Nicotine - Generic Drug Details

What are the generic sources for nicotine and what is the scope of patent protection?

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

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

Summary for nicotine

US Patents:	3
Tradenames:	9
Applicants:	18
NDAs:	62
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	941
Patent Applications:	7,315
Drug Prices:	Drug price trends for nicotine
What excipients (inactive ingredients) are in nicotine?	nicotine excipients list
DailyMed Link:	nicotine at DailyMed

See drug prices for nicotine

See drug sales revenues for nicotine

Recent Clinical Trials for nicotine

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

Sponsor	Phase
Anna Stanhewicz, PhD	Early Phase 1
Multidisciplinary Association for Psychedelic Studies	Early Phase 1
Spaulding Rehabilitation Hospital	Early Phase 1

See all nicotine clinical trials

Pharmacology for nicotine

Drug Class

Cholinergic Nicotinic Agonist

Medical Subject Heading (MeSH) Categories for nicotine

Ganglionic Stimulants

Nicotinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for nicotine

N07BA	Drugs used in nicotine dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for NICOTINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NICODERM CQ	Transdermal System	nicotine	7 mg/24 hrs 14 mg/24 hrs 21 mg/24 hrs	020165	1	2014-05-30

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
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210712-001	Sep 6, 2019		OTC	No	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009		OTC	Yes	Yes			Y
Dr Reddys Labs Sa	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	213233-002	Aug 4, 2020		OTC	No	No
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078326-001	Oct 30, 2006		OTC	No	No
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	206393-001	Dec 15, 2016		OTC	No	No

Expired US Patents for nicotine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997
Pfizer Inc	NICOTROL	nicotine	SPRAY, METERED;NASAL	020385-001	Mar 22, 1996
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-004	Aug 2, 1996
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-005	Aug 2, 1996
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-006	Nov 12, 1999

Nicotine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nicotine Products

Introduction

The nicotine market is undergoing significant transformations driven by changing consumer preferences, regulatory pressures, and the emergence of new products. This article delves into the current market dynamics, financial trends, and future projections of the nicotine industry.

Market Size and Growth Projections

The US nicotine market is projected to reach $91.78 billion by 2023, with a Compound Annual Growth Rate (CAGR) of 4.78%[1].

• Globally, the modern oral nicotine products market is expected to grow at a CAGR of 26.2% from 2024 to 2030, reaching $26.42 billion by 2030[4].

Product Segmentation

The nicotine market is segmented into several key categories:

Cigarettes

• Despite declining sales volumes since 2008, cigarettes still dominate the market in terms of value and volume. However, this segment is facing significant challenges, including declining sales and increasing regulatory pressures[2].

Vaping Products

• Vaping products are the second-largest segment and have seen substantial growth. However, their growth is also impacted by regulatory challenges and health concerns[1].

Moist Snuff Tobacco (MST)

• MST remains a stable segment but is not experiencing the same level of growth as newer products like nicotine pouches[1].

Cigars & Cigarillos

• These products continue to have a niche market but are not driving the overall growth of the nicotine market[1].

Nicotine Pouches

• Nicotine pouches are a rapidly growing segment, driven by consumer interest in alternative nicotine products. They dominated the modern oral nicotine products market with a 55.58% share in 2023[4].

Distribution Channels

Offline Distribution

• Offline channels, such as grocery stores and retail outlets, currently lead the market due to widespread availability. However, online channels are expected to grow at a higher rate due to increased advertising and promotional efforts[1].

Online Distribution

• Online sales are becoming increasingly important, especially for new entrants in the industry. Factors such as competitive pricing, discounts, and accessibility are driving this growth[4].

Driving Forces and Challenges

Growing Popularity of Alternative Products

• The shift towards next-generation products like e-cigarettes, nicotine pouches, and oral nicotine products is a significant driver of market growth[1].

Regulatory Pressures

• Increasing taxes on tobacco products and stringent regulations pose significant challenges to the industry. These regulations are aimed at reducing smoking rates and mitigating the health impacts of nicotine consumption[2].

Public Health Concerns

• The harmful effects of nicotine and the rise in nicotine addiction among teenagers are major public health concerns. These issues are driving the growth of the nicotine addiction treatment market[3].

Emerging Trends

Social Media Influence

• Social media is playing a crucial role in shaping consumer behavior and influencing the popularity of nicotine products, particularly among younger demographics[1].

