Orange Book product · Brand (NDA)

GILENYA

FINGOLIMOD HYDROCHLORIDE

Brand (NDA)NDA 022527RX NOVARTIS

May 11, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 11, 2018
8 yr 3 mo ago
Today
Patent 9592208 expires
Listed drug product patent expiration.
Mar 30, 2032
in 5 yr 10 mo
Patent 9592208*PED expires
Listed listed patent expiration.
Sep 30, 2032
in 6 yr 5 mo

Active ingredient

FINGOLIMOD HYDROCHLORIDE

Strength

EQ 0.25MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 022527

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
9592208	Mar 30, 2032	in 5 yr 10 mo	ProductU-2315
9592208*PED	Sep 30, 2032	in 6 yr 5 mo