Vinorelbine tartrate - Generic Drug Details

What are the generic drug sources for vinorelbine tartrate and what is the scope of patent protection?

Vinorelbine tartrate is the generic ingredient in two branded drugs marketed by Pierre Fabre, Actavis Totowa, Dr Reddys, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hospira, Jiangsu Hansoh Pharm, Novast Labs, Rising, and Teva Pharms Usa, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for vinorelbine tartrate. Two suppliers are listed for this compound.

Summary for vinorelbine tartrate

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	81
Patent Applications:	7,505
What excipients (inactive ingredients) are in vinorelbine tartrate?	vinorelbine tartrate excipients list
DailyMed Link:	vinorelbine tartrate at DailyMed

Recent Clinical Trials for vinorelbine tartrate

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

Sponsor	Phase
Shanghai Yizhong Pharmaceutical Co., Ltd.	Phase 3
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
Qilu Pharmaceutical Co., Ltd.	Phase 3

See all vinorelbine tartrate clinical trials

Pharmacology for vinorelbine tartrate

Drug Class

Vinca Alkaloid

Anatomical Therapeutic Chemical (ATC) Classes for vinorelbine tartrate

L01CA	Vinca alkaloids and analogues
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for vinorelbine tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ebewe Pharma	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	078408-001	Feb 13, 2008		DISCN	No	No
Fresenius Kabi Usa	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	076849-001	Apr 18, 2005		DISCN	No	No
Pierre Fabre	NAVELBINE	vinorelbine tartrate	INJECTABLE;INJECTION	020388-001	Dec 23, 1994		DISCN	Yes	No
Hikma	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	076461-001	Dec 11, 2003	AP	RX	No	No
Jiangsu Hansoh Pharm	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	091106-001	Sep 26, 2012	AP	RX	No	Yes

Expired US Patents for vinorelbine tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pierre Fabre	NAVELBINE	vinorelbine tartrate	INJECTABLE;INJECTION	020388-001	Dec 23, 1994	4,307,100*PED

Vinorelbine tartrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vinorelbine Tartrate

Market Overview

Vinorelbine tartrate, a chemotherapeutic agent used primarily in the treatment of various cancers, including non-small cell lung cancer and breast cancer, is experiencing significant growth in the global market. Here’s a detailed look at the market dynamics and financial trajectory of vinorelbine tartrate.

Market Size and Growth Projections

The vinorelbine market was valued at USD 420 million in 2023 and is expected to reach USD 650 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.9% from 2024 to 2031[3].

Segmentation

The market is segmented based on several key factors:

By Type

• Vinorelbine tartrate is available in various forms such as tablets, injections, capsules, powder, and solution. The injection form is particularly popular due to its ease of administration and efficacy[3][4].

By Application

• The primary applications include cancer treatment, chemotherapy, oncology, drug combination therapy, and cancer research. The increasing incidence of cancers, especially non-small cell lung cancer and breast cancer, drives the demand for vinorelbine tartrate[3].

By Geography

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Europe is currently the largest market, followed by North America and Asia-Pacific[3][4].

Drivers of Growth

Several factors are driving the growth of the vinorelbine tartrate market:

Rising Incidence of Cancer

• The increasing rates of cancer, particularly non-small cell lung cancer and breast cancer, are fueling the demand for vinorelbine tartrate as a treatment option[3].

Advancements in Oncology

• Research developments in oncology that underscore the safety and effectiveness of vinorelbine tartrate are promoting its use in combination treatments[3].

Personalized Medicine

• The growing emphasis on personalized medicine is driving interest in customized vinorelbine therapy, enhancing the market's growth potential[3].

Clinical Trials and New Formulations

• Continuous clinical trials and research into new formulations and applications are increasing the therapeutic use and accessibility of vinorelbine tartrate[3].

Financial Analysis

Cost-Effectiveness

• Vinorelbine tartrate has been shown to be cost-effective in treating advanced non-small cell lung cancer. For instance, the vinorelbine plus cisplatin regimen added 37 days of life at a cost of $1,570, or $15,500 per year of life gained, which is less than most commonly accepted medical interventions[2].

