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
City of Hope Medical Center	PHASE2
National Cancer Institute (NCI)	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
Bristol Myers Squibb	VINCREX	vincristine sulfate	INJECTABLE;INJECTION	070867-001	Jul 12, 1988		DISCN	No	No
Lilly	ONCOVIN	vincristine sulfate	INJECTABLE;INJECTION	014103-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Fresenius Kabi Usa	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	076296-001	Dec 20, 2002		DISCN	No	No
Lilly	ONCOVIN	vincristine sulfate	INJECTABLE;INJECTION	014103-003	Mar 7, 1984		DISCN	Yes	No
Hospira	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	071561-001	Apr 11, 1988		DISCN	No	No
Hospira	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	071560-001	Apr 11, 1988		DISCN	No	No

Expired US Patents for VINCRISTINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	ONCOVIN	vincristine sulfate	INJECTABLE;INJECTION	014103-003	Mar 7, 1984	4,619,935
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
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	6,723,338
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	5,814,335

Market Dynamics and Financial Trajectory for Vincristine Sulfate

Last updated: July 28, 2025

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Introduction

Vincristine sulfate, a critical chemotherapeutic agent derived from the periwinkle plant Catharanthus roseus, remains a cornerstone in oncology treatment protocols. As a member of the vinca alkaloid class, it primarily disrupts microtubule formation, leading to cell cycle arrest in metaphase. Despite the advent of targeted therapies and immunotherapies, vincristine sulfate's clinical relevance persists, underpinning a complex market landscape influenced by patent statuses, regulatory processes, and evolving treatment paradigms. This report delineates the current market dynamics and projects the financial trajectory of vincristine sulfate within the global pharmaceutical ecosystem.

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Market Overview and Size

The global vincristine sulfate market, estimated to be valued at approximately USD 300 million in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4-6% over the next five years. These estimates, extrapolated from industry reports and market analytics, reflect steady demand driven by its continued role in leukemia, lymphoma, and other malignancies [1]. The dominance of established formulations combined with ongoing procurement by hospitals and oncology centers sustains the market size.

Factors underpinning this valuation include the drug's widespread approval, incremental growth in cancer incidence rates, and the robust pipeline of combinatorial regimens integrating vincristine sulfate. Though newer therapies threaten to encroach upon the market, vincristine's cost-effectiveness and longstanding safety profile maintain its clinical prominence.

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Market Drivers

1. Prevalence of Hematological Cancers and Solid Tumors

Leukemia (notably acute lymphoblastic leukemia) and non-Hodgkin lymphoma comprise the primary indications for vincristine sulfate. The rising global incidence of these cancers fuels consistent demand for chemotherapeutic agents, bolstering market stability [2].

2. Established Clinical Efficacy and Treatment Protocols

Vincristine remains a pivotal agent in multi-drug chemotherapy regimens, including CHOP for lymphoma and hyper-CVAD for leukemia. Its integration into standardized treatment protocols secures ongoing procurement, especially in regions with limited access to novel therapies.

3. Cost-effectiveness and Reimbursement Policies

Compared to targeted biologics and immunotherapies, vincristine's lower manufacturing costs translate into favorable pricing, supporting utilization in cost-sensitive healthcare systems, particularly in Asia, Africa, and Latin America [3].

4. Regulatory Approvals and Patent Expiry

The expiration of patents for branded formulations has facilitated market entry by generic manufacturers, increasing supply and reducing prices. This trend enhances accessibility, especially in emerging markets.

5. Increasing Research into Combination Therapies

Ongoing clinical trials exploring vincristine in novel combinatorial treatments—for instance, with monoclonal antibodies or targeted small molecules—potentially expand its indications, sustaining demand.

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Market Challenges

1. Competition from Targeted and Immunotherapies

The rise of targeted agents such as blinatumomab, CAR-T cell therapies, and immune checkpoint inhibitors has begun to supplant traditional chemotherapies in certain indications, notably relapsed/refractory leukemia. These newer modalities often demonstrate superior efficacy but come with higher costs and complex logistics.

2. Toxicity Profile and Side Effects

Vincristine's neurotoxicity limits dosage escalation and can impair quality of life, prompting clinicians to seek safer alternatives. Increased awareness of adverse events fosters cautious use and may influence prescribing patterns.

3. Manufacturing and Supply Chain Constraints

Extracting vincristine sulfate involves complex biofermentation processes, sometimes hampered by raw material variability. Any disruptions can impact supply stability.

