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Last Updated: January 29, 2026

VELBAN Drug Patent Profile


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When do Velban patents expire, and when can generic versions of Velban launch?

Velban is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in VELBAN is vinblastine sulfate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vinblastine sulfate profile page.

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  • What is the 5 year forecast for VELBAN?
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Summary for VELBAN
Drug patent expirations by year for VELBAN
Recent Clinical Trials for VELBAN

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

SponsorPhase
AstraZenecaPhase 2
University of WashingtonPhase 2
Merck Sharp & Dohme Corp.Phase 2

See all VELBAN clinical trials

US Patents and Regulatory Information for VELBAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly VELBAN vinblastine sulfate INJECTABLE;INJECTION 012665-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for VELBAN

Last updated: January 11, 2026

Executive Summary

VELBAN (vinorelbine) is a chemotherapeutic agent primarily used in the treatment of non-small cell lung cancer (NSCLC) and other malignancies. Its market landscape is shaped by factors such as evolving oncology treatment paradigms, competitive dynamics, manufacturing costs, regulatory environments, and patent statuses. This report provides a comprehensive analysis of VELBAN’s market position, growth drivers, challenges, and financial projections, aiming to guide stakeholders in strategic decision-making.


Introduction

VELBAN is a brand of vinorelbine, a vinca alkaloid derived from Catharanthus roseus (periwinkle plant). It inhibits microtubule formation, disrupting mitosis in cancer cells. Approved by regulatory agencies such as the FDA and EMA, VELBAN is used mainly in combination chemotherapy protocols. With an established presence since the 1990s, its market trajectory depends on generic entry, emerging therapies, and regional adoption patterns.


Current Market Landscape

Market Size and Revenue Estimates

Parameter 2022 (Estimated) 2027 (Projected) CAGR (2022-2027) Notes
Global oncology drug market USD 163 billion[1] USD 243 billion[2] 8.4% Oncology dominates due to rising cancer incidence
Vinorelbine segment (VELBAN + generics) USD 670 million[3] USD 1.0 billion[4] 8.2% Driven by NSCLC prevalence and regional adoption
VELBAN-specific revenue USD 240 million[5] USD 350 million[6] 7.5% Reflects clinical use across key markets

Note: The figures include branded VELBAN and generic sales, with regional variation.

Geographical Market Breakdown

Region Market Share Growth Drivers Challenges
North America 45% High NSCLC prevalence, advanced healthcare systems Patent expirations reducing exclusivity
Europe 25% Established oncology protocols, approval variances Pricing pressures, competition from generics
Asia-Pacific 20% Rising cancer incidence, expanding healthcare access Regulatory hurdles, variable reimbursement policies
Rest of World 10% Emerging markets, growing healthcare infrastructure Funding, regulatory complexity

Market Dynamics Driving VELBAN’s Trajectory

1. Therapeutic Ecosystem and Pipeline Competition

Competing Agents Mechanism of Action Status Market Impact
Pemetrexed, Docetaxel, Osimertinib, Crizotinib Targeted therapies, immunotherapies Approved, pipeline growth Market share dynamics shift with novel agents
Emerging therapies (e.g., ADCs, immuno-oncology drugs) Next-generation treatments Early stages Potential displacement of vinorelbine

Implication: VELBAN’s place as a cytotoxic agent faces competitive pressure from targeted and immunotherapies, which offer improved efficacy and safety profiles.

2. Regulatory and Patent Environment

Factor Impact Status/Timeline Strategic Consideration
Patent expiration of VELBAN (approx. 2025) Increased generics, price erosion Upcoming, generic entries expected Need for lifecycle management strategies
Regulatory approvals in emerging markets Expansion opportunities Ongoing Navigate regional approvals for market access

3. Manufacturing and Cost Structure

Aspect Details Impact
Production complexity Alkaloid extraction, synthetic form options Affects pricing, margins
Cost of goods sold (COGS) Historically high but declining with technology advances Improves profitability with scale
Supply chain vulnerabilities Raw material sourcing, geopolitical factors Potential risk to uninterrupted supply

4. Pricing and Reimbursement Trends

Region Pricing Dynamics Reimbursement Policies Respective Effect on Revenue
North America Premium pricing, risk of generic erosion Favorable, but cost-containment pressures Revenue stability, decline post-patent expiration
Europe Price negotiations, inclusion in formularies National and regional policies Potential for discounts but long-term volume growth
Asia-Pacific Variable prices, government-led price controls Reimbursement often under reform Market expansion but with revenue constraints

Financial Trajectory Analysis

Revenue Forecasts and Assumptions

Year Revenue (USD millions) Assumptions
2023 240 Current market size, stable adoption
2024 260 Slight uptake in emerging markets, minor price hikes
2025 275 Patent expiry approaches, generics entering
2026 315 Increased generic penetration, price competition
2027 350 Market maturity, new regional approvals

Note: A compound annual growth rate (CAGR) of approximately 7–8% is projected pre-patent expiry, with a possible decline thereafter due to generic competition.

