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Last Updated: December 22, 2024

VARENICLINE Drug Patent Profile


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

Varenicline is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Bionpharma, Dr Reddys, Endo Operations, Hetero Labs Ltd Iii, Indoco, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Piramal, and Zydus. and is included in fourteen NDAs.

The generic ingredient in VARENICLINE 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 Varenicline

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

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Drug patent expirations by year for VARENICLINE
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Recent Clinical Trials for VARENICLINE

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SponsorPhase
National Cancer Institute (NCI)Phase 1
Pradeesh SivapalanPhase 4
Truth InitiativeN/A

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US Patents and Regulatory Information for VARENICLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 216723-002 Jun 12, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ajanta Pharma Ltd VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 213019-001 Mar 19, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Leading Pharma VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 217151-002 Jul 25, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 202019-002 Feb 28, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bionpharma VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 217283-001 Mar 6, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkem Labs Ltd VARENICLINE TARTRATE varenicline tartrate TABLET;ORAL 214557-002 Aug 23, 2023 AB RX No No ⤷  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

VARENICLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Varenicline

Introduction to Varenicline

Varenicline, commonly known by the brand name Chantix, is a prescription medication used to help people stop smoking. It works by reducing the pleasurable effects of smoking and diminishing the withdrawal symptoms associated with quitting.

Market Size and Growth

The varenicline market has experienced significant growth in recent years. As of 2023, the market size was valued at $1.6 billion, and it is projected to increase to $1.7 billion in 2024, with a compound annual growth rate (CAGR) of 6.1%[1][4].

By 2028, the market is expected to expand to $2.17 billion, maintaining a CAGR of 6.3%. This growth is driven by several factors, including advancements in smoking cessation research, expansion into emerging markets, integration with digital health solutions, government support and subsidies, and a heightened focus on personalized medicine[1][4].

Drivers of the Market

Rising Smoking Cessation Initiatives

There is a global increase in initiatives aimed at reducing smoking rates, which has led to a higher demand for effective smoking cessation aids like varenicline. Governments and health organizations are investing more in programs to help people quit smoking, driving the demand for varenicline[1][4].

Regulatory Approvals and Recommendations

Regulatory approvals and recommendations from health authorities have played a crucial role in the growth of the varenicline market. Positive reviews and endorsements from reputable health organizations have increased the confidence of both healthcare providers and patients in using varenicline[1][4].

Effectiveness and Safety Profile

Varenicline has been proven to be effective and safe in numerous clinical trials. Its ability to reduce the pleasurable effects of smoking and minimize withdrawal symptoms makes it a preferred choice among smokers trying to quit. This positive efficacy and safety profile has contributed significantly to its market growth[1][4].

Growing Incidence of Smoking-Related Diseases

The increasing prevalence of smoking-related diseases has heightened the need for effective smoking cessation treatments. As more people become aware of the health risks associated with smoking, the demand for varenicline and other cessation aids is likely to continue growing[1][4].

Market Segmentation

By Type

The varenicline market is segmented by type into 0.5 mg tablets and 1 mg tablets. These different dosages cater to various patient needs and are prescribed based on individual health profiles and smoking habits[4].

By Route of Administration

Varenicline is administered orally, and there are also sublingual and transdermal forms, although oral administration is the most common. The choice of administration route can affect patient compliance and treatment outcomes[4].

By Patient Type

The market is segmented by patient type into smokers, ex-smokers, and pre-quitters. Each group has different needs and responses to the medication, making targeted treatment plans essential[4].

By Application

Varenicline is used in both hospital settings and drug stores. The availability in different healthcare settings ensures that the medication is accessible to a wide range of patients[4].

Regional Analysis

The varenicline market is analyzed across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle East. Each region has its own market dynamics, influenced by local healthcare policies, economic conditions, and the prevalence of smoking.

  • North America: This region is one of the largest markets for varenicline, driven by high awareness of smoking cessation programs and strong healthcare infrastructure[1][4].
  • Europe: Western Europe, in particular, has a significant market for varenicline, with countries like the UK showing a notable increase in the use of this medication for smoking cessation[1][4].
  • Asia-Pacific: This region is expected to see substantial growth due to the large population and increasing awareness of health risks associated with smoking[1][4].

