NICORETTE (MINT) Drug Patent Profile

When do Nicorette (mint) patents expire, and what generic alternatives are available?

Nicorette (mint) is a drug marketed by Haleon Us Holdings and is included in two NDAs.

The generic ingredient in NICORETTE (MINT) is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nicorette (mint)

A generic version of NICORETTE (MINT) was approved as nicotine polacrilex by P AND L on March 15^th, 1999.

Summary for NICORETTE (MINT)

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	42
DailyMed Link:	NICORETTE (MINT) at DailyMed

Recent Clinical Trials for NICORETTE (MINT)

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

Sponsor	Phase
NYU Langone Health	Phase 1
Washington State University	Early Phase 1
Office of Dietary Supplements (ODS)	Early Phase 1

See all NICORETTE (MINT) clinical trials

Pharmacology for NICORETTE (MINT)

Drug Class

Cholinergic Nicotinic Agonist

US Patents and Regulatory Information for NICORETTE (MINT)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	NICORETTE (MINT)	nicotine polacrilex	GUM, CHEWING;BUCCAL	018612-003	Dec 23, 1998		OTC	Yes	No
Haleon Us Holdings	NICORETTE (MINT)	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-003	Dec 23, 1998		OTC	Yes	No

International Patents for NICORETTE (MINT)

See the table below for patents covering NICORETTE (MINT) around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1197195	含藥口香糖的調味劑 (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)
Hong Kong	1114767	含藥物口香糖的調味 (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)
Brazil	PI0611520	aromatização de gomas de mascar contendo drogas
Russian Federation	2007146992	ПРИДАНИЕ ВКУСА ЖЕВАТЕЛЬНЫМ РЕЗИНКАМ, СОДЕРЖАЩИМ ЛЕКАРСТВЕННОЕ СРЕДСТВО
Spain	2516650

NICORETTE (MINT) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nicorette (Nicotine Gum)

Global Nicotine Gum Market Size and Growth

The global nicotine gum market, in which Nicorette is a key player, is experiencing significant growth. As of 2022, the market was valued at approximately USD 1.30 billion and is projected to grow at a compound annual growth rate (CAGR) of 5.6% from 2023 to 2030, reaching USD 2.0 billion by 2030[1][4].

Regional Market Share

North America dominates the nicotine gum market, holding a market share of 29.9% in 2022. This dominance is driven by the increasing percentage of health-conscious consumers and government initiatives promoting smoking cessation. Other significant regions include Europe, where countries like the UK, Germany, Italy, and France are seeing increased sales of nicotine products, and the Asia Pacific region, which is expected to witness significant growth due to stringent anti-smoking regulations[1][4].

Market Drivers

Several factors are driving the growth of the nicotine gum market:

Smoking Cessation Programs

Public health campaigns against smoking have raised awareness about the health risks associated with tobacco use, encouraging more individuals to seek effective methods for quitting. Smoking cessation programs have played a crucial role in this trend[3].

Health and Wellness Culture

There is a growing inclination towards health and wellness, leading to a shift away from traditional smoking towards smokeless nicotine products like gums and mints. This cultural shift is particularly evident in regions with high health consciousness[1].

Advancements in Product Technology

Companies like GlaxoSmithKline and Johnson & Johnson are continuously developing new and more efficient products. For example, Johnson & Johnson's long-acting nicotine gum provides a tapering nicotine dosage, making it more convenient for users to combat cravings throughout the day[1].

Emerging Markets

The advancement in emerging economies is a crucial growth determinant. Regions like India and Australia are expected to see high CAGRs of 6.2% and 6.9%, respectively, between 2024 and 2034, due to their large, previously untapped markets[1].

Financial Performance of Key Players

Kenvue Inc. (Parent Company of Nicorette)

Kenvue Inc., the parent company of Nicorette, reported strong financial results in 2023:

• Net Sales: Full-year net sales increased by 3.3% to $15.4 billion, with organic growth of 5.0%[2].
• Adjusted Gross Profit Margin: The adjusted gross profit margin was 58.4%, driven by favorable value realization and supply chain efficiency initiatives[2].
• Operating Income Margin: The adjusted operating income margin was 22.4%, offsetting incremental public company costs and foreign currency headwinds[2].