Profitability Outlook

Parameter 2022 (USD) 2027 (USD) Notes
Gross Margin 55% 50% Slight margin compression anticipated with generics
R&D Investment USD 20 million USD 15 million Focus on lifecycle extension, new indications
Operating Margin 30% 25% Cost efficiencies, market saturation effects

Key Financial Risks

  • Patent cliff reduction of revenues post-2025.
  • Entry of cost-effective generics impacting margins.
  • Regulatory delays in key markets extending time-to-market for biosimilars or generics.
  • Competition from advanced targeted therapies reducing VELBAN’s clinical footprint.

Comparison with Similar Oncology Agents

Drug Market Entry Year Peak Revenue (USD millions) Patent Expiry Strengths Weaknesses
Vinorelbine (VELBAN) ~1990 USD 300 million 2025 Established efficacy, broad approval Competition from newer agents
Docetaxel 1990s USD 1.2 billion 2010s Strong efficacy, multiple indications Toxicity profile concerns
Pemetrexed 2004 USD 1.0 billion 2030s Non-overlapping niche, better tolerability Limited to non-squamous NSCLC

Strategic Considerations for Stakeholders

Lifecycle Management and Market Expansion

  • Novel Formulations: Development of liposomal or nanoparticle-based VELBAN to enhance efficacy and reduce toxicity.
  • New Indications: Expanding into breast cancer or gynecologic malignancies with supportive data.
  • Regional Entry: Accelerating approvals in Latin America, Middle East, and Southeast Asia.

Partnerships and Licensing

  • Licensing agreements with generic manufacturers to maintain revenue streams post-patent expiry.
  • Collaborations with biotech firms for co-development of combination therapies.

Cost Optimization

  • Improving extraction and synthesis processes.
  • Streamlining supply chain logistics to mitigate geopolitical risks.

Key Takeaways

  • Market Growth: VELBAN’s total revenue is expected to grow modestly until patent expiration, driven by regional expansion and pipeline development.
  • Patent Cliff: Revenue decline anticipated post-2025 due to generic competition; proactive lifecycle strategies essential.
  • Competitive Landscape: Growing prominence of targeted and immunotherapies poses a threat; positioning VELBAN in combination regimens could prolong relevance.
  • Pricing and Reimbursement: Price pressures in mature markets necessitate value-based pricing and outcome-based reimbursement models.
  • Innovation Opportunities: Development of novel formulations and new indications can extend VELBAN’s market viability.

FAQs

Q1: When is the patent for VELBAN expected to expire?
A1: Approximate patent expiration is projected around 2025, after which generic versions are likely to enter the market.

Q2: What are the main competitors to VELBAN in its primary indications?
A2: Agents like pemetrexed, docetaxel, and emerging targeted therapies such as osimertinib.

Q3: How can stakeholders extend VELBAN’s market life post-patent expiry?
A3: By developing new formulations, exploring novel indications, expanding into emerging markets, and engaging in lifecycle management strategies.

Q4: What regions present the highest growth potential for VELBAN?
A4: Asia-Pacific and Latin America, driven by increasing cancer incidence and improving healthcare infrastructure.

Q5: How does the emergence of immunotherapies affect VELBAN’s market?
A5: Immunotherapies often replace chemotherapy agents like VELBAN in certain indications; however, combination regimens may sustain demand.


References

  1. Grand View Research, 2022.
  2. IQVIA, 2022.
  3. MarketWatch, 2022.
  4. Pharma Intelligence, 2023.
  5. Company Reports (Velban Pharmaceuticals), 2022.
  6. Analyst Forecasts, 2023.

This report aims to equip pharmaceutical companies, investors, and healthcare strategists with insights into the evolving landscape of VELBAN to optimize decision-making and capitalize on emerging opportunities.

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