Nicorette

(Nicotine Polacrilex Gum)

Small molecule

HHALEON

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

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

Regulatory

FDA Approval Timeline[3]

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 — 1 trial record 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]
OpenFDA — FDA approval records (NDA NDA022360). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Nicorette. U.S. Food & Drug Administration.
[5]
SEC EDGAR — HALEON company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: HHALEON

Patent Landscape[4]

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

Expected Milestones

Q2 2027

Trials by Indication[1]

Smoking1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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