Vincristine sulfate - Generic Drug Details

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

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:	46
Clinical Trials:	478
Patent Applications:	7,465
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
Medical College of Wisconsin	Phase 1
Children's Cancer Research Fund	Phase 1
University of Colorado, Denver	Phase 1

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
Fresenius Kabi Usa	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	076401-001	Oct 28, 2003		DISCN	No	No
Lilly	ONCOVIN	vincristine sulfate	INJECTABLE;INJECTION	014103-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Abraxis Pharm	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	070411-001	Sep 10, 1986		DISCN	No	No
Hospira	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	071559-001	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	7,247,316

Vincristine sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vincristine Sulfate

Introduction to Vincristine Sulfate

Vincristine sulfate is a chemotherapy medication belonging to the vinca alkaloid class, widely used in the treatment of various types of cancer, including leukemia, lymphoma, neuroblastoma, and Wilms tumor. Its mechanism of action involves disrupting microtubule dynamics, which are essential for cell division, thereby inhibiting the growth and proliferation of cancer cells[2].

Market Size and Growth

The global vincristine sulfate market is experiencing significant growth driven by several key factors. As of 2023, the market size was valued at USD 425 million and is projected to reach USD 775 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.7%[1].

Drivers of Market Growth

Increasing Cancer Incidence

The rising global incidence of cancer is a major driver for the vincristine sulfate market. With an aging population and lifestyle factors contributing to higher cancer rates, the demand for effective chemotherapeutic agents like vincristine sulfate is increasing. This surge in cancer cases fuels research and development efforts, leading to the exploration of new indications and formulations[4].

Growing Demand for Targeted Therapies

There is a growing demand for targeted therapies, and vincristine sulfate, particularly in its liposomal formulation, is a key player in this segment. The liposomal formulation, such as Marqibo, allows for higher doses and extended circulation in the bloodstream, enhancing its efficacy and safety profile[2].

Regulatory Support

Regulatory support from organizations like the FDA and EMA plays a crucial role in driving the market. The approval of new formulations and the enforcement of stringent quality standards, such as Good Manufacturing Practices (GMP), enhance consumer confidence and encourage pharmaceutical companies to invest in vincristine sulfate APIs[4].

Global Expansion of Healthcare Infrastructure

The expansion of healthcare infrastructure, especially in emerging markets, is increasing access to cancer treatment. Government initiatives, funding, and collaborations between governments, NGOs, and pharmaceutical companies are making essential drugs, including vincristine sulfate, more widely available[4].

Market Segmentation

By Product Type

The vincristine sulfate market is segmented by product type, with the primary focus on vincristine sulfate itself. However, the broader vinca alkaloid API market includes other products like vinblastine sulfate and vindesine. Each of these products has unique therapeutic profiles and is used in treating different types of cancers[4].

• Vincristine Sulfate: Primarily used in the treatment of childhood leukemia and certain lymphomas.
• Vinblastine Sulfate: Often prescribed for treating Hodgkin’s disease and testicular cancer.
• Vindesine: Recognized for its role in the treatment of acute lymphoblastic leukemia and as part of combination chemotherapy regimens.

By Geography

The market is also segmented geographically into regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. North America, particularly the United States, is a significant hub for pharmaceutical innovation and demand for vincristine sulfate due to favorable reimbursement scenarios and the presence of established pharmaceutical companies[4].

Financial Trajectory

The financial trajectory of the vincristine sulfate market is promising, with several indicators pointing to sustained growth:

• Market Size: Expected to grow from USD 425 million in 2023 to USD 775 million by 2032, at a CAGR of 6.7%[1].
• Revenue Streams: The market benefits from increasing demand for targeted therapies and the expansion of healthcare infrastructure globally.
• Investments: Pharmaceutical companies are investing heavily in research and development to improve formulations and expand indications for vincristine sulfate, which is expected to drive revenue growth[4].

Key Formulations and Innovations

Liposomal Formulation

The approval of the liposomal formulation of vincristine sulfate, known as Marqibo, has been a significant innovation. This formulation allows for higher doses and extended circulation in the bloodstream, making it more effective for treating adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) who have experienced relapses or whose disease has progressed after multiple treatments[2].

Pharmacokinetics and Administration

Understanding the pharmacokinetics of vincristine sulfate is crucial for optimizing its dosage and administration. The drug is administered via an intravenous (IV) route and is rapidly absorbed into the systemic circulation. It is primarily eliminated in the bile and feces, with a biphasic elimination half-life that varies among individuals based on factors such as age, body weight, and liver and renal function[2].

Challenges and Opportunities

Challenges

• Side Effects: Vincristine sulfate can cause significant side effects, including neurotoxicity, which can limit its use in some patients.
• Competition: The market faces competition from other chemotherapeutic agents and emerging targeted therapies.

Opportunities

• Emerging Markets: The expansion of healthcare infrastructure in emerging markets presents significant opportunities for growth.
• Research and Development: Continuous research into new formulations and indications can further enhance the market for vincristine sulfate.

Key Takeaways

• The global vincristine sulfate market is projected to grow significantly, driven by increasing cancer incidence, growing demand for targeted therapies, and regulatory support.
• The market is segmented by product type and geography, with North America being a key region.
• Innovations such as the liposomal formulation are enhancing the efficacy and safety of vincristine sulfate.
• Understanding pharmacokinetics is crucial for optimal administration and patient outcomes.

FAQs

Q: What is the primary use of vincristine sulfate in cancer treatment? A: Vincristine sulfate is primarily used to treat various types of cancer, including leukemia, lymphoma, neuroblastoma, and Wilms tumor, by disrupting microtubule dynamics and inhibiting cell division[2].

Q: What is the expected market size of vincristine sulfate by 2032? A: The global vincristine sulfate market is expected to reach USD 775 million by 2032, growing at a CAGR of 6.7% from 2023[1].

Q: What is the significance of the liposomal formulation of vincristine sulfate? A: The liposomal formulation, such as Marqibo, allows for higher doses and extended circulation in the bloodstream, enhancing the efficacy and safety profile of vincristine sulfate, particularly for treating adult patients with Philadelphia chromosome-negative ALL[2].

Q: Which regions are key drivers for the vincristine sulfate market? A: North America, particularly the United States, is a significant hub for pharmaceutical innovation and demand for vincristine sulfate. Other key regions include Europe, Asia-Pacific, Latin America, and the Middle East and Africa[4].

Q: What are the main drivers of the vincristine sulfate market growth? A: The main drivers include increasing cancer incidence, growing demand for targeted therapies, regulatory support, and the global expansion of healthcare infrastructure[4].

Sources

1. Dataintelo: Global Vincristine Sulfate Market Research Report 2032.
2. NCBI Bookshelf: Vincristine - StatPearls.
3. Wicz: Vincristine Sulfate Liposome Injection Drugs Market.
4. Verified Market Research: Vinca Alkaloid API Market Size, Scope, Growth and Forecast.
5. Market Research Intellect: Vincristine Sulfate Liposome Injection Market: Key Driver in the Fight Against Cancer.