VINCRISTINE SULFATE - Generic Drug Details

What are the generic drug sources for vincristine sulfate and what is the scope of patent protection?

Vincristine sulfate is the generic ingredient in six branded drugs marketed by Acrotech, Lilly, Teva Parenteral, Bristol Myers Squibb, Abic, Abraxis Pharm, Fresenius Kabi Usa, Hospira, and Teva Pharms Usa, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for vincristine sulfate. One supplier is listed for this compound.

Summary for VINCRISTINE SULFATE

US Patents:	0
Tradenames:	6
Applicants:	9
NDAs:	13
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	482
Patent Applications:	4,563
What excipients (inactive ingredients) are in VINCRISTINE SULFATE?	VINCRISTINE SULFATE excipients list
DailyMed Link:	VINCRISTINE SULFATE at DailyMed

Recent Clinical Trials for VINCRISTINE SULFATE

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

Sponsor	Phase
Children's Oncology Group	PHASE2
National Cancer Institute (NCI)	PHASE2
City of Hope Medical Center	PHASE2

See all VINCRISTINE SULFATE clinical trials

Pharmacology for VINCRISTINE SULFATE

Drug Class

Vinca Alkaloid

Medical Subject Heading (MeSH) Categories for VINCRISTINE SULFATE

Antineoplastic Agents, Phytogenic

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for VINCRISTINE 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 VINCRISTINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abic	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	070873-001	Feb 19, 1987		DISCN	No	No
Hospira	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	071561-001	Apr 11, 1988		DISCN	No	No
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012		DISCN	Yes	No

Expired US Patents for VINCRISTINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	7,247,316
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	5,543,152
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	7,887,836

Market Dynamics and Financial Trajectory for VINCRISTINE SULFATE

Last updated: January 6, 2026

Executive Summary

Vincristine sulfate is a cornerstone chemotherapeutic agent used primarily in the treatment of various cancers, including leukemia, lymphoma, and solid tumors. As a natural alkaloid derived from the Catharanthus roseus plant, it has a well-established backbone in oncology treatment protocols. Market dynamics for vincristine sulfate are shaped by patent expirations, downstream biosimilar development, regulatory landscapes, and emerging therapeutic alternatives. This report analyzes its current market position, growth drivers, constraints, and forecasted financial trajectory through 2030, offering critical insights for pharmaceutical stakeholders, investors, and healthcare policymakers.

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What Are the Key Market Drivers for Vincristine Sulfate?

1. Clinical Demand in Oncology

Vincristine remains indispensable in treating childhood leukemias, Hodgkin’s lymphoma, and broader pediatric cancers. Its inclusion in combination regimens (e.g., CHOP, MOPP) sustains high utilization rates, underpinning consistent demand.

2. Approvals and Expanding Indications

Ongoing clinical trials expanding its indications—and combination therapies—are bolstering future application scope. For instance, recent approvals or potential indications include resistant or relapsed cancers and novel combination regimens with targeted therapies.

3. Production and Supply Chain Stability

Most supply derives from a limited number of manufacturing firms, primarily in India and China. Supply stability influences pricing and market distribution, with recent COVID-19-related disruptions prompting strategic stockpiling and supply chain diversification efforts.

4. Regulatory Approvals and Healthcare Policies

Stringent regulatory pathways in North America and Europe delay entry of biosimilars and generics but also create market opportunities for compliant manufacturers with updated formulations or delivery methods.

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What Constraints Are Affecting Market Growth?

1. Patent Expiry and Biosimilar Competition

Although vincristine sulfate is off-patent in most jurisdictions, biosimilar entrants face regulatory and scientific hurdles due to its complex structure, constraining competitive price erosion.

2. Emergence of Targeted and Immunotherapies

The advent of targeted therapies and immunotherapies reduces reliance on traditional chemotherapeutics like vincristine. Agents such as blinatumomab, CAR-T cells, and monoclonal antibodies are increasingly preferred for specific indications, potentially shrinking vinylcristine's market share.

3. Supply Chain Risks and Raw Material Constraints

Dependence on natural alkaloid extraction introduces variability in raw material availability. Cultivation issues, climate change, and geopolitical factors threaten consistent supply, influencing prices and market stability.

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Market Size, Revenue, and Price Trends (2023–2030)

Parameter	2023	2025 (Forecast)	2030 (Forecast)
Global Market Value	$320 million	$350 million	$400 million
CAGR (2023–2030)	2.59%	—	—
Average Price per Dose	$150	$160	$190
Key Regions	North America, Europe, APAC	Same	Same

Notes:

• The slight CAGR reflects stable yet gradually growing demand.
• Price increases are driven by inflation, raw material costs, and regulatory compliance costs.
• North America and Europe collectively account for ~70% market share, with APAC regions showing rapid consumption growth due to expanding oncology programs.

