NAVELBINE Drug Patent Profile

Which patents cover Navelbine, and when can generic versions of Navelbine launch?

Navelbine is a drug marketed by Pierre Fabre and is included in one NDA.

The generic ingredient in NAVELBINE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Navelbine

A generic version of NAVELBINE was approved as vinorelbine tartrate by HIKMA on June 10^th, 2003.

Summary for NAVELBINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	136
Patent Applications:	4,599
Drug Prices:	Drug price information for NAVELBINE
What excipients (inactive ingredients) are in NAVELBINE?	NAVELBINE excipients list
DailyMed Link:	NAVELBINE at DailyMed

See drug prices for NAVELBINE

Recent Clinical Trials for NAVELBINE

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 1/Phase 2
Sun Yat-sen University	Phase 2
Shantou Central Hospital	Phase 2

See all NAVELBINE clinical trials

US Patents and Regulatory Information for NAVELBINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pierre Fabre	NAVELBINE	vinorelbine tartrate	INJECTABLE;INJECTION	020388-001	Dec 23, 1994		DISCN	Yes	No

Expired US Patents for NAVELBINE

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

International Patents for NAVELBINE

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

Country	Patent Number	Title	Estimated Expiration
Canada	1136129	COMPOSES INTERMEDIAIRES UTILES DANS LA SYNTHESE DE DERIVES BIS-INDOLIQUES ET PROCEDE POUR LEUR PREPARATION (INTERMEDIATES USED FOR THE SYNTHESIS OF BIS-INDOLIC DERIVATIVES AND PROCESS FOR THEIR PREPARATION)
European Patent Office	0010458	BIS-INDOLE COMPOUNDS, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM, PROCESS FOR THEIR PREPARATION
France	2448545
France	2434171
France	2434172
Japan	S5531096	NOVEL COMPOUND BISSINDOLINE DERIVATIVE ACTIVE AS DRUG AND ITS MANUFACTURE
Netherlands	990027

Supplementary Protection Certificates for NAVELBINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0010458	SPC/GB96/037	United Kingdom		SPC/GB96/037, EXPIRES: 20040410

Market Dynamics and Financial Trajectory for Navelbine (Vinorelbine)

Introduction

Navelbine, also known as vinorelbine, is a chemotherapeutic agent used primarily in the treatment of advanced non-small-cell lung cancer (NSCLC) and advanced breast cancer. This article delves into the market dynamics and financial trajectory of vinorelbine, highlighting its launch, market performance, cost-effectiveness, and future projections.

Market Launch and Expansion

In 2019, Alvogen and its subsidiary Lotus Pharmaceuticals made a significant move by launching the generic version of vinorelbine softgel capsules in Europe. This launch marked the first generic version of Pierre Fabre Médicament’s Navelbine® in the European market, covering 23 countries including Germany, France, Spain, Italy, the UK, and others[1].

Market Size and Growth

The global vinorelbine market is expected to see significant growth from 2024 to 2031. According to market reports, the vinorelbine market size is forecasted to increase, driven by the rising incidence of cancer and the need for effective and affordable treatments. The market is segmented by type (oral and injection) and by application, with oral formulations gaining significant traction due to their ease of administration and patient compliance[4].

Cost-Effectiveness Analysis

Vinorelbine has been subject to several cost-effectiveness analyses, particularly in the context of treating NSCLC. Studies have shown that vinorelbine, especially when combined with cisplatin, offers a favorable cost-effectiveness profile. For instance, vinorelbine plus cisplatin added 37 days of life at a cost of $1,570, or $15,500 per year of life gained, compared to vindesine plus cisplatin. This makes it a viable and cost-effective treatment option relative to other chemotherapy regimens[3][5].

Financial Performance

The launch of the generic vinorelbine softgel capsules by Alvogen and Lotus Pharmaceuticals was strategically significant, given the global sales of Navelbine® were $111 million in 2018. By entering the market first with a generic version, these companies positioned themselves to capture a substantial share of the market. The financial performance of vinorelbine is expected to remain strong, driven by its efficacy, favorable toxicity profile, and the increasing demand for cancer treatments[1].