Impact on Nicorette

While the specific financial performance of Nicorette is not detailed separately, the overall growth and financial health of Kenvue Inc. indicate a positive trajectory for Nicorette. The company's focus on product innovation and expansion in health-conscious markets aligns with the growing demand for NRT products.

Product Innovations and Market Strategies

Nicorette, among other brands, has been innovating to meet the growing demand:

• Flavored Nicotine Gums: The launch of flavored nicotine gums, such as the ice mint lozenge-coated gum introduced by Nicorette in 2019, has been a key strategy to attract more users[4].
• Telemedicine and Remote Support: The integration of telemedicine and remote support services is another trend, providing users with comprehensive support systems to aid in their smoking cessation journey[3].

Future Outlook

The future outlook for Nicorette and the broader nicotine gum market is positive:

• Growing Demand: Increasing awareness of health risks associated with smoking and the rise in health-conscious consumers are expected to drive market growth[1][3][4].
• Market Expansion: The Asia Pacific region, particularly countries like Japan, India, and China, is expected to witness significant growth due to stringent anti-smoking regulations and increasing demand for innovative NRT products[1].

Key Trends

Several key trends are anticipated in the forecast period:

• Launch of New Products: Continuous development of new products, such as long-acting nicotine gums and flavored variants, will continue to drive market growth[1][3].
• Strategic Collaborations: Collaborations with healthcare providers and the integration of telemedicine services will enhance the support available to users, making NRT products more effective[3].

Regional Growth Projections

• USA: Expected to grow at a CAGR of 4.6% between 2024 and 2034[1].
• UK: Expected to grow at a CAGR of 4.1% between 2024 and 2034[1].
• Japan: Expected to grow at a CAGR of 5.8% between 2024 and 2034[1].
• India: Expected to grow at a CAGR of 6.2% between 2024 and 2034[1].
• Australia: Expected to grow at a CAGR of 6.9% between 2024 and 2034[1].

Illustrative Statistics

• The global nicotine gums and mints market is estimated to reach approximately USD 1,536.2 million by the end of 2024 and is forecasted to exceed USD 2,699.6 million by 2034, with a CAGR of 5.8%[1].
• The nicotine gum market is expected to grow from $1.66 billion in 2023 to $1.75 billion in 2024 at a CAGR of 5.6% and reach $2.19 billion by 2028[3].

Key Takeaways

• The global nicotine gum market is projected to grow at a CAGR of 5.6% from 2023 to 2030.
• North America dominates the market, driven by health-conscious consumers and government initiatives.
• Key players like Johnson & Johnson and Cipla Health Limited are focusing on product innovation.
• The financial performance of Kenvue Inc. indicates a strong foundation for Nicorette’s growth.
• The market is segmented by type, distribution channel, and region, with online sales becoming increasingly important.

Frequently Asked Questions (FAQs)

1. What is the current market size of the global nicotine gum market?

The global nicotine gum market was valued at approximately USD 1.30 billion in 2022[1].

2. What is the projected growth rate of the nicotine gum market?

The market is projected to grow at a CAGR of 5.6% from 2023 to 2030[1].

3. Which region dominates the nicotine gum market?

North America dominates the nicotine gum market, holding a market share of 29.9% in 2022[1][4].

4. What are the key drivers of the nicotine gum market growth?

Key drivers include smoking cessation programs, a growing health and wellness culture, advancements in product technology, and the expansion into emerging markets[1][3].

5. What are some of the innovative trends in the nicotine gum market?

Innovative trends include the launch of flavored nicotine gums, advancements in formulations, the integration of telemedicine and remote support services, and strategic collaborations with healthcare providers[3].

Sources:

1. Future Market Insights: Nicotine Gums and Mints Market Analysis Through 2034.
2. Haleon: Annual Report and Form 20-F 2023.
3. Research and Markets: Nicotine Gum Global Market Report 2024.
4. Fortune Business Insights: Nicotine Gum Market Size, Growth | Industry Report [2032].