Viewing data from:

NICOTROL

NDA

NICOTINE | N020385 | 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

308 trials from ClinicalTrials.gov — 1 recruiting, 10 active, 256 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction NCT03442413	Phase 1	Active	University of Pennsylvania	13	2018-06-28 → 2026-11-22
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
Randomized Trial of Electronic Cigarettes With or Without Nicotine in Smoking Cessation.NCT03630614	Phase 3	Active	Assistance Publique - Hôpitaux de Paris	650	2018-10-17 → 2029-12
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites NCT03315910	Phase 4	Active	Memorial Sloan Kettering Cancer Center	807	2017-10-10 → 2026-10
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
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
Optimizing Tobacco Use Treatment for PLWHA NCT04176172	Phase 3	Active	University of Pennsylvania	340	2020-02-17 → 2026-11-30
Reward Sensitivity and Pharmacotherapy for Smoking Cessation NCT02162849	Phase 4	Active	M.D. Anderson Cancer Center	204	2015-12-14 → 2028-02-28
Smoking Cessation for Depressed Smokers NCT00494728	Phase 1/2	Active	M.D. Anderson Cancer Center	91	2007-06-28 → 2028-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$12.96

per ml

Lowest NADAC/Unit

$12.96

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009540101NICOTROL NS 10 MG/ML SPRAY	$12.96	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$405.49

Highest Price

$539.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00009-5401-01NICOTROL NS 10MG/ML NASAL SPRAY	$539.62	FSS	Pfizer Inc.	06/30/2029
00009-5401-01NICOTROL NS 10MG/ML NASAL SPRAY	$405.49	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Nicotrol (2024)

Total Spending

$740K

Total Claims

1,297

Beneficiaries

824

Avg Cost/Unit

$2.94

Spending Trend

$15.8M(2019)→$15.6M(2020)→$17.8M(2021)→$18.6M(2022)→$15.3M(2023)→$740K(2024)

YoY Change:-7.5%

5yr CAGR:+2.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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 -12	View Letter (PDF)
Sep 3, 2019	SUPPL -11	View Letter (PDF)
Jul 1, 2010	SUPPL -10	View Letter (PDF)
Jul 21, 2004	SUPPL -7	View Letter (PDF)
Nov 25, 2003	SUPPL -6	View Letter (PDF)
Sep 8, 2002	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG/SPRAY

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Mar 22, 1996

No patent or exclusivity listings for this strength.