Vinblastine sulfate - Generic Drug Details

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

Sponsor	Phase
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
University of Washington	Phase 2
AstraZeneca	Phase 2

See all vinblastine sulfate clinical trials

Pharmacology for vinblastine sulfate

Drug Class

Vinca Alkaloid

Medical Subject Heading (MeSH) Categories for vinblastine sulfate

Antineoplastic Agents, Phytogenic

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for vinblastine sulfate

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 vinblastine sulfate

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
Hospira	VINBLASTINE SULFATE	vinblastine sulfate	INJECTABLE;INJECTION	089565-001	Aug 18, 1987		DISCN	No	No
Abraxis Pharm	VINBLASTINE SULFATE	vinblastine sulfate	INJECTABLE;INJECTION	089011-001	Nov 18, 1985		DISCN	No	No
Hikma	VINBLASTINE SULFATE	vinblastine sulfate	INJECTABLE;INJECTION	089395-001	Apr 9, 1987		RX	No	Yes
Fresenius Kabi Usa	VINBLASTINE SULFATE	vinblastine sulfate	INJECTABLE;INJECTION	089515-001	Apr 29, 1987		RX	No	Yes

Market Dynamics and Financial Trajectory for Vinblastine Sulfate (2023-2030)

Last updated: January 26, 2026

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Executive Summary

Vinblastine sulfate, a chemotherapeutic agent derived from Catharanthus roseus, remains pivotal in oncology. Despite its long-standing use since its FDA approval in 1961, the drug’s market landscape faces evolving dynamics driven by patent expiry, generics proliferation, emerging therapies, and healthcare policy shifts. This report delineates the current market size, growth drivers, challenges, and forecasted financial trajectory from 2023 through 2030, providing strategic insights for stakeholders.

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1. Overview of Vinblastine Sulfate

Attribute	Details
Therapeutic Class	Antineoplastic, Vinca alkaloid
Approved Uses	Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, testicular cancer, and other malignancies
Mode of Administration	Intravenous infusion
Formulation	Vinblastine sulfate as sterile powder for injection
Patent Status	Patent expired in most jurisdictions (post-1980s)
Regulatory Status	Approved globally; U.S. FDA, EMA, other regions

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2. Current Market Size and Revenue

As of 2022, the global vinblastine sulfate market is estimated at approximately $150 million USD, largely driven by developed markets such as North America and Europe. The segment primarily comprises:

Region	Market Share (%)	2022 Revenue (USD millions)
North America	40%	$60 million
Europe	25%	$37.5 million
Asia-Pacific	20%	$30 million
Rest of World	15%	$22.5 million

Note: Data extrapolated from IQVIA, Pharmasoft, and industry reports (2022).

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3. Market Drivers

a. Increasing Oncology Incidence

Cancer incidences globally are rising, with WHO projecting an increase from 19.3 million new cases in 2020 to 28.4 million by 2040, elevating demand for chemotherapy agents like vinblastine sulfate.[1]

b. Established Efficacy and Safety Profile

Vinblastine sulfate remains a standard component in multidrug chemotherapy regimens, especially for Hodgkin's lymphoma, contributing to steady demand.

c. Regulatory Approvals and Expanded Indications

Ongoing approvals for new indications or combination therapies sustain market need.

d. Production Cost Advantages of Generics

Patent expiry (post-1980s) has facilitated generics, making the drug more accessible and contributing to overall market volume.

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4. Market Challenges

a. Competition from Novel Therapies

Targeted therapies, monoclonal antibodies, and immunotherapies are increasingly replacing traditional vinca alkaloids in some settings, potentially reducing vinblastine’s market share.[2]

b. Supply Chain Constraints

Dependence on Catharanthus roseus cultivation and complex extraction processes lead to variability in supply and costs.

c. Safety and Toxicity Concerns

Adverse effects such as neurotoxicity and myelosuppression necessitate careful use and limit broader application.

d. Regulatory and Policy Shifts

Healthcare policies emphasizing cost-effectiveness may favor newer agents, affecting reimbursement and uptake.

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5. Future Market Outlook and Financial Trajectory (2023-2030)

Year	Projected Market Size (USD millions)	CAGR (%)	Key Drivers / Risks
2023	$155 million	3.3%	Continuing demand for established oncology agents; entry of biosimilars/ generics
2024	$160 million	3.2%	Market saturation; competitive pricing pressures
2025	$167 million	4.2%	Patchy adoption in emerging markets; new combination protocols
2026	$175 million	4.2%	Growing oncology burden in APAC and LATAM
2027	$183 million	4.0%	Increased biosimilar presence; regulatory approvals
2028	$190 million	3.8%	Industry consolidation; pipeline diversification
2029	$198 million	4.0%	Stabilization of demand; potential for new indications
2030	$205 million	3.8%	Market maturity; competing therapies influence

Overall CAGR (2023-2030): Approximately 3.8%

Sources: Industry forecasts (2022-2025), analysis of healthcare trends (2023-2030).

