Is there a generic for Diroximel fumarate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Diroximel fumarate, referencing the brand VUMERITY. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diroximel fumarate?

VUMERITY (NDA 211855, BIOGEN) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Diroximel fumarate?

The Orange Book lists 3 patents against Diroximel fumarate products, with the earliest listed expiry in 2033. 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 Diroximel fumarate are approved?

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

FDA Orange Book · active-ingredient family

Diroximel fumarate

Diroximel fumarate: 1 brand, 1 generic; first approved Oct 29, 2019; generic available.

Generic available

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Sep 20, 2033

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 20, 2033

in 7 yr

Brand (NDA) products

Originator applications

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VUMERITYRLDRS
BIOGENNDA 2118552019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
231MG CAPSULE, DELAYED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
231MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Generic (ANDA) products (1)

Abbreviated applications

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DIROXIMEL FUMARATE
ZYDUSANDA 2185962025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
231MG CAPSULE, DELAYED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
231MG	CAPSULE, DELAYED RELEASE	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9090558	Sep 20, 2033	in 7 yr	U-1384
10080733	Sep 20, 2033	in 7 yr	SubstanceProductU-1384
8669281	Oct 29, 2033	in 7 yr 1 mo	SubstanceProduct

Approval history

FDA approval span

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First approval

Oct 29, 2019

7 yr 1 mo ago

Most recent approval

Nov 12, 2025

1 yr ago

Approvals span 2019–2025 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Diroximel 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.

Related FDA reference tools

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