4. Regulatory Hurdles

Different jurisdictions impose stringent regulations on manufacturing standards and drug approvals, especially for biosimilars and generics, which could delay market access.

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Competitive Landscape

The landscape comprises several key players including Pfizer, Sandoz, Teva Pharmaceuticals, and Hospira, many offering generic formulations to capitalize on patent expirations [4]. The competitive environment is characterized by high-volume, low-margin dynamics, emphasizing cost leadership and supply reliability.

Recent entry of biosimilars and the development of novel formulations—such as liposomal or sustained-release variants—aim to improve pharmacokinetics and reduce neurotoxicity. However, regulatory pathways for biosimilars remain complex, potentially delaying widespread adoption.

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Regulatory and Patent Considerations

The original patents for vincristine sulfate formulations have long expired, fostering the proliferation of generics. Regulatory agencies like the FDA and EMA have established consistent pathways for approval of bioequivalent generics, accelerating market penetration. As patents for newer formulations and delivery mechanisms extend, exclusive manufacturing rights may temporarily hinder competition.

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Financial Projections and Investment Outlook

The financial trajectory of vincristine sulfate appears resilient, underpinned by consistent clinical demand and expanding healthcare infrastructure in developing economies. The global market's annual growth rate is expected to hover around 4-6%, with regional variations reflecting healthcare expenditure, cancer prevalence, and regulatory environment.

Investors and manufacturers should monitor key factors impacting the market:

• The pace of adoption of combination therapies and targeted agents.
• Cost reduction through process innovation.
• Regulatory approval rates for biosimilars and generic versions.
• R&D investments in novel formulations with improved safety profiles.

In emerging markets, government healthcare reforms and increased oncology center investments further augment growth prospects. Conversely, the high costs associated with next-generation therapies may pressure traditional chemotherapeutic markets.

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Future Outlook: Key Trends and Opportunities

1. Biosimilar and Generic Expansion

Growing acceptance of biosimilars offers an avenue for cost reductions, increasing access in resource-limited settings.

2. Formulation Innovations

Research into liposomal vincristine and conjugates aims to enhance targeting, minimize toxicity, and extend patent life potential, opening new revenue streams.

3. Integration into Multi-modal Oncology Regimens

Standardizing vincristine within emerging combination therapies sustains its relevance amid evolving personalized medicine approaches.

4. Digital Monitoring and Supply Chain Optimization

Adopting digital tools for inventory management and quality control could mitigate manufacturing disruptions, ensuring consistent supply.

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Conclusion

Vincristine sulfate maintains a vital role in oncology despite evolving therapeutic landscapes. Market stability hinges on its integration within combination regimens, generics proliferation, and ongoing formulation innovations. While competition from targeted therapies presents challenges, the drug's cost-effectiveness and established clinical track record secure its position, particularly in low-to-middle-income economies.

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Key Takeaways

• The global vincristine sulfate market is projected to grow modestly at 4-6% CAGR, driven by cancer prevalence and generics expansion.
• Patent expiry for original formulations has increased market competition, lowering prices and boosting accessibility.
• Advances in drug formulations and research into novel delivery methods could rejuvenate demand and extend market lifespan.
• Competition from targeted therapies poses a challenge; however, cost-effective chemotherapeutics retain a vital niche.
• Strategic focus on biosimilars, formulation innovation, and supply chain robustness will underpin future growth.

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FAQs

1. What primarily drives demand for vincristine sulfate globally?
   The ongoing need for effective chemotherapy in leukemia, lymphoma, and other cancers sustains demand, especially where cost considerations are paramount.

2. How does patent expiration influence vincristine sulfate markets?
   It enables the proliferation of generics, reduces prices, and increases availability, particularly in developing regions.

3. What are the main challenges facing vincristine sulfate market growth?
   Competition from targeted therapies, toxicity concerns, supply chain complexities, and regulatory hurdles.

4. Are there any recent innovations in vincristine formulations?
   Liposomal encapsulation and conjugate development aim to enhance targeting and reduce side effects, with ongoing clinical evaluations.

5. What is the outlook for vincristine sulfate in the context of emerging cancer therapies?
   While targeted therapies are expanding, vincristine's role persists as a cost-effective, foundational agent—its market enduring through formulation improvements and combination regimens.

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References

[1] MarketWatch. “Vincristine Sulfate Market Size, Share & Trends Analysis Report,” 2022.
[2] Globocan. “Cancer Incidence and Mortality Worldwide,” 2022.
[3] WHO. “Essential Medicines List,” 2021.
[4] Persistence Market Research. “Generic Oncology Drugs Market Overview,” 2022.