Orange Book product · Brand (NDA)

CERDELGA

ELIGLUSTAT TARTRATE

Brand (NDA)NDA 205494TE ABRX GENZYME CORP

Aug 19, 2014

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 19, 2014
12 yr ago
Today
Patent 7196205 expires
Listed drug substance patent expiration.
Jun 26, 2026
in 7 d
Patent 11458119 expires
Listed drug substance patent expiration.
Nov 24, 2030
in 4 yr 6 mo
Patent 10888547 expires
Listed method-of-use patent (U-3042) expiration.
Jan 31, 2031
in 4 yr 8 mo
Patent 10888547 expires
Listed method-of-use patent (U-3043) expiration.
Jan 31, 2031
in 4 yr 8 mo
Patent 12465586 expires
Listed method-of-use patent (U-3042) expiration.
Jun 05, 2032
in 6 yr 1 mo
Patent 12465586 expires
Listed method-of-use patent (U-3043) expiration.
Jun 05, 2032
in 6 yr 1 mo
Patent 10888544 expires
Listed method-of-use patent (U-3041) expiration.
Dec 13, 2038
in 12 yr 8 mo
Patent 10888544 expires
Listed method-of-use patent (U-3040) expiration.
Dec 13, 2038
in 12 yr 8 mo

Active ingredient

ELIGLUSTAT TARTRATE

Strength

EQ 84MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 205494

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
7196205	Jun 26, 2026	in 7 d	Substance
11458119	Nov 24, 2030	in 4 yr 6 mo	SubstanceProduct
10888547	Jan 31, 2031	in 4 yr 8 mo	U-3042
10888547	Jan 31, 2031	in 4 yr 8 mo	U-3043
12465586	Jun 05, 2032	in 6 yr 1 mo	U-3042
12465586	Jun 05, 2032	in 6 yr 1 mo	U-3043
10888544	Dec 13, 2038	in 12 yr 8 mo	U-3041
10888544	Dec 13, 2038	in 12 yr 8 mo	U-3040