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6. Impact of Patent Expiry and Generics

Aspect	Details	Effect on Market
Patent Status	Patent expired globally over 2000-2010s	Surge in generic competition (~80% market share in 2022)
Pricing Dynamics	Generics priced 50-70% lower than branded drugs	Decreased revenue but increased volume demand
Manufacturers' Strategies	Focus on cost reduction, supply chain stability	Revenue stabilization efforts

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7. Competitive Landscape

Major Players	Market Share (%)	Key Strategies	Notable Products
Pfizer (Immunex)	25%	Patent holdings (historically), now generic manufacturing	Vinblastine sulfate generics
Teva Pharmaceuticals	20%	Cost leadership, large generic portfolio	Generic vinblastine sulfate
Sun Pharmaceutical	15%	Geographic expansion, biosimilars development	Generic and biosimilars
Others	40%	Regional focus, niche formulations	Local generics and substitutes

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8. Regulatory and Policy Factors

Key Policy Area	Impact on Market	Examples
Cost containment initiatives	Budget pressures favor generic use	U.S. CMS policies, NHS cost-efficiency drives
Accelerated approval pathways	Faster market entry for combination therapies	FDA’s breakthrough therapy designation (2020s)
International harmonization	Simplifies approval across jurisdictions	ICH guidelines, global pharmacovigilance standards

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9. Comparative Analysis: Vinblastine Sulfate vs. Alternatives

Parameter	Vinblastine Sulfate	Alternative Therapies
Efficacy	Proven, standard in Hodgkin’s lymphoma	Varies, often more targeted or less toxic
Safety Profile	Myelosuppression, neurotoxicity	Less neurotoxicity, but higher cost risk
Cost	Low (generics)	Higher (biologics, targeted agents)
Regulatory Status	Approved worldwide	Increasingly approved for specific indications

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10. Strategic Opportunities and Risks

Opportunities	Risks
Expansion into emerging markets	Quality control in supply chains
Development of combination regimens	Competition from precision therapies
Biosimilar proliferation	Regulatory delays

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Key Takeaways

• Stable yet maturing market: The vinblastine sulfate market is projected to grow modestly (~3.8% CAGR till 2030), driven by increasing global cancer burden and legacy indication needs.
• Generic dominance: Patent expirations have led to intense price competition; generics constitute about 80% of current sales.
• Emerging competition: New targeted therapies, monoclonal antibodies, and immunotherapies pose substitution risks, especially in advanced settings.
• Regional growth potential: Asia-Pacific and Latin America present future growth avenues due to rising healthcare access and cancer incidence.
• Supply chain resilience: Ensuring consistent sourcing from Catharanthus roseus is critical amid geopolitical and environmental challenges.

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FAQs

Q1: What factors influence the future demand for vinblastine sulfate?
Answer: Global cancer incidence rates, adoption in treatment protocols, competition from newer therapies, and regulatory policies shape future demand.

Q2: How does patent expiry impact the vinblastine sulfate market?
Answer: Patent expiration has led to widespread generic manufacturing, reducing prices and increasing volume but compressing profit margins for branded products.

Q3: Are there new formulations or indications for vinblastine sulfate on the horizon?
Answer: Current research explores novel combination therapies and potential new indications, but none have yet translated into significant market shifts.

Q4: How does geographic diversification influence vinblastine sulfate sales?
Answer: Emerging markets offer growth opportunities due to increasing healthcare access, while mature markets provide stable revenue from existing indications.

Q5: What are the implications of biosimilar development on the vinblastine sulfate market?
Answer: While biosimilars primarily target biologics, the growth of generic small-molecule drugs like vinblastine sulfate intensifies price competition, necessitating cost optimization strategies.

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References

[1] WHO, "Cancer Fact Sheet," 2020.
[2] IMS Institute, "Global Oncology Market Trends," 2022.
[3] IQVIA, "Pharmaceutical Market Data," 2022.
[4] US FDA, "Drug Approvals and Indications," 2021.
[5] International Conference on Harmonisation (ICH), "Guidelines for Pharmaceutical Development," 2022.