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Last Updated: October 27, 2021

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Nicotine - Generic Drug Details

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What are the generic sources for nicotine and what is the scope of freedom to operate?

Nicotine is the generic ingredient in nine branded drugs marketed by Dr Reddys Labs Sa, Sanofi Aventis Us, Aveva, Mcneil Cons, Pfizer, Pfizer Inc, Glaxosmithkline, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Glaxosmithkline Cons, Aurobindo Pharma Ltd, and Pld Acquisitions, and is included in sixty NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nicotine has thirty patent family members in twenty-three countries.

There are thirty drug master file entries for nicotine. Twenty-four suppliers are listed for this compound.

Drug Prices for nicotine

See drug prices for nicotine

Drug Sales Revenue Trends for nicotine

See drug sales revenues for nicotine

Recent Clinical Trials for nicotine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of PennsylvaniaPhase 2/Phase 3
AIDS Malignancy ConsortiumN/A
National Cancer Institute, FranceN/A

See all nicotine clinical trials

Pharmacology for nicotine
Medical Subject Heading (MeSH) Categories for nicotine
Paragraph IV (Patent) Challenges for NICOTINE
Tradename Dosage Ingredient NDA Submissiondate
NICODERM CQ FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020165 2014-05-30
HABITROL FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020076

US Patents and Regulatory Information for nicotine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 206394-001 Dec 15, 2016 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 074707-001 Mar 19, 1999 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078697-001 Dec 29, 2008 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 090821-002 Jul 10, 2009 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 079216-001 Jul 8, 2009 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-006 Nov 12, 1999 OTC Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Ivax Sub Teva Pharms NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 076880-001 Feb 18, 2009 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nicotine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-003 Dec 23, 1998 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-004 Nov 12, 1999 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Moodys
Dow

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