Orange Book product · Brand (NDA)

VIZIMPRO

DACOMITINIB

Brand (NDA)NDA 211288RX PFIZER

Sep 27, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 27, 2018
7 yr 10 mo ago
Patent 10596162 expires
Listed method-of-use patent (U-3338) expiration.
Feb 02, 2026
5 mo ago
Patent 10603314 expires
Listed method-of-use patent (U-3337) expiration.
Feb 02, 2026
5 mo ago
Today
Patent 7772243 expires
Listed drug substance patent expiration.
Sep 27, 2032
in 6 yr 4 mo

Active ingredient

DACOMITINIB

Strength

15MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 211288

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
10596162	Feb 02, 2026	5 mo ago	U-3338
10603314	Feb 02, 2026	5 mo ago	U-3337
7772243	Sep 27, 2032	in 6 yr 4 mo	SubstanceProduct