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NICOTROL

NDA

NICOTINE | N020714 | PFIZER INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

363 trials from ClinicalTrials.gov — 36 recruiting, 16 active, 270 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Smartphone-delivered Scheduled Smoking With Compliance Facilitation as an Adjunct Cessation Therapy: a Feasibility Study NCT05763771	N/A	Active	M.D. Anderson Cancer Center	56	2024-02-15 → 2027-12-01
Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer NCT05144542	N/A	Active	M.D. Anderson Cancer Center	135	2022-03-07 → 2026-10-17
Electronic Cigarettes and Reactivity to Smoking Cues NCT01782599	N/A	Active	Mclean Hospital	125	2013-01 → 2027-03-24
Physical Activity in Promoting Smoking Cessation in African Americans NCT01915810	N/A	Active	M.D. Anderson Cancer Center	45	2014-01-29 → 2027-01-31
Nicotine Pouch Pharmacokinetics Abuse Liability NCT07476144	Phase 1	Active	JT International SA	55	2026-01-08 → 2026-10
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer NCT03059940	Early Phase 1	Active	M.D. Anderson Cancer Center	630	2017-06-16 → 2026-06-01
Smoking Cessation for Depressed Smokers NCT00494728	Phase 1/2	Active	M.D. Anderson Cancer Center	91	2007-06-28 → 2028-06-30
Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation NCT02697227	N/A	Active	M.D. Anderson Cancer Center	85	2016-08-05 → 2027-12-31
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1)NCT06822049	Phase 2/3	Active	State University of New York at Buffalo	200	2025-03-10 → 2027-02-28
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)NCT04200534	Early Phase 1	Active	M.D. Anderson Cancer Center	358	2020-07-31 → 2027-02-28

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain15 active DMFs8 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED LTDNICOTINE

DMF 77661988

NICOBRAND LTDNICOTINE

DMF 78841989

SIEGFRIED LTDNICOTINE BITARTRATE DIHYDRATE

DMF 172212004

CAMBREX CHARLES CITY INCNICOTINE RESINATE, 20%

DMF 217562008

BGP HEALTHCARE PRIVATE LTDNICOTINE USP

DMF 234852010

PORTON FINE CHEMICALS LTDNICOTINE USP

DMF 265412012

KENVUE BRANDS LLCNICOTINE OROMUCOSAL SPRAY

DMF 292362015

NICO ORGO MARKETING PVT LTDNICOTINE USP

DMF 351622021

ZANOPRIMA LIFESCIENCES LTDNICOTINE USP (SYNTHETIC)

DMF 372232022

PORTON PHARMA SOLUTIONS LTDNICOTINE (SYNTHETIC)

DMF 380202023

ALCHEM INTERNATIONAL PRIVATE LTDNICOTINE USP (4691A)

DMF 383192023

QUAD LIFESCIENCES PVT LTDNICOTINE USP

DMF 395292024

INDIA GLYCOLS LTDNICOTINE USP

DMF 415312025

WUHAN RS PHARMACEUTICALS CO LTDNICOTINE

DMF 421592025

NICO ORGO MARKETING PVT LTDNICOTINE POLACRILLEX USP

DMF 423792025

MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC INCInactiveNICOTINE RESIN COMPLEX 20%

DMF 57571985

SIGMA F AND D DIV LTDInactiveNICOTINE #3876 FD

DMF 74461988

PHARMACIA AND UPJOHNInactiveNICOTINE TRANSDERMAL DELIVERY SYSTEM

DMF 77461988

TAMAG BASEL AGInactiveNICOTINE

DMF 79361989

PHARMACIA AND UPJOHNInactiveNICOTINE INHALER

DMF 86521990

NICOBRAND LTDInactiveNICOTINE BITARTRATE DIHYDRATE

DMF 125841997

MCNEIL CONSUMER HEALTHCAREInactiveNICOTINE PURIFICATION PROCESS

DMF 130151998

DIXIE CHEMICAL CO INCInactiveNICOTINE USP AND NICOTINE USP-HP

DMF 214722008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
May 24, 2024	SUPPL -19	View Letter (PDF)
Sep 3, 2019	SUPPL -18	View Letter (PDF)
Jul 8, 2009	SUPPL -16	View Letter (PDF)
Jul 21, 2004	SUPPL -12	View Letter (PDF)
Nov 25, 2003	SUPPL -11	View Letter (PDF)
Sep 8, 2002	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG/CARTRIDGE

RLD

0 patents0 exclusivities▴

INHALANT;ORAL | Approved: May 2, 1997

No patent or exclusivity listings for this strength.