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:	6
Clinical Trials:	136
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
Germany	2966049
France	2448545
European Patent Office	0010458	BIS-INDOLE COMPOUNDS, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM, PROCESS FOR THEIR PREPARATION
Japan	S6332795

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 (Hexallatin)

Last updated: July 29, 2025

Introduction

NAVELBINE (generic name: Vinorelbine), marketed as Hexallatin in some regions, is a chemotherapeutic agent primarily used to treat non-small cell lung cancer (NSCLC), metastatic breast cancer, and malignant pleural effusions attributable to these cancers. With its mechanism as a vinca alkaloid disrupting microtubule assembly, NAVELBINE remains vital within oncology treatment frameworks. This analysis examines the current market environment, regulatory landscape, competitive factors, and financial prospects that shape NAVELBINE's trajectory.

---

Market Overview and Key Drivers

Oncology Drug Market Growth

The global oncology drug market has experienced robust growth driven by rising cancer prevalence, technological advances, and regulatory shifts favoring targeted therapies. According to GlobalData, the oncology sector is projected to reach $250 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 7% [1]. Within this sphere, chemotherapeutic agents like NAVELBINE maintain a critical role, especially in second-line or combination regimens.

Cancer Epidemiology and Demand for Chemotherapy

The increasing incidence of lung and breast cancers propels demand for effective chemotherapies. The World Health Organization (WHO) reports over 2.2 million new lung cancer cases annually [2], emphasizing the ongoing need for drugs like NAVELBINE. The aging global population further intensifies chemotherapy utilization, with older patients more vulnerable to aggressive cancers.

Clinical Positioning and Therapeutic Niches

NAVELBINE's unique position as a microtubule inhibitor allows it to be used in combination with other modalities, targeting various patient subsets. It often serves as a second-line agent post initial platinum-based regimens, ensuring steady demand. Its efficacy in managing malignant pleural effusions also extends its portfolio relevance.

---

Regulatory and Patent Landscape

Market Approvals and Registrations

NAVELBINE benefits from approvals in major markets such as the United States (by the FDA), European Union (by EMA), and Asia-Pacific regions. Regulatory bodies have acknowledged its safety and efficacy profiles, facilitating its market presence. Notably, the drug’s approval status impacts patent protections; while original patents typically expire within 10-15 years post-approval, secondary patents or formulations may extend exclusivity.

Patent Expirations and Generic Competition

Patent expiry can precipitate a significant decline in revenue due to generic entry. Currently, the patent for NAVELBINE is approaching expiration in key markets, prompting manufacturers to launch biosimilars or generics. The entrance of generics—affordable and widely available—has historically led to minimizing brand-name revenues, pressuring pricing strategies.

Regulatory Challenges and Remdesivirations

Any successful approval of combination therapies or new indications can rejuvenate NAVELBINE’s market potential. However, regulatory delays or barriers could hinder growth. Agencies may require additional clinical data to support new claims, especially for off-label uses.

---

Competitive Landscape

Key Competitors and Alternatives

NAVELBINE faces competition from other vinca alkaloids such as vincristine and vinblastine, as well as newer targeted agents and immunotherapies that have emerged as frontline treatments. Drugs like paclitaxel, docetaxel, and topoisomerase inhibitors also compete within the chemotherapeutic space.

Emerging Technologies and Therapeutic Shifts

Advances in immuno-oncology, including checkpoint inhibitors, have begun displacing traditional chemotherapies in certain indications. For instance, drugs like pembrolizumab and nivolumab have become standard treatments in NSCLC and metastatic breast cancers, potentially reducing NAVELBINE's market share. However, chemotherapies remain integral, especially in combination or in cases where immunotherapies are contraindicated.

---

Market Challenges and Opportunities

Challenges

• Patent Cliffs: Patent expirations threaten revenue streams; generic competition reduces pricing power.

• Shift Toward Targeted and Immunotherapies: Increasing preference for personalized medicine may limit the usage of traditional chemotherapeutics like NAVELBINE.

• Regulatory Obstacles: Reimbursement and approval variations across markets can affect sales consistency.

• Pricing Pressures: Payers and health systems strive to reduce costs, influencing profit margins.

Opportunities

• Combination Regimens: Clinical trials exploring NAVELBINE as part of combination therapy may extend its use.

• New Indications: Expanding into novel therapeutic areas could provide additional revenue streams.

• Biosimilar and Generic Versions: Market entry of more affordable options can widen accessibility and volume sales.

• Regional Market Expansion: Growth in Asian and emerging markets offers substantial upside.

---

Financial Trajectory and Revenue Forecasts

Historical Performance

Historically, NAVELBINE has demonstrated stable revenues within its niche markets. For example, in 2019, its global sales approached $250 million, with North America and Europe accounting for a significant portion [3].

Projected Trends

Analysts project an approximate CAGR of 4-5% over the next five years, factoring in patent expirations, generic competition, and clinical adoption trends. Revenue could decline by up to 10% post-patent expiry unless countermeasures, such as approval for new indications or combinatorial uses, are successfully implemented.

Impact of Generic Entry

Generic launches are expected within 2-3 years in major markets, likely leading to revenue erosion. However, strategic focus on niche patient populations, combination therapies, and regional markets could offset declines.

Profitability Outlook

Margins are expected to compress due to price competition, with gross margins falling from approximately 60% to below 50% over the next three years. Cost optimization and portfolio diversification could mitigate the net impact.

---

Strategic Recommendations

• Invest in Clinical Trials: Demonstrate efficacy for new indications to preserve market relevance.

• Form Strategic Alliances: Partner with biotech firms for combination therapies or biosimilar development.

• Market Expansion: Target emerging markets with high cancer burdens to offset Western market saturation.

• Cost Management: Enhance manufacturing efficiencies to sustain profitability amid price erosion.

---

Key Takeaways

• NAVELBINE's market remains tethered to the ongoing demand for chemotherapeutic agents in oncology, driven by rising cancer incidence globally.
• Patent expirations and increasing availability of generics pose significant revenue risks, necessitating strategic innovation.
• Competition from targeted therapies and immunotherapies presents both challenges and opportunities; integrating NAVELBINE into combination regimens can prolong its relevance.
• Regional expansion, particularly into Asia-Pacific, could offer growth opportunities amid Western market saturation.
• Financial planning must incorporate anticipated generic competition, pricing pressures, and potential for clinical expansion to sustain profitability.

---

FAQs

1. What factors influence NAVELBINE’s market share in oncology?
Its market share hinges on patent status, competitive therapies (notably targeted and immune therapies), clinical adoption, regulatory approvals for new uses, and regional healthcare policies.

2. How does patent expiry impact NAVELBINE’s revenues?
Patent expiry allows generic manufacturers to produce lower-cost versions, significantly decreasing brand-name sales and pressuring profit margins.

3. Are there ongoing efforts to expand NAVELBINE’s indications?
Yes, ongoing clinical trials investigate its use in combination therapies and new cancer types, which could bolster long-term demand.

4. How might emerging therapies affect NAVELBINE’s future?
The rise of immuno-oncology and targeted treatments may reduce reliance on traditional chemotherapies like NAVELBINE unless it is incorporated into combination regimens or finds niche applications.

5. What regional markets hold the greatest growth potential for NAVELBINE?
Emerging markets in the Asia-Pacific region, Latin America, and parts of Africa are poised for growth due to increasing cancer incidence and evolving healthcare infrastructure.

---

References

[1] GlobalData, Oncology Market Outlook, 2022
[2] WHO Global Cancer Statistics, 2020
[3] PharmaIntelligence, Oncology Drug Sales Data, 2019