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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nicotrol (2023)

Total Spending

$15.3M

Total Claims

25,534

Beneficiaries

14,410

Avg Cost/Unit

$3.18

Spending Trend

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

YoY Change:+5.9%

5yr CAGR:+5.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain16 active DMFs8 inactive

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

SIEGFRIED LTDNICOTINE

DMF 77661988

NICOBRAND LTDNICOTINE

DMF 78841989

CAMBREX CHARLES CITY INCNICOTINE POLACRILEX, 15%, USP

DMF 161662002

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.