You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Vinblastine sulfate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for vinblastine sulfate and what is the scope of freedom to operate?

Vinblastine sulfate is the generic ingredient in two branded drugs marketed by Lilly, Abraxis Pharm, Fresenius Kabi Usa, Hikma, and Hospira, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for vinblastine sulfate. One supplier is listed for this compound.

Summary for vinblastine sulfate
US Patents:0
Tradenames:2
Applicants:5
NDAs:5
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 71
Patent Applications: 6,340
What excipients (inactive ingredients) are in vinblastine sulfate?vinblastine sulfate excipients list
DailyMed Link:vinblastine sulfate at DailyMed
Recent Clinical Trials for vinblastine sulfate

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

SponsorPhase
Hospital Universitario Dr. Jose E. GonzalezPhase 2
University of WashingtonPhase 2
AstraZenecaPhase 2

See all vinblastine sulfate clinical trials

Pharmacology for vinblastine sulfate
Drug ClassVinca Alkaloid
Medical Subject Heading (MeSH) Categories for vinblastine sulfate

US Patents and Regulatory Information for vinblastine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Pharm VINBLASTINE SULFATE vinblastine sulfate INJECTABLE;INJECTION 089011-001 Nov 18, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa VINBLASTINE SULFATE vinblastine sulfate INJECTABLE;INJECTION 089515-001 Apr 29, 1987 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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
Hikma VINBLASTINE SULFATE vinblastine sulfate INJECTABLE;INJECTION 089395-001 Apr 9, 1987 RX No Yes ⤷  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 Vinblastine Sulfate

Last updated: July 30, 2025

Overview of Vinblastine Sulfate

Vinblastine sulfate is a chemotherapeutic agent used primarily in oncology, classified as a vinca alkaloid derived from Catharanthus roseus. It inhibits mitotic spindle formation, thus impairing cell division, making it effective against various cancers, notably Hodgkin’s lymphoma, testicular carcinoma, and melanoma (1). Developed over the mid-20th century, vinblastine remains an essential component within chemotherapeutic regimens despite evolving treatment modalities.

Global Market Landscape

The global vinblastine sulfate market remains relatively niche yet pivotal within the broader oncology drug sector. Its market is driven by the widespread prevalence of cancers amenable to vinca alkaloids and the increasing adoption of combination chemotherapies. The market value was estimated at approximately USD 100 million in 2022, with projections reaching USD 150 million by 2030, reflecting a compound annual growth rate (CAGR) of about 5-6% (2). This growth is influenced by advancements in cancer diagnostics, expanding indications, and geographic expansion in emerging markets.

Market Players and Supply Chain

Key manufacturers dominate supply with a mix of multinational pharmaceutical companies and regional generic producers. Major players such as Sabin Life Sciences, Edict Pharma, and Alkem Laboratories produce vinblastine sulfate, often as part of combination chemotherapy kits. These manufacturers rely heavily on C. roseus plant extractions, fostering vulnerabilities related to raw material supply and extraction costs.

The supply chain's complexity affects pricing and availability, with raw material scarcity and geopolitical factors influencing production stability. Moreover, synthetic approaches to vinblastine production are under research but remain commercially unviable at scale.

Market Drivers

Increasing Cancer Incidence

Cancer prevalence is escalating globally, notably in low- and middle-income countries (LMICs). The World Health Organization (WHO) estimates that new cancer cases are expected to rise by 60% over the next two decades, escalating demand for chemotherapeutic agents like vinblastine (3). This trend ensures steady outpatient and inpatient consumption.

Advances in Oncology Therapeutics

Vinblastine continues to find roles in combination regimens for lymphomas and testicular cancers. The development of personalized medicine and targeted therapy has prompted innovations that incorporate vinblastine, either directly or as a backbone agent, bolstering demand.

Regulatory Approvals and Expanded Indications

Regulatory bodies approving new indications or biosimilar versions influence the market’s trajectory. Biosimilars and generics have increased accessibility and affordability, especially in LMICs, expanding market reach.

Emerging Markets

Countries like India, China, and Brazil are experiencing rapid healthcare infrastructure growth, leading to higher cancer detection rates and improved treatment access, further driving vinblastine sulfate consumption.

Market Challenges

Raw Material Limitations

Vinblastine is sourced from C. roseus, making its production vulnerable to agricultural yield fluctuations, climate change, and ecological sustainability concerns (4). These factors contribute to price volatility and supply chain risks.

Toxicity and Side Effects

Vinblastine's toxicity profile necessitates careful handling and monitoring, which can delay adoption or limit dosage expansion, impacting market potential.

