CHANTIX Drug Patent Profile

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

Chantix is a drug marketed by Pf Prism Cv and is included in one NDA.

The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Chantix

A generic version of CHANTIX was approved as varenicline tartrate by ENDO OPERATIONS on August 11^th, 2021.

Summary for CHANTIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	167
Patent Applications:	132
Drug Prices:	Drug price information for CHANTIX
Drug Sales Revenues:	Drug sales revenues for CHANTIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CHANTIX
What excipients (inactive ingredients) are in CHANTIX?	CHANTIX excipients list
DailyMed Link:	CHANTIX at DailyMed

See drug prices for CHANTIX

See drug sales revenues for CHANTIX

Recent Clinical Trials for CHANTIX

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

Sponsor	Phase
Massachusetts General Hospital	Phase 3
Mayo Clinic	Early Phase 1
Duke University	Phase 4

See all CHANTIX clinical trials

Pharmacology for CHANTIX

Drug Class	Cholinergic Receptor Agonist Partial Cholinergic Nicotinic Agonist
Mechanism of Action	Cholinergic Agonists Partial Cholinergic Nicotinic Agonists

Paragraph IV (Patent) Challenges for CHANTIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CHANTIX	Tablets	varenicline tartrate	0.5 mg and 1 mg	021928	5	2010-05-10

US Patents and Regulatory Information for CHANTIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-001	May 10, 2006		DISCN	Yes	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		DISCN	Yes	No

International Patents for CHANTIX

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I262078
Poland	365163
Estonia	200300556
Bulgaria	106908
Turkey	200001840
Luxembourg	91442
Israel	150639	ENANTIOMERS OF ARYL FUSED AZAPOLYCYCLIC COMPOUNDS, PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS

Supplementary Protection Certificates for CHANTIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1044189	300355	Netherlands		300355, 20181113, EXPIRES: 20220425
1044189	SPC021/2008	Ireland		SPC021/2008: 20081105, EXPIRES: 20210925
1044189	PA2008010	Lithuania		PRODUCT NAME: VARENICLINUM TARTRAT; REG. NO/DATE: EU/1/06/360/001-010 20060926
1044189	C01044189/01	Switzerland		PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006
1044189	SPC/GB08/034	United Kingdom		PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928
1044189	CA 2008 00031	Denmark
1044189	PA2008010,C1044189	Lithuania		PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926

CHANTIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chantix (Varenicline)

Introduction

Chantix, known generically as varenicline, is a prescription medication used to help people stop smoking. The market for varenicline has been influenced by several key factors, including health awareness, technological advancements, and regulatory changes. Here, we delve into the market dynamics and financial trajectory of Chantix.

Market Size and Growth

The varenicline market has seen significant growth in recent years. As of 2023, the market size was approximately $1.6 billion, and it is projected to grow to $1.7 billion in 2024 at a compound annual growth rate (CAGR) of 6.3%. By 2028, the market is expected to reach $2.17 billion[1].

Drivers of the Market

Several factors are driving the growth of the varenicline market:

Health Awareness and Smoking Cessation

The increasing awareness of the health risks associated with smoking has led to a higher demand for smoking cessation aids. As more individuals seek to quit smoking for health and well-being reasons, the demand for varenicline has risen[3].

Societal Attitudes and Regulations

A shift in societal attitudes towards smoking, coupled with smoke-free laws, increased taxation on tobacco products, and anti-smoking campaigns, has boosted the adoption of varenicline. These regulatory and societal changes have created a favorable environment for smoking cessation medications[3].

Personalized Medicine

The trend towards personalized medicine has also played a significant role. Healthcare providers are customizing smoking cessation strategies, often including varenicline, to meet individual patient needs. This personalized approach has enhanced the medication's market presence[3].

Integration with Digital Health Solutions

The integration of varenicline with digital health solutions has improved accessibility and adherence to treatment plans. Digital health platforms provide support and monitoring, which can increase the effectiveness of smoking cessation programs[1].

Market Trends and Strategies

Several trends are shaping the varenicline market:

Digital Health Technologies

The integration of varenicline with digital health technologies is a key trend. This includes mobile apps, telehealth services, and other digital tools that support smoking cessation[1].

Combination Therapies

The development of combination therapies that include varenicline along with other medications or behavioral interventions is another significant trend. These combination therapies aim to improve the efficacy of smoking cessation programs[1].

