Question 1

Is there a generic for Diroximel fumarate?

Accepted Answer

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.

Question 2

What is the reference-listed drug for Diroximel fumarate?

Accepted Answer

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

Question 3

What patents protect Diroximel fumarate?

Accepted Answer

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.

Question 4

What dosage forms of Diroximel fumarate are approved?

Accepted Answer

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

Patent	Expires	In	Type
9090558	Sep 20, 2033	in 7 yr 4 mo	U-1384
10080733	Sep 20, 2033	in 7 yr 4 mo	SubstanceProductU-1384
8669281	Oct 29, 2033	in 7 yr 6 mo	SubstanceProduct

Diroximel fumarate

Brand (NDA) products · capsule, delayed release

Generic (ANDA) products (1)

Listed patents (3)

Diroximel fumarate — frequently asked questions

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