NICOTROL Drug Patent Profile

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Which patents cover Nicotrol, and when can generic versions of Nicotrol launch?

Nicotrol is a drug marketed by Mcneil Cons, Pfizer, and Pfizer Inc. and is included in three NDAs.

The generic ingredient in NICOTROL 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 Nicotrol

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

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Summary for NICOTROL

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	16
Patent Applications:	4,059
Drug Prices:	Drug price information for NICOTROL
What excipients (inactive ingredients) are in NICOTROL?	NICOTROL excipients list
DailyMed Link:	NICOTROL at DailyMed

Drug patent expirations by year for NICOTROL

Recent Clinical Trials for NICOTROL

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

Sponsor	Phase
Duke University	Early Phase 1
National Institute on Drug Abuse (NIDA)	Early Phase 1
National Institute of Mental Health (NIMH)	Phase 2

See all NICOTROL clinical trials

Pharmacology for NICOTROL

Drug Class	Cholinergic Nicotinic Agonist

US Patents and Regulatory Information for NICOTROL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mcneil Cons	NICOTROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020536-001	Jul 3, 1996		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Pfizer Inc	NICOTROL	nicotine	SPRAY, METERED;NASAL	020385-001	Mar 22, 1996		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NICOTROL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997	⤷ Subscribe	⤷ Subscribe
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997	⤷ Subscribe	⤷ Subscribe
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997	⤷ Subscribe	⤷ Subscribe
Mcneil Cons	NICOTROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020536-001	Jul 3, 1996	⤷ Subscribe	⤷ Subscribe
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997	⤷ Subscribe	⤷ Subscribe
Pfizer Inc	NICOTROL	nicotine	SPRAY, METERED;NASAL	020385-001	Mar 22, 1996	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NICOTROL

See the table below for patents covering NICOTROL around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2701951		⤷ Subscribe
Sweden	463959	NIKOTINAVGIVANDE ANORDNING SAMT FOERFARANDE FOER TILLVERKNING AV ANORDNINGEN	⤷ Subscribe
United Kingdom	9200047		⤷ Subscribe
New Zealand	238285	NICOTINE INHALER CARTRIDGE: NICOTINE RESERVOIR WITH PENETRABLE SEAL	⤷ Subscribe
World Intellectual Property Organization (WIPO)	9118636		⤷ Subscribe
Hungary	T73247		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

NICOTROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nicotine Replacement Therapy (NRT) and Nicotrol

Introduction to Nicotrol and NRT

Nicotrol, a brand name for nicotine inhaler, is part of the broader nicotine replacement therapy (NRT) market. NRT products are designed to help individuals quit smoking by reducing nicotine cravings and withdrawal symptoms.

Global NRT Market Overview

The global NRT market was valued at USD 31,321.4 million in 2023 and is projected to grow at a CAGR of 8.6% from 2024 to 2034, reaching USD 79,041.6 million by 2034[3].

Segmentation of NRT Market

The NRT market is segmented into various products, including nicotine gums, lozenges, patches, sprays, and inhalers. Nicotine inhalers, such as Nicotrol, are a significant segment within this market.

Market Size and Growth of Nicotine Inhalers

The nicotine inhaler market, which includes Nicotrol, was valued at USD 37 million in 2023 and is expected to grow at a CAGR of 4.4% from 2024 to 2030, reaching USD 49 million by 2030[4].

Key Drivers of Market Growth

Several factors are driving the growth of the NRT market, including:

Increased Awareness and Smoking Cessation Efforts

There is a growing awareness of the health risks associated with smoking, leading to increased efforts to quit. This has resulted in higher demand for NRT products[1][3].

Regulatory Support

Regulatory frameworks, such as those set by the FDA, are evolving to support the development and use of NRT products. The FDA's comprehensive plan for tobacco and nicotine regulation aims to reduce tobacco-related disease and death[5].

Advancements in Technology and Products

New advancements in NRT formulas, such as mixed treatments and improved administration methods, are attracting customers looking for personalized quitting options. Digital tools like progress tracking apps and support systems are also enhancing the user experience[3].

Distribution Channels

The market is dominated by drug stores and retail pharmacies, which accounted for 45.2% of the market share in 2023 due to their accessibility and strong presence. However, the online segment is anticipated to grow at the fastest CAGR over the forecast period due to the rise in digitization and consumer preference for online platforms[1].

Competitive Landscape

The NRT market is competitive, with key players including Pfizer Inc., GlaxoSmithKline plc, Johnson & Johnson Services, Inc., and others. For nicotine inhalers specifically, companies like Pfizer, Perrigo Company, and Cipla are prominent[3][4].

Financial Trajectory

The financial trajectory of the NRT market, including nicotine inhalers like Nicotrol, is positive. Here are some key financial metrics:

Market Size: The NRT market was valued at USD 31,321.4 million in 2023 and is expected to reach USD 79,041.6 million by 2034[3].
CAGR: The NRT market is growing at a CAGR of 8.6% from 2024 to 2034[3].
Segment Growth: The nicotine inhaler segment, specifically, is growing at a CAGR of 4.4% from 2024 to 2030[4].

Challenges and Limitations

Despite the positive growth trajectory, the market faces challenges such as competition from vaping products and the potential for market saturation. Additionally, regulatory changes and public health campaigns can influence consumer behavior and market dynamics[3].

Innovative Treatments and Research

The development of new treatments, such as the drug candidate SBP-9330, which targets a neuronal signaling pathway underlying addictive behaviors, is also a significant factor. This drug, if successful, could provide a new and effective smoking-cessation treatment, potentially broadening the market[2].

Regulatory Environment

The FDA's comprehensive regulatory plan places nicotine and addiction at the center of tobacco regulation efforts. This approach aims to balance regulation with the encouragement of innovative, less harmful tobacco products[5].

Key Takeaways

The NRT market, including nicotine inhalers like Nicotrol, is growing significantly due to increased awareness of smoking risks and regulatory support.
The market is expected to reach USD 79,041.6 million by 2034, with a CAGR of 8.6%.
Online distribution channels are expected to grow rapidly.
New treatments and technological advancements are enhancing the market.
Regulatory frameworks are evolving to support NRT products.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the NRT market? A: The global NRT market was valued at USD 31,321.4 million in 2023[3].

Q: What is the projected CAGR for the NRT market from 2024 to 2034? A: The NRT market is expected to grow at a CAGR of 8.6% from 2024 to 2034[3].

Q: Which segment of the NRT market is growing the fastest? A: The online segment is anticipated to grow at the fastest CAGR over the forecast period[1].

Q: What are some of the key drivers of the NRT market growth? A: Increased awareness of smoking risks, regulatory support, and advancements in technology and products are key drivers[1][3].

Q: Who are some of the major players in the NRT market? A: Major players include Pfizer Inc., GlaxoSmithKline plc, Johnson & Johnson Services, Inc., and others[3].

Citations

Grand View Research: Smoking Cessation And Nicotine De-addiction Market Report, 2030.
Sanford Burnham Prebys: $11.4 million NIH grant advances drug to treat nicotine addiction.
Fact.MR: Nicotine Replacement Therapy Market Statistics - 2034.
Valuates Reports: Nicotine Inhaler - Market, Report Size, Worth, Revenue, Growth.
FDA: FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease and death.

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