Market Value

• The vinorelbine tartrate API market is projected to grow from US$ 349 million in 2024 to US$ 476.9 million by 2030, at a CAGR of 5.3% during the forecast period[4].

Competitive Landscape

The competitive landscape of the vinorelbine tartrate market is characterized by several key players:

Major Manufacturers

• Companies such as Pierre Fabre, Mylan N.V., Sandoz International GmbH (Novartis AG), Teva Pharmaceutical Industries Ltd., and Sun Pharmaceutical Industries Ltd. are prominent in the market. Pierre Fabre holds a significant market share, particularly in the vinorelbine tartrate API segment[1][3][4].

Market Share

• Pierre Fabre is the leader in the vinorelbine tartrate API market with about 51% market share, followed by other major manufacturers like Hubei Hongyuan Pharmaceutical Technology, Hansoh Pharmaceutical Group, Minakem, and Qilu Pharmaceutical[4].

Regional Insights

Market Distribution

• Europe is the largest market for vinorelbine tartrate, accounting for about 42% of the market share, followed by North America and China with shares of about 16% and 15%, respectively[4].

Challenges and Opportunities

Challenges

• Despite the growth, the market faces challenges such as the high cost of research and development, regulatory hurdles, and the presence of generic competitors[3].

Opportunities

• Emerging trends in personalized cancer therapies and the development of new formulations offer significant opportunities for market expansion. Additionally, the increasing focus on oncology research and the growing demand for effective cancer treatments provide a favorable environment for the growth of vinorelbine tartrate[3].

Porter’s Five Forces Analysis

Bargaining Power of Buyers

• The bargaining power of buyers is moderate due to the availability of alternative treatments, although vinorelbine tartrate's efficacy and safety profile give it a competitive edge[3].

Bargaining Power of Suppliers

• The bargaining power of suppliers is relatively high due to the limited number of manufacturers and the complexity of the production process[3].

Threat of New Entrants

• The threat of new entrants is low due to the high barriers to entry, including stringent regulatory requirements and significant investment in research and development[3].

Threat of Substitutes

• The threat of substitutes is moderate as there are other chemotherapeutic agents available, but vinorelbine tartrate's unique benefits and cost-effectiveness reduce this threat[3].

Degree of Competition

• The degree of competition is high among the existing players, with companies competing on factors such as product quality, pricing, and innovation[3].

Key Takeaways

• The vinorelbine tartrate market is expected to grow significantly due to the rising incidence of cancer and advancements in oncology.
• The market is driven by the demand for effective and cost-effective cancer treatments.
• Key players such as Pierre Fabre and others dominate the market, with Europe being the largest geographical segment.
• The market faces challenges but also presents opportunities for growth through personalized medicine and new formulations.

FAQs

Q: What is the projected market size of vinorelbine tartrate by 2031?

A: The vinorelbine market is expected to reach USD 650 million by 2031, growing at a CAGR of 4.9% from 2024 to 2031[3].

Q: Which region holds the largest market share for vinorelbine tartrate?

A: Europe holds the largest market share, accounting for about 42% of the market[4].

Q: What are the primary applications of vinorelbine tartrate?

A: The primary applications include cancer treatment, chemotherapy, oncology, drug combination therapy, and cancer research[3].

Q: Who are the major manufacturers of vinorelbine tartrate?

A: Major manufacturers include Pierre Fabre, Mylan N.V., Sandoz International GmbH (Novartis AG), Teva Pharmaceutical Industries Ltd., and Sun Pharmaceutical Industries Ltd.[1][3][4].

Q: What is the cost-effectiveness of vinorelbine tartrate in treating non-small cell lung cancer?

A: Vinorelbine plus cisplatin added 37 days of life at a cost of $1,570, or $15,500 per year of life gained, which is less than most commonly accepted medical interventions[2].

Sources

1. Market Research Intellect: Vinorelbine Tartrate Sales Market Size, Scope And Forecast Report.
2. PubMed: Overview of economic analysis of Le Chevalier Vinorelbine Study.
3. Market Research Intellect: Vinorelbine Market Size and Projections.
4. Valuates Reports: Global Vinorelbine Tartrate API Market Insights, Forecast to 2030.