mo ago

Most recent approval

Jan 06, 2025

1 yr 7 mo ago

Approvals span 2013–2025 across 18 FDA applications.

Brand (NDA) 16%

Generic (ANDA) 1794%

Dimethyl fumarate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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