Orange Book product · Brand (NDA)

VUMERITY

DIROXIMEL FUMARATE

Brand (NDA)NDA 211855TE ABRX BIOGEN

Oct 29, 2019

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 29, 2019
6 yr 9 mo ago
Today
Patent 10080733 expires
Listed drug substance patent expiration.
Sep 20, 2033
in 7 yr 4 mo
Patent 9090558 expires
Listed method-of-use patent (U-1384) expiration.
Sep 20, 2033
in 7 yr 4 mo
Patent 8669281 expires
Listed drug substance patent expiration.
Oct 29, 2033
in 7 yr 6 mo

Active ingredient

DIROXIMEL FUMARATE

Strength

231MG

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

Application

NDA 211855

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10080733	Sep 20, 2033	in 7 yr 4 mo	SubstanceProductU-1384
9090558	Sep 20, 2033	in 7 yr 4 mo	U-1384
8669281	Oct 29, 2033	in 7 yr 6 mo	SubstanceProduct