Orange Book product · Brand (NDA)

MAVENCLAD

CLADRIBINE

Brand (NDA)NDA 022561TE ABRX EMD SERONO INC

Mar 29, 2019

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 29, 2019
7 yr 4 mo ago
Today
Patent 10849919 expires
Listed method-of-use patent (U-3411) expiration.
Nov 23, 2038
in 12 yr 7 mo
Patent 12533408 expires
Listed method-of-use patent (U-4395) expiration.
Sep 10, 2041
in 15 yr 5 mo
Patent 12539329 expires
Listed method-of-use patent (U-4399) expiration.
Sep 10, 2041
in 15 yr 5 mo

Active ingredient

CLADRIBINE

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022561

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
10849919	Nov 23, 2038	in 12 yr 7 mo	U-3411
12533408	Sep 10, 2041	in 15 yr 5 mo	U-4395
12539329	Sep 10, 2041	in 15 yr 5 mo	U-4399