Orange Book product · Brand (NDA)

GILENYA

FINGOLIMOD HYDROCHLORIDE

Brand (NDA)NDA 022527TE ABRX NOVARTIS

Sep 21, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 21, 2010
16 yr ago
Today
Patent 10543179 expires
Listed method-of-use patent (U-2719) expiration.
Dec 25, 2027
in 1 yr 6 mo

Active ingredient

FINGOLIMOD HYDROCHLORIDE

Strength

EQ 0.5MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 022527

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
10543179	Dec 25, 2027	in 1 yr 6 mo	U-2719