NICODERM CQ Drug Patent Profile

When do Nicoderm Cq patents expire, and what generic alternatives are available?

Nicoderm Cq is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in NICODERM CQ is nicotine. There are thirty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicotine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nicoderm Cq

A generic version of NICODERM CQ was approved as nicotine by DIFGEN PHARMS on October 20^th, 1997.

Summary for NICODERM CQ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	36
Patent Applications:	4,063
Drug Prices:	Drug price information for NICODERM CQ
DailyMed Link:	NICODERM CQ at DailyMed

See drug prices for NICODERM CQ

See drug sales revenues for NICODERM CQ

Recent Clinical Trials for NICODERM CQ

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

Sponsor	Phase
Rose Research Center, LLC	Phase 3
Foundation for a Smoke Free World INC	Phase 3
National Cancer Institute (NCI)	Phase 1

See all NICODERM CQ clinical trials

Pharmacology for NICODERM CQ

Drug Class

Cholinergic Nicotinic Agonist

Paragraph IV (Patent) Challenges for NICODERM CQ

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 NICODERM CQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996		OTC	Yes	No
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-005	Aug 2, 1996		OTC	Yes	No
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-004	Aug 2, 1996		OTC	Yes	Yes

Expired US Patents for NICODERM CQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-005	Aug 2, 1996	9,205,059
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	8,663,680
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-005	Aug 2, 1996	5,462,745
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-004	Aug 2, 1996	8,075,911

International Patents for NICODERM CQ

See the table below for patents covering NICODERM CQ around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	237810	POLYISOBUTYLENE ADHESIVE COMPOSITION SUBSTANTIALLY FREE OF TACKIFIERS AND PLASTICISERS; TRANSDERMAL ADMINISTRATION DEVICE INCORPORATING SAME
Czech Republic	302035	Prostredek pro transdermální podání nikotinu (Transparent transdermal nicotine delivery devices)
South Africa	200104966	Transparent transdermal nicotine delivery devices.
European Patent Office	1140039	DISPOSITIF TRANSPARENT POUR L'ADMINISTRATION PERCUTANEE DE NICOTINE (TRANSPARENT TRANSDERMAL NICOTINE DELIVERY DEVICES)

NICODERM CQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nicoderm CQ

Introduction

Nicoderm CQ, a nicotine replacement therapy (NRT) patch, is a key product in the smoking cessation market, manufactured by GlaxoSmithKline (GSK). Understanding the market dynamics and financial trajectory of Nicoderm CQ is crucial for assessing its position and future prospects.

Market Share and Competition

Nicoderm CQ is one of the leading brands in the NRT market, although it holds a relatively smaller share compared to other NRT products. As of the data up to 2020, private label or store brands dominated the market with 62.8%, followed by Nicorette (another GSK brand) with 30.7%, and Nicoderm CQ with 5.7% of the total OTC NRT market[1].

The competition in the nicotine patch segment is significant, with Novartis's Habitrol being another major player before it was divested to Dr. Reddy’s due to antitrust concerns raised by the FTC. This divestiture was necessary to preserve competition in the market for nicotine patches[2].

Sales Trends

The sales of Nicoderm CQ, like other NRT products, have shown varying trends over the years. From 2017 to 2020, the overall sales of OTC NRT products, including patches, decreased significantly. Specifically, the dollar sales of patches declined during this period, although there was a seasonal increase in Quarter 1 of each year[1].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the sales of NRT products, including Nicoderm CQ. Starting in Quarter 1 of 2020, there was a significant drop in sales across all NRT product types, likely influenced by the pandemic's effects on consumer behavior and healthcare access[1].

Retail Channels

Most OTC NRT sales, including Nicoderm CQ, occur through xAOCs (all other channels), with a significant portion sold in drug stores. This distribution channel is crucial for the product's visibility and accessibility to consumers[1].

Product Variants and Consumer Preferences

The 24-hour nicotine patch segment, which includes Nicoderm CQ, is expected to maintain a key market share due to increasing demand for these variants. Consumer preferences for longer-lasting patches contribute to the stability of this segment[4].