Cost-Effectiveness

Studies have shown that varenicline is highly cost-effective in smoking cessation. A study published in JAMA Network Open found that 12 weeks of standard varenicline treatment was the most cost-effective option, with an incremental cost-effectiveness ratio of $4579 per patient health-related “quality-adjusted life-year”[2].

Comparison of Treatment Durations

The study compared 12 weeks of varenicline alone with 24 weeks of varenicline alone and with 12 and 24 weeks of varenicline combined with nicotine patches. It concluded that extending the treatment beyond 12 weeks or combining it with nicotine patches did not significantly improve quit rates but increased costs[2].

Budgetary Impact

In the UK, the introduction of varenicline was estimated to result in an additional 162,000 successful smoking-cessation attempts and 103,000 fewer smokers over five years, with a modest increase of 0.05% to the total NHS pharmacy budget[3].

Trends and Strategies

Integration with Digital Health Solutions

The integration of varenicline with digital health solutions is a significant trend. Digital platforms can enhance patient compliance and provide additional support through mobile apps, online counseling, and monitoring systems[1][4].

Development of Combination Therapies

There is ongoing research into combination therapies that include varenicline along with other smoking cessation aids like nicotine patches or gum. While some studies suggest that these combinations may not offer significant additional benefits over standard varenicline treatment, they remain a focus of ongoing research[2].

Personalized Smoking Cessation Plans

Personalized medicine is becoming more prominent in the varenicline market. Tailoring treatment plans to individual patient needs and health profiles can improve quit rates and patient satisfaction[1][4].

Government Support and Subsidies

Government support and subsidies play a crucial role in the growth of the varenicline market. Many governments offer programs and subsidies to make smoking cessation aids more affordable, which increases access to varenicline for a broader population[1][4].

Challenges and Restraints

High Inflation and Economic Uncertainty

High inflation and economic uncertainty can impact the market by reducing consumer spending on non-essential healthcare products, including smoking cessation aids. However, the essential nature of varenicline for public health may mitigate some of these effects[4].

COVID-19 Impact

The COVID-19 pandemic has had mixed effects on the varenicline market. While it highlighted the importance of public health initiatives, it also disrupted supply chains and healthcare services, potentially affecting the availability and accessibility of varenicline[4].

Key Takeaways

  • The varenicline market is growing strongly, driven by increasing smoking cessation initiatives and regulatory approvals.
  • The market is expected to reach $2.17 billion by 2028, with a CAGR of 6.3%.
  • Varenicline is highly cost-effective, with 12 weeks of standard treatment being the most cost-effective option.
  • Integration with digital health solutions, development of combination therapies, and personalized medicine are key trends.
  • Government support and subsidies are crucial for market growth.

FAQs

What is the current market size of varenicline?

The current market size of varenicline is $1.6 billion as of 2023, projected to increase to $1.7 billion in 2024[1][4].

What is the expected growth rate of the varenicline market?

The varenicline market is expected to grow at a CAGR of 6.3% from 2023 to 2028, reaching $2.17 billion by 2028[1][4].

What are the key drivers of the varenicline market?

Key drivers include rising smoking cessation initiatives, regulatory approvals, effectiveness and safety profiles, growing incidence of smoking-related diseases, and advancements in smoking cessation research[1][4].

Is varenicline cost-effective?

Yes, varenicline is highly cost-effective. A 12-week standard treatment has been shown to be the most cost-effective option, with an incremental cost-effectiveness ratio of $4579 per patient health-related “quality-adjusted life-year”[2].

What are the major trends in the varenicline market?

Major trends include integration with digital health solutions, development of combination therapies, personalized smoking cessation plans, government expansion, and insurance coverage[1][4].

Sources

  1. ResearchAndMarkets: Varenicline Market Size, Competitors & Forecast to 2028.
  2. UW-CTRI: Study: Standard Varenicline Highly Cost-Effective.
  3. PubMed: Budgetary impact of varenicline in smoking cessation in the United Kingdom.
  4. The Business Research Company: Varenicline Global Market Report 2024.

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