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NICORETTE

NDA

NICOTINE POLACRILEX | N021330 | HALEON US HOLDINGS LLC

2 strengths0 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

API Supply Chain9 active DMFs4 inactive

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

NICOBRAND LTDNICOTINE POLACRILEX RESIN

DMF 107391994

LABORATORIOS HAYMANN SANICOTINE POLACRILEX USP , 20%

DMF 169102003

FERTIN PHARMA ASNICOTINE POLACRILEX USP

DMF 201232007

SIEGFRIED LTDNICOTINE POLACRILEX 20%

DMF 221552008

BGP HEALTHCARE PRIVATE LTDNICOTINE POLACRILEX 20% USP

DMF 238382010

KENVUE BRANDS LLCNICOTINE POLACRILEX LOZENGE

DMF 322002018

FERTIN PHARMA ASNICOTINE POLACRILEX USP

DMF 356472021

NICOBRAND LTDNICOTINE POLACRILEX 20%

DMF 384412024

INDIA GLYCOLS LTDNICOTINE POLACRILEX USP

DMF 398692024

WYCKOFF CHEMICAL CO INCInactiveNICOTINE POLACRILEX

DMF 76541988

FINE CHEMICALS CORPInactiveNICOTINE POLACRILEX

DMF 105271993

SALSBURY CHEMICALS INCInactiveNICOTINE POLACRILEX RESIN

DMF 141931999

SMS PHARMACEUTICALS LTDInactiveNICOTINE POLACRILEX USP

DMF 219782008

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

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Sep 9, 2024	SUPPL -26	View Letter (PDF)
Nov 10, 2021	SUPPL -24	View Letter (PDF)
May 22, 2019	SUPPL -21	View Letter (PDF)
Oct 2, 2015	SUPPL -19	View Letter (PDF)
Aug 10, 2015	SUPPL -20	View Letter (PDF)
May 20, 2015	SUPPL -18	View Letter (PDF)
Aug 15, 2014	SUPPL -17	View Letter (PDF)
Oct 29, 2013	SUPPL -16	View Letter (PDF)
Aug 8, 2013	SUPPL -15	View Letter (PDF)
May 29, 2012	SUPPL -13	View Letter (PDF)
Aug 31, 2010	SUPPL -9	View Letter (PDF)
Jan 15, 2010	SUPPL -8	View Letter (PDF)
May 28, 2008	SUPPL -7	View Letter (PDF)
Sep 18, 2006	SUPPL -5	View Letter (PDF)
Nov 30, 2005	SUPPL -4	View Letter (PDF)
Nov 1, 2005	SUPPL -3	View Letter (PDF)
Feb 27, 2004	SUPPL -2	View Letter (PDF)
Oct 31, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2MG BASE

RLD

0 patents0 exclusivities▴

TROCHE/LOZENGE;ORAL | Approved: Oct 31, 2002

No patent or exclusivity listings for this strength.

#002 — EQ 4MG BASE

RLD

0 patents0 exclusivities▾

TROCHE/LOZENGE;ORAL | Approved: Oct 31, 2002