Nicotine polacrilex - Generic Drug Details

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

Nicotine polacrilex is the generic ingredient in four branded drugs marketed by 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, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac, and is included in fifty-five NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicotine polacrilex has forty-four patent family members in twenty-two countries.

There are eleven drug master file entries for nicotine polacrilex. Sixty-one suppliers are listed for this compound.

Summary for nicotine polacrilex

International Patents:	44
US Patents:	3
Tradenames:	4
Applicants:	12
NDAs:	55
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	61
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	22
Patent Applications:	7,276
Drug Prices:	Drug price trends for nicotine polacrilex
What excipients (inactive ingredients) are in nicotine polacrilex?	nicotine polacrilex excipients list
DailyMed Link:	nicotine polacrilex at DailyMed

See drug prices for nicotine polacrilex

See drug sales revenues for nicotine polacrilex

Recent Clinical Trials for nicotine polacrilex

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
22nd Century Group, Inc.	Phase 1
Vince & Associates Clinical Research, Inc.	Phase 1

See all nicotine polacrilex clinical trials

Pharmacology for nicotine polacrilex

Drug Class

Cholinergic Nicotinic Agonist

Anatomical Therapeutic Chemical (ATC) Classes for nicotine polacrilex

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 POLACRILEX

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 nicotine polacrilex

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	078546-001	May 24, 2007		OTC	No	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	8,501,164		Y
L Perrigo Co	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	076777-001	Sep 16, 2004		OTC	No	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009		OTC	Yes	Yes	8,501,164		Y
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	091349-001	Jul 20, 2011		OTC	No	No
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078547-001	May 24, 2007		OTC	No	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	8,940,772		Y

Expired US Patents for nicotine polacrilex

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002	5,110,605
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009	5,110,605
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002	5,110,605
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009	5,110,605

International Patents for nicotine polacrilex

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1153146	尼古丁錠劑組合物 (NICOTINE LOZENGE COMPOSITIONS)
Brazil	PI0911847	composições de pastilhas de nicotina
Australia	2009243065	Nicotine lozenge compositions
European Patent Office	1888042	AROMATISANT POUR CHEWING GUMS CONTENANT UN MEDICAMENT (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)
China	108578392	含药口香糖的调味剂 (Flavoring of drug-containing chewing gums)
Japan	5893405
Canada	2608531	AROMATISANT POUR CHEWING GUMS CONTENANT UN MEDICAMENT (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)

Nicotine polacrilex Market Analysis and Financial Projection Experimental

Nicotine Polacrilex Market Dynamics and Financial Trajectory

Market Overview

The nicotine polacrilex market is a segment of the broader nicotine replacement therapy (NRT) market, which has been growing steadily due to increasing global efforts to reduce smoking and tobacco consumption. Nicotine polacrilex, a key component in many NRT products, is used to help reduce withdrawal symptoms associated with quitting smoking.

Market Size and Growth

As of 2023, the nicotine polacrilex market was valued at approximately USD 1.569 billion. It is projected to reach USD 2.055 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.6% from 2024 to 2031[1][4].

Segmentation

The market is segmented based on several criteria:

Application

• Smoking Cessation
• Nicotine Replacement Therapy
• Quitting Aids
• Pharmaceutical Development
• Behavioral Support[1]

Product

• Nicotine Chewing Gum
• Nicotine Lozenges
• Nicotine Tablets
• Nicotine Inhalers
• Nicotine Nasal Sprays[1]

Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1]

Drivers of Growth

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

Increasing Health Awareness

The growing awareness of the health risks associated with tobacco use is a significant driver. Governments and health organizations are launching initiatives to encourage smoking cessation, which in turn boosts the demand for NRT products containing nicotine polacrilex[1][4].

Government Initiatives and Policies

Regulatory support and government initiatives aimed at reducing smoking rates contribute to the market's expansion. These initiatives often include making NRT products more accessible through various distribution channels[1][4].

Technological Advancements

Innovations in product formulation and delivery systems are enhancing the market potential. New flavors, delivery forms, and digital transformations are making NRT products more appealing and convenient for consumers[4].

Consumer Preference

There is a growing consumer preference for NRTs due to their effectiveness and convenience. Products like nicotine lozenges, gums, and inhalers are becoming more popular as they help reduce withdrawal symptoms and nicotine cravings[1][3].

