Orange Book product · Brand (NDA)

TYKERB

LAPATINIB DITOSYLATE

Brand (NDA)NDA 022059TE ABRX NOVARTIS

Mar 13, 2007

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 13, 2007
19 yr 7 mo ago
Today
Patent 8821927 expires
Listed drug substance patent expiration.
Sep 18, 2029
in 3 yr 4 mo

Active ingredient

LAPATINIB DITOSYLATE

Strength

EQ 250MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022059

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
8821927	Sep 18, 2029	in 3 yr 4 mo	SubstanceProduct