VARENICLINE TARTRATE - Generic Drug Details

What are the generic sources for varenicline tartrate and what is the scope of freedom to operate?

Varenicline tartrate is the generic ingredient in three branded drugs marketed by Oyster Point Pharma, Pf Prism Cv, 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 sixteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Varenicline tartrate has thirty-eight patent family members in nineteen countries.

There are eleven drug master file entries for varenicline tartrate. Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for VARENICLINE TARTRATE

International Patents:	38
US Patents:	10
Tradenames:	3
Applicants:	16
NDAs:	16
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	38
Patent Applications:	305
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VARENICLINE TARTRATE
What excipients (inactive ingredients) are in VARENICLINE TARTRATE?	VARENICLINE TARTRATE excipients list
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
University of Kansas Medical Center	Phase 3

See all VARENICLINE TARTRATE clinical trials

Generic filers with tentative approvals for VARENICLINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
		EQ 1MG BASE	TABLET;ORAL
		EQ 0.5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Ajanta Pharma Ltd	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	213019-002	Mar 19, 2024	AB	RX	No	No
Ajanta Pharma Ltd	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	213019-001	Mar 19, 2024	AB	RX	No	No
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes
Bionpharma	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	217283-002	Mar 6, 2024	AB	RX	No	No
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-002	May 10, 2006		DISCN	Yes	No
Hetero Labs Ltd Iii	VARENICLINE TARTRATE	varenicline tartrate	TABLET;ORAL	214571-001	Oct 23, 2023	AB	RX	No	No

International Patents for VARENICLINE TARTRATE

Country	Patent Number	Title	Estimated Expiration
Denmark	3209295
China	111956803	治疗眼部病状的方法 (Methods of treating ocular conditions)
Mexico	2017005064	METODOS PARA TRATAR AFECCIONES OCULARES. (METHODS OF TREATING OCULAR CONDITIONS.)
European Patent Office	4413974	MÉTHODES DE TRAITEMENT DE TROUBLES OCULAIRES (METHODS OF TREATING OCULAR CONDITIONS)
World Intellectual Property Organization (WIPO)	2016064759
Eurasian Patent Organization	035335	СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ РАССТРОЙСТВ С ПРИМЕНЕНИЕМ ВАРЕНИКЛИНА (METHODS OF TREATING OCULAR DISORDERS USING VARENICLINE)

Supplementary Protection Certificates for VARENICLINE TARTRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1044189	08C0039	France		PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926
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

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.