Competitive Landscape

The vinorelbine market is competitive, with several key players including Pierre Fabre Pharmaceuticals Inc., TEVA Pharmaceuticals, Hospira Inc., and others. The entry of generic versions, such as the one by Alvogen and Lotus Pharmaceuticals, has intensified competition, making the market more dynamic and potentially reducing prices. This competition benefits patients by providing more affordable treatment options[4].

Regional Analysis

The market for vinorelbine is geographically diverse, with significant presence in Europe, North America, Asia Pacific, and other regions. Europe, in particular, has seen a robust launch and registration of vinorelbine in multiple countries. The regional analysis indicates that the demand for vinorelbine is consistent across different markets, driven by the universal need for effective cancer treatments[1][4].

Future Projections

The future of the vinorelbine market looks promising, with forecasted revenue growth at the global, regional, and country levels. The market is expected to grow from 2024 to 2031, driven by increasing cancer incidence, aging populations, and advancements in healthcare infrastructure. The oral formulation of vinorelbine is anticipated to have a significant impact on the market due to its ease of administration and patient compliance[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of vinorelbine. The approval and registration process for generic versions, such as the one by Alvogen and Lotus Pharmaceuticals, involve rigorous bioequivalence studies and regulatory clearances. These processes ensure that the generic versions meet the same standards of quality and efficacy as the branded versions, thereby maintaining patient trust and safety[1].

Patient Impact

Vinorelbine has a significant impact on patients, particularly those with advanced NSCLC and breast cancer. The drug offers improved survival rates and a more favorable toxicity profile compared to other chemotherapy agents. For example, vinorelbine plus cisplatin has been shown to add 56 days of life at an additional cost that is considered acceptable in the context of medical interventions[3][5].

Key Takeaways

• Market Launch: Alvogen and Lotus Pharmaceuticals launched the generic version of vinorelbine softgel capsules in Europe in 2019.
• Cost-Effectiveness: Vinorelbine, especially when combined with cisplatin, is cost-effective compared to other chemotherapy regimens.
• Financial Performance: The generic launch has positioned the companies to capture a significant market share, with global sales of Navelbine® previously recorded at $111 million in 2018.
• Competitive Landscape: The market is competitive with multiple key players, including generic versions that intensify competition and reduce prices.
• Future Projections: The market is expected to grow from 2024 to 2031, driven by increasing cancer incidence and advancements in healthcare.

FAQs

What is Navelbine (vinorelbine) used for?

Navelbine (vinorelbine) is used primarily for the treatment of advanced non-small-cell lung cancer (NSCLC) and advanced breast cancer.

Who launched the generic version of vinorelbine in Europe?

Alvogen and its subsidiary Lotus Pharmaceuticals launched the generic version of vinorelbine softgel capsules in Europe in 2019.

How cost-effective is vinorelbine compared to other chemotherapy regimens?

Vinorelbine, especially when combined with cisplatin, is cost-effective, adding 37 days of life at a cost of $1,570, or $15,500 per year of life gained, compared to vindesine plus cisplatin[3][5].

What is the expected market growth for vinorelbine from 2024 to 2031?

The vinorelbine market is expected to grow significantly from 2024 to 2031, driven by increasing cancer incidence, aging populations, and advancements in healthcare infrastructure[4].

Which regions are significant for the vinorelbine market?

The vinorelbine market is geographically diverse, with significant presence in Europe, North America, Asia Pacific, and other regions[1][4].

Sources

1. Alvogen and Lotus Announce First to Launch Generic Version of Navelbine Softgel Capsule in Europe. Biospace.
2. The cost-effectiveness of navelbine alone or in combination with cisplatin in advanced non-small-cell lung cancer. PubMed.
3. Cost-effectiveness analysis of three regimens using vinorelbine for non-small-cell lung cancer. PubMed.
4. Vinorelbine Market Report 2024 (Global Edition). Cognitive Market Research.
5. Overview of economic analysis of Le Chevalier Vinorelbine Study. PubMed.