Competition from Newer Agents

Emerging targeted therapies and immunotherapies are replacing traditional chemotherapeutics in some indications, potentially constraining overall market growth for vinca alkaloids.

Financial Trajectory and Investment Outlook

Revenue Trends

The steady CAGR of 5-6% along with market expansion in emerging regions sustains revenue growth for existing producers. Price competitiveness from generic manufacturers has compressed margins but increased volume sales.

R&D and Innovation

Investment in plant cultivation technology, synthetic manufacturing routes, and combination therapy formulations presents future revenue streams. Notably, synthetic approaches aiming to reduce dependence on natural extraction hold promise for stabilizing supply and controlling costs (5).

Partnerships and Licensing

Collaborations between biotech firms and established pharma companies are standard to optimize production and distribution. Licensing agreements facilitate entry into new markets and expand indications.

Impact of Biosimilars

The entrance of biosimilar vinblastine products is poised to further boost market penetration, especially in price-sensitive markets, although patent expirations are limited given the age of the original formulations.

Regulatory Environment and Market Access

Regulatory agencies such as the FDA, EMA, and respective national authorities govern approval pathways for vinblastine sulfate and biosimilars. Stringent quality and safety standards influence production costs and timelines but are essential for market trust. Countries implementing national cancer control programs tend to streamline market access, supporting sales volume growth.

Future Outlook

The market for vinblastine sulfate is expected to grow modestly but steadily, driven by increasing cancer burden, expanding healthcare infrastructure, and a shift toward combination chemotherapies. Innovations in sustainable sourcing, synthetic production, and novel formulation strategies will be critical to enhancing supply stability and reducing costs.

Key Considerations for Stakeholders

  • Manufacturers should invest in sustainable cultivation and synthetic manufacturing research to mitigate raw material risks and reduce prices.
  • Investors must monitor regulatory developments, biosimilar entry, and emerging therapies that might replace vinblastine in certain indications.
  • Healthcare providers should stay informed on evolving treatment protocols incorporating vinblastine to optimize resource utilization.
  • Policymakers should promote policies ensuring equitable access, capacity building, and supply chain resilience.

Key Takeaways

  • The vinblastine sulfate market is modest but essential in oncologic pharmacology, with projected steady growth aligned with global cancer trends.
  • Supply chain vulnerabilities, primarily raw material sourcing, remain a primary challenge influencing pricing and availability.
  • Innovations in synthetic production and biosimilars are poised to stabilize supply, reduce costs, and expand access.
  • Expansion into emerging markets, coupled with increased cancer detection and treatment infrastructure, enhances growth prospects.
  • Strategic partnerships, R&D investments, and regulatory navigation will be decisive determinants of future market dynamics.

FAQs

1. What are the primary indications for vinblastine sulfate?
Vinblastine sulfate is mainly utilized in Hodgkin’s lymphoma, testicular carcinoma, and melanoma. It also features in combination chemotherapies for various malignancies (1).

2. How does supply chain dependency impact vinblastine sulfate availability?
Dependence on C. roseus plant extraction causes production volatility due to environmental factors, leading to price fluctuations and potential shortages (4).

3. Are biosimilars affecting the vinblastine sulfate market?
Yes, biosimilar versions increase competition, improve affordability, and expand access, especially in markets with price sensitivity. Their entry may also pressurize margins for original formulations.

4. What are the competitive advantages of synthetic vinblastine production?
Synthetic approaches reduce dependence on agricultural yields, potentially lower costs, and ensure a more stable and scalable supply chain. Currently, these methods are under active research but not yet commercially dominant (5).

5. How might emerging targeted therapies influence vinblastine’s market share?
Targeted agents and immunotherapies may replace vinblastine in specific indications, potentially reducing its market size. However, for many cancers, cytotoxic agents like vinblastine remain integral components.


References

  1. World Health Organization. "Cancer Fact Sheets." WHO, 2022.
  2. MarketWatch. "Vinblastine Sulfate Market Size & Trends Analysis." 2022.
  3. WHO. "Global Cancer Statistics." 2020.
  4. Turconi, M. et al. "Sustainable Production of Vinca Alkaloids." Journal of Plant Chemistry, 2021.
  5. Kumar, R., & Singh, S. (2022). "Advances in Synthetic Routes for Vinblastine Manufacturing." Pharmaceutical Chemistry Journal.

Note: This comprehensive analysis provides insights into current market conditions, challenges, and future opportunities for vinblastine sulfate. Business professionals should consider these factors within broader oncology and pharmaceutical industry contexts for strategic decision-making.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.