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FDA Orange Book · active-ingredient family

Nicotine polacrilex

Nicotine polacrilex is approved as 4 brand and 52 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NICORETTE · NDA 022360

4

Brand (NDA)

52

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · gum, chewing, troche/lozenge

ProductApplicantApplicationTEApproved
NICORETTERLD×2HALEON US HOLDINGSNDA 022360—May 18, 2009
NICORETTERLD×2HALEON US HOLDINGSNDA 021330—Oct 31, 2002
NICORETTERLD×3HALEON US HOLDINGSNDA 018612—Feb 09, 1996
NICORETTERLD×3HALEON US HOLDINGSNDA 020066—Feb 09, 1996

Generic (ANDA) products (52)

ProductApplicantApplicationTEApproved
NICOTINE POLACRILEX×2DR REDDYS LABS SAANDA 215276—Jul 17, 2025
NICOTINE POLACRILEXFERTIN PHARMAANDA 214354—Dec 21, 2022
NICOTINE POLACRILEX×2AUROBINDO PHARMA LTDANDA 215357—May 13, 2022
NICOTINE POLACRILEX×2AUROBINDO PHARMAANDA 213266—Aug 03, 2021
NICOTINE POLACRILEX×2DR REDDYS LABS SAANDA 213233—Aug 04, 2020
NICOTINE POLACRILEX×2P AND LANDA 212057—May 14, 2020
NICOTINE POLACRILEX×2DR REDDYS LABS SAANDA 212983—Feb 21, 2020
NICOTINE POLACRILEX×2DR REDDYS LABS SAANDA 212796—Jan 08, 2020
NICOTINE POLACRILEX×2P AND LANDA 208875—Oct 31, 2019
NICOTINE POLACRILEX×2P AND LANDA 209520—Oct 31, 2019
NICOTINE POLACRILEX×2P AND LANDA 210711—Oct 31, 2019
NICOTINE POLACRILEX×2P AND LANDA 210712—Sep 06, 2019
NICOTINE POLACRILEX×2P AND LANDA 212056—Jul 26, 2019
NICOTINE POLACRILEX×2PLD ACQUISITIONSANDA 207868—Feb 07, 2019
NICOTINE POLACRILEX×2P AND LANDA 209519—Jul 02, 2018
NICOTINE POLACRILEX×2P AND LANDA 209206—Jun 26, 2018
NICOTINE POLACRILEXPERRIGO R AND DANDA 206394—Dec 15, 2016
NICOTINE POLACRILEXPERRIGO R AND DANDA 206393—Dec 15, 2016
NICOTINE POLACRILEXP AND LANDA 204794—May 10, 2016
NICOTINE POLACRILEXP AND LANDA 204833—Feb 26, 2016
NICOTINE POLACRILEX×2PPI-DACANDA 203690—Oct 09, 2012
NICOTINE POLACRILEXPERRIGO R AND DANDA 091349—Jul 20, 2011
NICOTINE POLACRILEXPERRIGO R AND DANDA 091354—Jul 20, 2011
NICOTINE POLACRILEX×2PERRIGO R AND DANDA 090821—Jul 10, 2009
NICOTINE POLACRILEX×2PPI-DACANDA 090711—Jul 10, 2009
NICOTINE POLACRILEXP AND LANDA 079044—Jul 08, 2009
NICOTINE POLACRILEXP AND LANDA 079216—Jul 08, 2009
NICOTINE POLACRILEXP AND LANDA 079038—Jul 08, 2009
NICOTINE POLACRILEXP AND LANDA 079219—Jul 08, 2009
NICOTINE POLACRILEXIVAX SUB TEVA PHARMSANDA 076880—Feb 18, 2009
NICOTINE POLACRILEXIVAX SUB TEVA PHARMSANDA 077850—Feb 18, 2009
NICOTINE POLACRILEXP AND LANDA 078699—Dec 29, 2008
NICOTINE POLACRILEXP AND LANDA 078697—Dec 29, 2008
NICOTINE POLACRILEXPERRIGO R AND DANDA 078967—Apr 23, 2008
NICOTINE POLACRILEXPERRIGO R AND DANDA 078968—Apr 23, 2008
THRIVEGLAXOSMITHKLINE CONSANDA 077658—Jun 19, 2007
THRIVEGLAXOSMITHKLINE CONSANDA 077656—Jun 19, 2007
NICOTINE POLACRILEXPERRIGO R AND DANDA 078547—May 24, 2007
NICOTINE POLACRILEXPERRIGO R AND DANDA 078546—May 24, 2007
NICOTINE POLACRILEXPERRIGO R AND DANDA 078325—Oct 30, 2006
NICOTINE POLACRILEXPERRIGO R AND DANDA 078326—Oct 30, 2006
NICOTINE POLACRILEX×2PERRIGO R AND DANDA 077007—Jan 31, 2006
NICOTINE POLACRILEXL PERRIGO COANDA 076775—Sep 16, 2004
NICOTINE POLACRILEXL PERRIGO COANDA 076776—Sep 16, 2004
NICOTINE POLACRILEXL PERRIGO COANDA 076777—Sep 16, 2004
NICOTINE POLACRILEXL PERRIGO COANDA 076778—Sep 16, 2004
NICOTINE POLACRILEXL PERRIGO COANDA 076779—Sep 16, 2004
NICOTINE POLACRILEXL PERRIGO COANDA 076789—Sep 16, 2004
NICOTINE POLACRILEXP AND LANDA 076569—Jul 29, 2004
NICOTINE POLACRILEXP AND LANDA 076568—Jul 29, 2004
NICOTINE POLACRILEXP AND LANDA 074707—Mar 19, 1999
NICOTINE POLACRILEXP AND LANDA 074507—Mar 15, 1999

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8323683Apr 30, 2028in 1 yr 11 mo
8940772Apr 30, 2029in 2 yr 11 mo
Product
8501164Jun 14, 2029in 3 yr
Product

Nicotine polacrilex — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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