Nicorette

(Nicotine Polacrilex Gum)

PreclinicalSmall molecule

HHALEON

Nicorette is one of 9 small molecule programs targeting Smoking. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

SmokingRecruiting

SmokingPreclinical

Recruiting

Competition

Competitive Landscape

10 competitors in Smoking

#DrugCompanyPhaseTrials

Nicorette

Pfizer

Approved

18 2

Wellbutrin

GGlaxo Dba Glaxosmithkline

Approved

5 3

Nicotine Free Cigarettes

Pfizer

Phase 3

5 4

Brenipatide

Eli Lilly

Phase 2

1 5

Nicotine Replacement

GSK

Preclinical

1 6

Nicotine Gum

Johnson & Johnson

Preclinical

1 7

Nicorette

HHALEON

Preclinical

1 8

Nicotine Patches

UUniversity of California, San Diego

Preclinical

2 9

Nicoderm

OOttawa Heart Institute Research Corporation

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

N/ARecruiting

Smoking

NCT07075575

Clinical

Trials by Indication[1]

Smoking1 trial

Quit-Smoking Study for Native Hawaiians

Recruiting·UUniversity of Hawaii·N/A·NCT07075575·75 enrolled

Tinnitus1 trial

A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Crossover Trial of a Single 4 mg Dose of Nicotine Polacrilex Gum on Psychoacoustic Tinnitus Loudness and Selective Attention in Non-Smoking Adults With Chronic Subjective Tinnitus

Completed·XXianhui Wang·Preclinical·NCT07772089·29 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 9, 1996

NICORETTE

NDA NDA018612

Feb 9, 1996

NICORETTE

NDA NDA020066

Oct 31, 2002

NICORETTE

NDA NDA021330

May 18, 2009

NICORETTE

NDA NDA022360

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Nicotine Polacrilex Gum. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nicotine Polacrilex Gum compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nicotine Polacrilex Gum. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022360). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Nicorette. U.S. Food & Drug Administration.
[6]
SEC EDGAR — HALEON company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: HHALEON

Patent Landscape[5]

Patent Cliff

Apr 30, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8323683Apr 30, 2028

8940772Apr 30, 2029

8501164Jun 14, 2029

Nicorette

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Smoking1 trial

Tinnitus1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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