Key Players

The market is dominated by several key players:

• GlaxoSmithKline
• Pfizer
• Johnson & Johnson
• Altria
• Philip Morris
• Imperial Brands
• Novartis
• Perrigo
• Mylan
• CAMB[1]
• Bgp Healthcare
• Cambrex Corporate
• Nicobrand
• Alchem International
• Dixie Chemical
• Fertin Pharma[4]

Competitive Landscape

The competitive landscape of the nicotine polacrilex market is characterized by:

Buyers' Bargaining Power

Buyers have moderate bargaining power due to the availability of various NRT products and brands. However, brand loyalty and the effectiveness of specific products can influence buyer behavior[1].

Suppliers' Bargaining Power

Suppliers have significant bargaining power due to the specialized nature of the ingredients and the regulatory requirements involved in manufacturing NRT products[1].

Threat of New Entrants

The threat of new entrants is moderate due to the presence of established brands and the need for significant investment in research, development, and regulatory compliance[1].

Threat of Substitutes

The threat of substitutes, such as e-cigarettes and other cessation methods, is a challenge for the market. However, NRT products remain a preferred choice due to their proven efficacy and regulatory approval[1][4].

Regional Analysis

• North America: Leads the market due to strong regulatory frameworks and a wide range of product offerings.
• Asia-Pacific: Emerging as a key growth area driven by high smoking prevalence and regulatory support for cessation products[1][4].

Challenges

Despite the growth, the market faces several challenges:

Regulatory Hurdles

Regulatory requirements and changes can impact the market. For example, pediatric study requirements and labeling changes can affect product approvals and marketing strategies[2].

Competition from Alternatives

Competition from alternative cessation methods, such as e-cigarettes, poses a challenge. The stigma surrounding nicotine consumption also affects consumer willingness to use these products[4].

Economic Factors

Economic fluctuations and changes in consumer spending habits can influence market growth. However, the essential nature of NRT products tends to mitigate these effects to some extent[4].

Innovations and Trends

Digital Transformation

The market is embracing digital technologies such as AI, IoT, and blockchain to enhance operational efficiency, foster product innovation, and improve customer experiences through personalization[4].

Sustainability Practices

There is a growing focus on sustainability, with companies adopting eco-friendly materials, energy-efficient processes, and waste reduction initiatives to align with consumer preferences and regulatory mandates[4].

New Product Launches

Recent launches, such as Dr. Reddy’s Nicotine Polacrilex Lozenges and JB Chemicals’ NOSMOK medicated nicotine lozenges, indicate ongoing innovation in the market. These products cater to diverse consumer preferences with various flavors and strengths[3].

Financial Trajectory

The financial trajectory of the nicotine polacrilex market is positive, with steady growth projected over the next several years. Here are some key financial metrics:

• Market Value: Expected to grow from USD 1.569 billion in 2023 to USD 2.055 billion by 2031[1].
• CAGR: 4.6% from 2024 to 2031[1].
• Revenue Streams: Primarily driven by sales of NRT products through various distribution channels, including retail pharmacies, online pharmacies, and hospital pharmacies[3].

Key Takeaways

• The nicotine polacrilex market is driven by increasing health awareness, government initiatives, and technological advancements.
• Key players are focusing on product innovation and digital transformation to enhance market share.
• The market faces challenges from regulatory hurdles and competition from alternative cessation methods.
• Sustainability practices and new product launches are trends shaping the market.
• The financial trajectory indicates steady growth with a projected CAGR of 4.6% from 2024 to 2031.

FAQs

1. What is the current market size of the nicotine polacrilex market? The nicotine polacrilex market was valued at approximately USD 1.569 billion in 2023[1].

2. What is the projected growth rate of the nicotine polacrilex market? The market is expected to grow at a CAGR of 4.6% from 2024 to 2031[1].

3. Which regions are leading the nicotine polacrilex market? North America currently leads the market, with the Asia-Pacific region emerging as a key growth area[1][4].

4. What are the main drivers of the nicotine polacrilex market? Key drivers include increasing health awareness, government initiatives, technological advancements, and growing consumer preference for NRT products[1][4].

5. What challenges does the nicotine polacrilex market face? The market faces challenges from regulatory hurdles, competition from alternative cessation methods, and the stigma surrounding nicotine consumption[4].

Citations

[1] Market Research Intellect. Nicotine Polacrilex Market Size, Share, Industry Report 2024-31. November 2024.

[2] FDA. NDA 21330/S-013 - Nicorette® Lozenge. May 23, 2012.

[3] GlobeNewswire. Nicotine Replacement Therapy Market is estimated to be US$ 302.6 billion by 2032 with a CAGR of 16.5% over the forecast period 2022-2032. April 12, 2023.

[4] OpenPR. Nicotine Polacrilex Market Size, Outlook 2031 by Key Companies. October 29, 2024.