Financial Performance

The financial performance of Nicoderm CQ is tied to the broader NRT market. The total annual sales of OTC NRT products were approximately $1 billion between 2017 and 2020, with patches accounting for about $137 million in 2020. While the sales of patches decreased during this period, the overall market is expected to grow, driven by increasing awareness of smoking-related health issues and government initiatives[1][5].

Market Growth Projections

The global nicotine replacement therapy market, which includes Nicoderm CQ, is projected to grow at a compound annual growth rate (CAGR) of 6.3% from 2024 to 2028, reaching $4.10 billion by 2028. This growth is attributed to emerging markets and advancements in NRT products[5].

Competitive Landscape

The competitive landscape of the NRT market is dynamic, with key players such as GSK, Novartis, Dr. Reddy’s Laboratories, and Johnson & Johnson Services, Inc. Market players are focusing on launching innovative products to cater to evolving consumer needs. This competition drives innovation and can impact the market share of Nicoderm CQ[4].

Regulatory Environment

The regulatory environment plays a crucial role in the NRT market. The FTC's intervention in the joint venture between GSK and Novartis ensured that competition was maintained by requiring the divestiture of Habitrol. Such regulatory actions can influence the market dynamics and the financial trajectory of Nicoderm CQ[2].

Consumer Awareness and Government Initiatives

Increasing consumer awareness about the health risks associated with smoking and government initiatives to enhance healthcare infrastructure are driving the growth of the NRT market. These factors are expected to positively impact the sales of Nicoderm CQ and other NRT products[4].

Flavor Preferences and Product Innovations

Consumer preferences for flavors, such as mint, also influence the sales of NRT products. Mint was the most common flavor for gum and lozenges, but patches like Nicoderm CQ do not come in various flavors. Innovations in product design, such as the introduction of mini-lozenges, can also affect market trends[1].

Seasonality and Sales Patterns

The sales of Nicoderm CQ patches show seasonality, with significant increases in Quarter 1 of each year. This pattern is not observed in gum and lozenge sales, indicating different consumer behaviors for different NRT products[1].

Key Takeaways

• Market Share: Nicoderm CQ holds a smaller but significant share of the NRT market.
• Sales Trends: Sales of Nicoderm CQ patches have decreased from 2017 to 2020, influenced by the COVID-19 pandemic.
• Retail Channels: Most sales occur through drug stores and other retail channels.
• Financial Performance: Tied to the broader NRT market, which is expected to grow.
• Regulatory Environment: Influenced by FTC actions to maintain competition.
• Consumer Awareness: Driven by increasing awareness of smoking-related health risks.

FAQs

Q: What is the current market share of Nicoderm CQ in the NRT market? A: As of 2020, Nicoderm CQ accounted for 5.7% of the total OTC NRT market[1].

Q: How has the COVID-19 pandemic affected the sales of Nicoderm CQ? A: The pandemic led to a significant drop in sales of NRT products, including Nicoderm CQ, starting in Quarter 1 of 2020[1].

Q: Which retail channels are most important for Nicoderm CQ sales? A: Most sales occur through drug stores and other xAOCs (all other channels)[1].

Q: What are the projected growth rates for the NRT market? A: The global NRT market is expected to grow at a CAGR of 6.3% from 2024 to 2028[5].

Q: How does the regulatory environment impact Nicoderm CQ? A: Regulatory actions, such as the FTC's requirement for Novartis to divest Habitrol, help maintain competition in the market[2].

Cited Sources:

1. Trends in Over-the-Counter Nicotine Replacement Therapy Sales - CDC
2. FTC Puts Conditions on Pharmaceutical Joint Venture Between GlaxoSmithKline and Novartis - FTC
3. Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction - ASPE
4. Nicotine Transdermal Patches Market: The 24-hour Nicotine Patch Segment is Expected to Account for a Key Market Share - BioSpace
5. Global Nicotine Replacement Therapy Market Report 2024 - The Business Research Company