Orange Book product · Brand (NDA)

TASCENSO ODT

FINGOLIMOD LAURYL SULFATE

Brand (NDA)NDA 214962RX CYCLE

Dec 23, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 23, 2021
4 yr 7 mo ago
Today
Patent 10555902 expires
Listed method-of-use patent (U-3268) expiration.
Jan 19, 2036
in 9 yr 9 mo
Patent 10925829 expires
Listed drug product patent expiration.
Jan 19, 2036
in 9 yr 9 mo
Patent 9925138 expires
Listed drug product patent expiration.
Jan 19, 2036
in 9 yr 9 mo

Active ingredient

FINGOLIMOD LAURYL SULFATE

Strength

EQ 0.25MG BASE

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

NDA 214962

Product number

001

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
10555902	Jan 19, 2036	in 9 yr 9 mo	U-3268
10925829	Jan 19, 2036	in 9 yr 9 mo	Product
9925138	Jan 19, 2036	in 9 yr 9 mo	Product