Government Support and Insurance Coverage

Government support and subsidies, as well as expanded insurance coverage, have made varenicline more accessible to a wider population. This increased accessibility has contributed to the market's growth[1].

Impact of Regulatory Changes

Regulatory changes have had a notable impact on the varenicline market:

Recall of Chantix

In July 2021, Pfizer halted the production of Chantix and recalled select lots due to elevated nitrosamine levels. This recall led to a significant decrease in the prevalence of patients prescribed varenicline, with a 74.7% absolute reduction in use by September 2021[4].

Financial Performance

The financial performance of companies involved in the varenicline market reflects the broader market trends:

Pfizer's Financials

Pfizer, the manufacturer of Chantix, reported strong overall revenues in 2022, with $100 billion in total revenues. However, the recall of Chantix in 2021 impacted the sales of this specific product. Despite this, Pfizer's diversified portfolio and other successful products helped maintain overall revenue growth[5].

Segment Revenues

For companies like ENDO, which also operates in the pharmaceutical sector, the branded pharmaceuticals segment has shown resilience. For example, ENDO's Branded Pharmaceuticals segment revenues increased by 16% in the fourth quarter of 2023 compared to the same period in 2022, though this growth was not specifically attributed to varenicline[2].

Regional Market Analysis

The varenicline market varies by region, with different dynamics in different parts of the world:

Asia-Pacific Market

The Asia-Pacific region is a significant market for varenicline, driven by growing health awareness and government initiatives. The market in this region is segmented by type, patient type, and application, with detailed forecasts up to 2033[1].

China and India Markets

China and India are key markets within the Asia-Pacific region. These markets are characterized by strong growth potential due to large populations and increasing health consciousness. The segmentation by type, patient type, and application in these countries provides a detailed view of the market's structure and growth prospects[1].

Challenges and Restraints

Despite the growth, the varenicline market faces several challenges:

High Inflation and Economic Uncertainty

High inflation and economic uncertainty can impact the affordability and accessibility of varenicline. These macroeconomic factors can affect consumer spending on prescription medications[1].

Regulatory Hurdles

Regulatory hurdles, such as the recall of Chantix due to nitrosamine levels, can significantly impact the market. Such events can lead to decreased consumer confidence and reduced sales[4].

Conclusion

The varenicline market, driven by Chantix, is experiencing strong growth due to increased health awareness, societal changes, and technological advancements. Despite challenges such as regulatory issues and economic uncertainty, the market is expected to continue growing, driven by integration with digital health solutions, personalized medicine, and government support.

Key Takeaways

• The varenicline market is projected to grow from $1.6 billion in 2023 to $2.17 billion by 2028.
• Key drivers include health awareness, societal attitudes, personalized medicine, and digital health integration.
• Regulatory changes, such as the recall of Chantix, have impacted market dynamics.
• The Asia-Pacific region, particularly China and India, presents significant growth opportunities.
• Economic uncertainty and regulatory hurdles are potential restraints.

FAQs

What is the current market size of varenicline?

The varenicline market size was approximately $1.6 billion in 2023 and is expected to grow to $1.7 billion in 2024[1].

What are the main drivers of the varenicline market?

The main drivers include growing health awareness, changing societal attitudes towards smoking, personalized medicine approaches, and integration with digital health solutions[3].

How did the recall of Chantix impact the market?

The recall of Chantix in July 2021 due to elevated nitrosamine levels led to a 74.7% absolute reduction in the use of varenicline by September 2021[4].

What are the key trends in the varenicline market?

Key trends include integration with digital health technologies, development of combination therapies, personalized smoking cessation plans, and expanded government support and insurance coverage[1].

Which regions are expected to drive the growth of the varenicline market?

The Asia-Pacific region, particularly China and India, is expected to drive significant growth due to large populations and increasing health consciousness[1].

Sources

1. The Business Research Company: Varenicline Global Market Report 2024
2. ENDO: ENDO REPORTS FOURTH-QUARTER 2023 FINANCIAL RESULTS
3. IMARC Group: Varenicline (Chantix) Manufacturing Plant Project Report 2024
4. JAMA Network: Association of the Chantix Recall With US Prescribing of Varenicline
5. Pfizer: PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES 2023 FINANCIAL GUIDANCE