VARENICLINE TARTRATE Drug Patent Profile

Which patents cover Varenicline Tartrate, and what generic alternatives are available?

Varenicline Tartrate 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 TARTRATE 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 Tartrate

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

Summary for VARENICLINE TARTRATE

US Patents:	0
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	38
Patent Applications:	140
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VARENICLINE TARTRATE
DailyMed Link:	VARENICLINE TARTRATE at DailyMed

Recent Clinical Trials for VARENICLINE TARTRATE

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

Sponsor	Phase
Yale University	Phase 2
CTC Bio, Inc.	Phase 1
National Institute on Drug Abuse (NIDA)	Phase 3

See all VARENICLINE TARTRATE clinical trials

Pharmacology for VARENICLINE TARTRATE

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

Medical Subject Heading (MeSH) Categories for VARENICLINE TARTRATE

Nicotinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for VARENICLINE TARTRATE

N07BA	Drugs used in nicotine dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for VARENICLINE TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYRVAYA	Nasal Spray	varenicline tartrate	0.03 mg/spray	213978	1	2023-04-21
CHANTIX	Tablets	varenicline tartrate	0.5 mg and 1 mg	021928	5	2010-05-10

US Patents and Regulatory Information for VARENICLINE TARTRATE

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
Ajanta Pharma Ltd	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	213019-001	Mar 19, 2024	AB	RX	No	No
Leading Pharma	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	217151-002	Jul 25, 2023	AB	RX	No	No
Mylan	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	202019-002	Feb 28, 2024	AB	RX	No	No
Bionpharma	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	217283-001	Mar 6, 2024	AB	RX	No	No

VARENICLINE TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Varenicline Tartrate

Introduction to Varenicline Tartrate

Varenicline tartrate, 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 nicotine cravings. Here, we will delve into the market dynamics and financial trajectory of varenicline tartrate.

Market Size and Growth

The global varenicline market has been experiencing robust growth. As of 2023, the market size was valued at approximately $1.6 billion and is projected to grow to $1.7 billion in 2024, with a compound annual growth rate (CAGR) of 6.1%[1].

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

Market Segmentation

The varenicline market is segmented in several ways:

• By Type: The market is divided into 0.5 mg tablets and 1 mg tablets. These dosages are critical in the treatment regimen, with patients typically starting with a lower dose and increasing as needed[1].
• By Route of Administration: Varenicline can be administered orally, sublingually, or transdermally. Oral administration is the most common method[1].
• By Patient Type: The market caters to smokers, ex-smokers, and pre-quitters. Each group has different needs and response rates to the medication[1].
• By Application: Varenicline is used in hospitals and drug stores. The hospital segment often involves inpatient smoking cessation programs, which have shown significant efficacy[1][2].

Regional Analysis

The varenicline market is analyzed across various regions, including Asia-Pacific, North America, and Europe.

• Asia-Pacific: This region is seeing significant growth due to increasing awareness about smoking-related diseases and government initiatives to reduce smoking rates. Countries like China and India are key markets, with growing demand driven by expanding healthcare infrastructure and increasing disposable incomes[1].
• North America: The North American market is well-established, with the USA being a major contributor. The region benefits from advanced healthcare systems and strong regulatory support for smoking cessation programs[1].

Efficacy and Safety

Varenicline tartrate has been proven to be highly effective in smoking cessation. A study published in PLOS ONE showed that varenicline plus counseling had a significantly higher success rate in continuous smoking abstinence at 104 weeks compared to counseling alone, with 29.2% of participants in the varenicline group remaining abstinent versus 18.8% in the counseling-only group[2].

The medication acts on the α4β2 nicotinic receptor, reducing the pleasurable effects of smoking and easing cravings. It has a longer half-life compared to nicotine replacement therapy, making it particularly effective in inpatient settings[2].

Budgetary Impact and Economic Benefits

The introduction of varenicline has a positive budgetary impact on healthcare systems. In the UK, for example, model estimates suggest that varenicline would 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 Future Outlook

Several trends are shaping the future of the varenicline market:

• Integration with Digital Health Solutions: The integration of varenicline with digital health technologies, such as mobile apps and telehealth services, is expected to enhance patient compliance and outcomes[1].
• Development of Combination Therapies: Research into combination therapies involving varenicline and other smoking cessation aids is ongoing, promising even higher success rates in the future[1].
• Personalized Smoking Cessation Plans: There is an increasing focus on personalized medicine, tailoring smoking cessation plans to individual patient needs, which is expected to improve efficacy[1].
• Government Support and Subsidies: Government initiatives and subsidies play a crucial role in making varenicline more accessible, thereby driving market growth[1].

Challenges and Limitations

While varenicline is highly effective, there are some challenges and limitations to consider:

• Adverse Events: Like any medication, varenicline can have side effects, although studies have shown that these are generally manageable and less frequent than those associated with other smoking cessation therapies[2][5].
• Generalizability: Some studies have limitations related to the population demographics and the lack of blinding, which can affect the generalizability of the results[2].

Key Takeaways

• The global varenicline market is growing robustly, driven by increasing demand for smoking cessation solutions.
• The market is segmented by type, route of administration, patient type, and application.
• Varenicline has proven efficacy in smoking cessation, especially when combined with counseling.
• The medication has a positive budgetary impact on healthcare systems.
• Future trends include integration with digital health solutions, development of combination therapies, and personalized medicine.

FAQs

Q: What is varenicline tartrate used for? A: Varenicline tartrate is used to help people stop smoking by reducing the pleasurable effects of smoking and easing nicotine cravings.

Q: How effective is varenicline tartrate in smoking cessation? A: Varenicline tartrate has been shown to be highly effective in smoking cessation, with studies indicating higher success rates compared to other smoking cessation therapies.

Q: What are the common side effects of varenicline tartrate? A: Common side effects include nausea, headaches, and sleep disturbances, although these are generally manageable.

Q: How does the market segmentation of varenicline tartrate impact its use? A: Market segmentation by type, route of administration, patient type, and application helps in tailoring the treatment to individual patient needs, enhancing efficacy.

Q: What is the projected market size of varenicline tartrate by 2028? A: The market is expected to reach $2.17 billion by 2028, driven by a CAGR of 6.3%.

Cited Sources

1. The Business Research Company: Varenicline Global Market Report 2024.
2. PLOS ONE: Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation.
3. PubMed: Budgetary impact of varenicline in smoking cessation in the United Kingdom.
4. Dataintelo: Varenicline Tartrate Market Research Report 2032.
5. FDA: NDA/BLA Multi-Disciplinary Review and Evaluation - Varenicline Tartrate.