Orange Book product · Brand (NDA)

NICORETTE

NICOTINE POLACRILEX

Brand (NDA)NDA 022360OTC HALEON US HOLDINGS

May 18, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 18, 2009
17 yr 4 mo ago
Today
Patent 8940772 expires
Listed drug product patent expiration.
Apr 30, 2029
in 2 yr 11 mo
Patent 8501164 expires
Listed drug product patent expiration.
Jun 14, 2029
in 3 yr

Active ingredient

NICOTINE POLACRILEX

Strength

EQ 2MG BASE

Dosage form

TROCHE/LOZENGE

Route

ORAL

TE code

Not listed

Application

NDA 022360

Product number

001

Marketing status

OTC

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
8940772	Apr 30, 2029	in 2 yr 11 mo	Product
8501164	Jun 14, 2029	in 3 yr	Product