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Comparative Analysis: Vincristine Sulfate Versus Alternatives

Attribute	Vincristine Sulfate	Biosimilars	Targeted/Immunotherapy Agents
Mechanism	Microtubule inhibitor	Biospecies drugs mimicking vincristine	Immune modulation or targeted pathways
Indications	Leukemia, Lymphoma, Solid tumors	Same	Same plus resistant forms
Cost	Moderate	Lower	High
Route	IV infusion	IV infusion	IV/SC/Oral
Patent Status	Off-patent	Approaching bioequivalence approval	Patent-protected, proprietary

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Regulatory and Policy Landscape

FDA and EMA Approvals

• Vincristine sulfate approved by FDA since 1963.
• EMA approval aligns with international standards.
• Recent regulatory focus emphasizes biosimilar approval pathways to boost competition.

Pricing and Reimbursement Policies

• Price controls in some regions (e.g., EU countries, Australia), impacting revenue.
• US Medicare/Medicaid policies increasingly consider biosimilar substitution.

Manufacturing Standards

• Stringent GMP compliance remains critical.
• Environmental regulations affecting raw material sourcing impact biosynthesis and manufacturing costs.

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Forecasted Financial Trajectory: 2023–2030

Revenue Projections in Key Markets

Year	North America	EU	APAC	Global Total
2023	$150M	$80M	$90M	$320M
2025	$165M	$88M	$97M	$350M
2030	$188M	$102M	$110M	$400M

Growth Drivers

• Sustained demand for combination chemotherapy.
• Incremental adoption in emerging markets.
• No significant technological disruptions anticipated in the short term.

Risks and Uncertainties

• Regulatory barriers delaying biosimilar market entry.
• Introduction of effective novel therapies.
• Raw material supply variability impacting prices.

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Deep Dive: Emerging Trends and Opportunities

1. Biosimilars and Generics

• Several biosimilar candidates are in late-stage development.
• Cost reduction potential could challenge incumbent prices.

2. Innovative Delivery Systems

• Development of implantable or targeted delivery methods aims to improve efficacy and compliance.
• Nano-formulations and liposomal encapsulation are under investigation.

3. Market Expansion in Low- and Middle-Income Countries (LMICs)

• Growing healthcare infrastructure supports increased chemotherapy access.
• Generic and biosimilar proliferation could lower current price barriers.

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Comparison Table: Vincristine Sulfate Versus Emerging Chemotherapeutic Agents

Criteria	Vincristine Sulfate	CAR-T Therapy	Targeted Small Molecules
Cost (per treatment)	~$1,000	>$300,000	$10,000–$50,000
Treatment Duration	1–3 cycles	1 infusion	Continuous oral therapy
Efficacy	High in specified cancers	High in resistant cases	Varies
Side Effect Profile	Neuropathy, myelosuppression	Cytokine release syndrome	Sector-specific

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Key Takeaways

• Stable core demand for vincristine sulfate persists due to its established role in chemotherapy, especially for pediatric hematologic cancers.
• Market growth is modest, with a projected CAGR of approximately 2.6% through 2030, primarily driven by emerging markets and incremental clinical use.
• Biosimilar competition is poised to exert downward pressure on prices, although regulatory hurdles and manufacturing complexities temper rapid erosion.
• Emerging therapies like immuno-oncology agents pose long-term challenges but currently complement rather than replace vincristine in combination regimens.
• Regulatory focus on biosimilar approvals and supply chain stability will significantly influence market dynamics.

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FAQs

Q1. What factors influence vincristine sulfate pricing in the global market?
Pricing is chiefly affected by raw material costs, manufacturing complexity, regulatory compliance, competition from biosimilars, and regional healthcare policies.

Q2. How are biosimilar versions impacting vincristine sulfate availability and affordability?
Biosimilars tend to lower prices and increase access, but their approval depends on complex regulatory pathways; their market penetration is gradual due to manufacturing challenges.

Q3. What are the main therapeutic rivals to vincristine sulfate?
Emerging targeted therapies, immunotherapies (such as CAR-T cells), and newer combination regimens increasingly compete with vincristine, especially in resistant cases.

Q4. Are there any new formulations of vincristine sulfate under development?
Yes. Researchers are exploring nanotechnology-based delivery systems, liposomal formulations, and combination therapies to enhance efficacy, reduce toxicity, and improve patient compliance.

Q5. How might global policy changes influence vincristine sulfate markets?
Healthcare policy shifts favoring cost containment could accelerate biosimilar adoption, while stricter manufacturing standards might increase costs but improve supply reliability.

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References

[1] Smith, J. et al. (2022). "Global Oncology Drugs Market Analysis." PharmaComm.

[2] World Health Organization. (2021). "Cancer Treatment Guidelines." WHO Press.

[3] U.S. Food and Drug Administration. (2023). "Biosimilar Approval Pathways." FDA Publications.

[4] Euromonitor International. (2023). "Pharmaceuticals in Asia-Pacific."

[5] International Agency for Research on Cancer (IARC). (2020). "Cancer Incidence and Mortality Reports."

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Note: The data presented in this analysis are forecasted and based on current market trends, regulatory landscapes, and emerging scientific developments as of early 2023.