NICORETTE Drug Patent Profile

When do Nicorette patents expire, and when can generic versions of Nicorette launch?

Nicorette is a drug marketed by Haleon Us Holdings and is included in four NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-two countries.

The generic ingredient in NICORETTE 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

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

Summary for NICORETTE

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	42
Patent Applications:	3,547
Drug Prices:	Drug price information for NICORETTE
What excipients (inactive ingredients) are in NICORETTE?	NICORETTE excipients list
DailyMed Link:	NICORETTE at DailyMed

See drug prices for NICORETTE

Recent Clinical Trials for NICORETTE

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 clinical trials

Pharmacology for NICORETTE

Drug Class

Cholinergic Nicotinic Agonist

Paragraph IV (Patent) Challenges for NICORETTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NICORETTE	Troche/Lozenge (Mini)	nicotine polacrilex	2 mg and 4 mg	022360	1	2015-12-02

US Patents and Regulatory Information for NICORETTE

NICORETTE is protected by three US patents.

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	nicotine polacrilex	GUM, CHEWING;BUCCAL	018612-002	Feb 9, 1996		OTC	Yes	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No			Y
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-004	Sep 25, 2000		OTC	Yes	No
Haleon Us Holdings	NICORETTE (MINT)	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-003	Dec 23, 1998		OTC	Yes	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002		OTC	Yes	Yes
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	018612-004	Sep 25, 2000		OTC	Yes	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-002	Feb 9, 1996		OTC	Yes	Yes			Y

Expired US Patents for NICORETTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009

International Patents for NICORETTE

See the table below for patents covering NICORETTE 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)
Poland	2285411
World Intellectual Property Organization (WIPO)	2009134947
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 Market Analysis and Financial Projection Experimental

Nicorette: Market Dynamics and Financial Trajectory

Market Overview

Nicorette, a brand of nicotine gum, is a key player in the global nicotine replacement therapy (NRT) market. Here’s a detailed look at the market dynamics and financial trajectory of Nicorette and the broader nicotine gum market.

Global Nicotine Gum Market Size and Growth

The global nicotine gum market was valued at USD 1.30 billion in 2022 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, accounting for a significant share. In 2022, North America held a market share of 29.9%, driven by the increasing percentage of health-conscious consumers and government initiatives promoting smoking cessation[1][4].

Key Drivers of Market Growth

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

• Increasing Health Awareness: There is a rising awareness of the health risks associated with smoking, leading more people to seek NRT products like Nicorette[1][3][4].
• Government Initiatives: Campaigns and government initiatives to reduce smoking rates have boosted the demand for NRT products[1][4].
• Product Innovation: The development of more convenient and effective NRT products, such as long-lasting gums and flavored options, is attracting more consumers[1][4].

Competitive Landscape

Nicorette operates in a competitive market with several key players:

• Johnson & Johnson: Known for its Nicorette brand, Johnson & Johnson is a major player in the NRT market[1][4].
• Novartis AG: Another significant player, Novartis AG, offers a range of NRT products[1].
• Cipla Health Limited: Cipla Health Limited is also a notable competitor, focusing on product innovation to capture market share[1].

Financial Performance of Key Players

Kenvue Inc. (Parent Company of Nicorette)

Kenvue Inc., the parent company of Nicorette, reported significant 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.

Market Segments and Distribution Channels

The nicotine gum market is segmented by type, distribution channel, and region:

• Type: The market includes 2mg and 4mg nicotine gum variants, with flavored options gaining popularity[1][4].
• Distribution Channels: Nicotine gum is sold through various channels, including supermarkets/hypermarkets, convenience stores, pharmacies, and online platforms[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the nicotine gum market. While there was a decline in demand in 2020 compared to pre-pandemic levels, the market has since recovered. The pandemic highlighted the importance of health and wellness, which has contributed to the growing demand for NRT products[4].

Future Outlook

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

• Growing Demand: The 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 Takeaways

• The global nicotine gum market is expected 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.

FAQs

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

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

What is the projected growth rate of the global nicotine gum market?

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

Which region dominates the nicotine gum market?

North America dominates the nicotine gum market, accounting for 29.9% of the market share in 2022[1].

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

Key drivers include increasing health awareness, government initiatives, and product innovation[1][3][4].

Who are the major players in the nicotine gum market?

Major players include Johnson & Johnson, Novartis AG, Cipla Health Limited, and others[1].

How has the COVID-19 pandemic affected the nicotine gum market?

The pandemic led to a temporary decline in demand but has since contributed to increased health awareness and demand for NRT products[4].

Sources

1. Grand View Research: Nicotine Gum Market Size, Share & Growth Report, 2030
2. Kenvue Inc.: Kenvue Reports Full Year and Fourth Quarter 2023 Results
3. Transparency Market Research: Smoking Cessation and Nicotine De-Addiction Market Growth 2031
4. Fortune Business Insights: Nicotine Gum Market Size, Growth | Industry Report [2032]