Impact of Party Culture and Pop Culture

• The integration of nicotine products into party and pop culture is another emerging trend, contributing to their increased visibility and appeal[1].

Penetration of Organized Retail Networks

• The expansion of organized retail networks is improving the availability and accessibility of nicotine products, further driving market growth[1].

Tobacco-Free Oral Nicotine Products

• Products like flavored gummies and lozenges are gaining popularity, especially among the youth, presenting both challenges and opportunities for the market[1].

Financial Performance of Tobacco Companies

Declining Cigarette Sales

• Cigarette sales volumes have declined steadily since 2008, and despite efforts to diversify into novel products, these products still generate a small portion of the revenue. For example, novel products accounted for only 10.3% of BAT’s revenue in FY2023[2].

Real Revenue Declines

• Many tobacco companies have experienced real revenue declines since 2016, with six out of nine companies facing reductions in real revenues. This decline is attributed to the inability to offset reduced cigarette sales through price increases and the introduction of new products[2].

Stock Performance

• The stocks of tobacco companies have underperformed the market since 2016, contrasting with their strong performance from 2008 to 2016. This underperformance is a result of declining cigarette sales and the challenges in offsetting these declines with new products[2].

Key Market Players

The US nicotine market is dominated by a few major players:

Altria Group Inc.

• Altria Group Inc. is a market leader in tobacco products and has been able to offset volume declines by increasing cigarette prices, although this strategy is becoming increasingly unsustainable[2].

British American Tobacco (BAT)

• BAT has seen significant growth in its HTP (Heat-Not-Burn) and ENDS (Electronic Nicotine Delivery Systems) sales, but traditional cigarette sales remain the primary revenue source[2].

Philip Morris International Inc.

• Philip Morris has also increased its HTP sales but faces challenges in offsetting the decline in traditional cigarette sales. The company's acquisition of Fertin Pharma highlights its move towards smoke-free nicotine offerings[2][3].

Global Expansion and Regional Insights

North America

• North America is a leading region in the nicotine addiction treatment market and the modern oral nicotine products market, driven by advanced healthcare systems and stringent anti-smoking legislation[3][4].

Europe

• Europe is also experiencing significant growth in the modern oral nicotine products market, driven by shifting attitudes towards smoking, increased health consciousness, and strict smoking regulations[4].

Nicotine Addiction Treatment Market

Market Growth

• The global nicotine addiction treatment market is expected to grow from $3.23 billion in 2023 to $5.24 billion by 2028, driven by government policies, public health campaigns, and innovative treatment methodologies[3].

Teen Tobacco Addiction

• The prevalence of tobacco addiction among teenagers is a critical factor driving the demand for nicotine addiction treatments. Flavored tobacco products are particularly appealing to the youth, leading to a heightened demand for these treatments[3].

Key Takeaways

• The nicotine market is transitioning towards alternative products like nicotine pouches and oral nicotine products.
• Regulatory pressures and public health concerns are significant challenges for the industry.
• Online distribution channels are expected to grow rapidly.
• Major players are diversifying into smoke-free nicotine offerings to mitigate declining cigarette sales.
• The nicotine addiction treatment market is poised for substantial growth driven by public health initiatives and innovative treatments.

FAQs

What is the projected market size of the US nicotine market by 2023?

The US nicotine market is projected to reach $91.78 billion by 2023, with a CAGR of 4.78%[1].

Which segment is dominating the modern oral nicotine products market?

The nicotine pouches segment dominated the modern oral nicotine products market with a 55.58% share in 2023[4].

How are tobacco companies performing financially?

Many tobacco companies have experienced declining real revenues since 2016, and their stocks have underperformed the market. Despite growth in novel products, traditional cigarette sales remain the primary revenue source[2].

What are the key drivers of the nicotine addiction treatment market?

The market is driven by government policies, public health campaigns, and innovative treatment methodologies. The prevalence of tobacco addiction among teenagers is also a significant factor[3].

Which region is leading in the modern oral nicotine products market?

North America is the leading region in the modern oral nicotine products market, driven by advanced healthcare systems and stringent anti-smoking legislation[4].

Sources

1. GlobeNewswire: Shifts in US Nicotine Consumption: A Look at Products, Distribution, and Market Dynamics.
2. BMJ Tobacco Control: Evaluating the financial case for investing in, or divesting from, tobacco companies.
3. GlobeNewswire: Nicotine Addiction Treatment Market Report 2024.
4. Grand View Research: Modern Oral Nicotine Products Market Size Report, 2030.