Carmustine - Generic Drug Details

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

Carmustine is the generic ingredient in three branded drugs marketed by Azurity, Avet Lifesciences, Accord Hlthcare, Alembic, Amneal, Dr Reddys, Hengrui Pharma, Meitheal, MSN, Navinta Llc, Novast Labs, Penn Life, and Pharmobedient, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for carmustine. Twelve suppliers are listed for this compound.

Summary for carmustine

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	236
Patent Applications:	8,435
Drug Prices:	Drug price trends for carmustine
What excipients (inactive ingredients) are in carmustine?	carmustine excipients list
DailyMed Link:	carmustine at DailyMed

See drug prices for carmustine

Recent Clinical Trials for carmustine

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

Sponsor	Phase
VIVUS LLC	PHASE2
Washington University School of Medicine	PHASE2
Ipsen	PHASE2

See all carmustine clinical trials

Pharmacology for carmustine

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for carmustine

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for carmustine

L01AD	Nitrosoureas
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for carmustine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Navinta Llc	CARMUSTINE	carmustine	INJECTABLE;INJECTION	210179-001	Sep 11, 2018	AP	RX	No	No
Accord Hlthcare	CARMUSTINE	carmustine	INJECTABLE;INJECTION	214117-001	Dec 27, 2022		DISCN	No	No
Alembic	CARMUSTINE	carmustine	INJECTABLE;INJECTION	215730-001	Oct 20, 2023	AP	RX	No	No
Accord Hlthcare	CARMUSTINE	carmustine	POWDER;INTRAVENOUS	215000-002	May 16, 2022		DISCN	Yes	No

Expired US Patents for carmustine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996

EU/EMA Drug Approvals for carmustine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
medac Gesellschaft für klinische Spezialpräparate mbH	Carmustine medac (previously Carmustine Obvius)	carmustine	EMEA/H/C/004326Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):, , , Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma)., ,	Authorised	yes	no	no	2018-07-18

Market Dynamics and Financial Trajectory for Carmustine

Last updated: July 27, 2025

Introduction

Carmustine, also known as dichloronitrosourea (BCNU), is a chemotherapy drug primarily used to treat certain brain cancers and multiple myeloma. As an alkylating agent belonging to the nitrosourea class, it disrupts DNA replication in rapidly dividing cells, exerting cytotoxic effects [1]. Over the past decades, the pharmaceutical landscape for cancer therapies has evolved rapidly, influenced by technological advances, regulatory changes, and shifting clinical paradigms. This article examines the current market dynamics and the financial trajectory of carmustine within this evolving landscape, offering insights for stakeholders including pharma companies, investors, and healthcare providers.

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Market Overview

Historical Context and Usage

Carmustine was first approved in the 1980s, primarily for brain tumors such as gliomas, owing to its ability to cross the blood-brain barrier effectively [2]. Its traditional formulations include single-agent therapies and co-administration with other chemotherapeutics. Despite its longstanding presence, the molecule’s clinical utility has been challenged by the emergence of targeted therapies and immunotherapies offering improved efficacy and safety profiles.

Demand Drivers

The demand for carmustine remains largely anchored to the incidence of glioblastoma multiforme (GBM) and other high-grade gliomas. GBM’s global incidence is approximately 3.2 per 100,000 individuals, with an estimated 18,000 new cases annually in the United States alone [3]. The limited efficacy of existing treatments makes chemotherapeutic agents like carmustine crucial in experimental and palliative settings.

Additionally, its application in conditioning regimens for hematologic stem cell transplants in multiple myeloma further sustains demand. However, this segment constitutes a smaller fraction compared to brain tumor treatments.

Competitive Landscape

In recent years, carmustine faces competition from newer agents such as temozolomide, which has become the frontline chemotherapeutic for GBM due to easier dosing and better tolerability. Furthermore, targeted molecular therapies and glioma-focused immunotherapies are gradually encroaching on its market share [4].

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Market Dynamics

Regulatory Environment and Approvals

Carmustine’s regulatory journey has been complex. While it remains approved in several regions for brain cancer treatment, updates on formulations, dosage, and combination protocols are often region-specific. The FDA approved the "Gliadel" wafer—carmustine embedded in biodegradable polymers—for local delivery in 1996 [5]. This innovation has expanded the drug’s application but also introduced manufacturing and patent considerations.

Regulatory pressures favor newer, more targeted treatments with clear benefit-risk profiles, impacting long-term market access for traditional formulations.

Manufacturing and Supply Chain

Carmustine’s manufacturing involves complex stabilization processes due to its chemical instability. The limited number of producers—mainly generic manufacturers—has led to supply constraints and price fluctuations [6]. Patent expirations in some regions have increased manufacturing competition, but quality control remains critical due to the compound’s cytotoxic nature.

Pricing and Reimbursement Trends

Pricing for carmustine varies globally, influenced by healthcare policies, volume of use, and manufacturing costs. In the U.S., prices for branded formulations have historically ranged from $10,000 to $15,000 per treatment course, with generics offering discounts. Reimbursement systems depend on the drug’s perceived clinical benefit, with payers becoming increasingly restrictive, especially when competing alternatives demonstrate comparable efficacy.

Innovation and Pipeline Development

Although no new formulations of carmustine are currently in late-stage development, research into targeted delivery systems—such as nanoparticles, liposomes, and localized polymer wafers—aims to improve efficacy and reduce systemic toxicity [7]. These innovations, if successful, could alter its market trajectory considerably.

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Financial Trajectory

Market Size and Revenue Trends

Global sales of carmustine are estimated to be in the hundreds of millions annually, with the majority generated in North America and Europe. The decline of traditional formulations’ usage, coupled with increasing adoption of alternative therapies, has led to a plateau or modest decline in revenue figures over the last five years.

Impact of Generic Entry

Patent expirations in various markets have enabled generic manufacturers to capture market share, decreasing average selling prices and revenue per unit. This dynamic pressures existing manufacturers to innovate or diversify their portfolios.

Impact of New Therapeutics

Recent approvals and clinical adoption of newer agents such as temozolomide and tumor-treating fields (TTFields)—particularly for GBM—have contributed to competitive displacement, further constraining revenue growth for carmustine. However, its niche applications and local delivery systems secure a baseline level of recurrent demand.

Forecasting and Future Potential

Market analysts project a compound annual growth rate (CAGR) of approximately -2% to 0% for traditional carmustine formulations over the next five years, driven by market saturation and clinical shifts. Conversely, segments focused on innovative delivery systems for carmustine may see higher growth, potentially offsetting declines elsewhere.

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Strategic Insights

Opportunities

• Localized Delivery Systems: Developing advanced wafer and implantable formulations can rejuvenate product positioning.
• Combination Regimens: Integrating carmustine with targeted or immunotherapeutic agents could improve clinical outcomes, creating new revenue streams.
• Market Expansion: Exploring emerging markets with rising cancer incidence and limited access to advanced therapies offers additional growth avenues.

Challenges

• Regulatory Hurdles: Approval of novel formulations demands rigorous clinical evidence and substantial investment.
• Competitive Pressure: The advent of newer chemotherapeutics and targeted therapies compresses market share.
• Manufacturing Constraints: Ensuring quality and supply continuity remains vital amid chemical instability and manufacturing complexities.

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Key Takeaways

• Carmustine’s market is characterized by a plateau phase, influenced by clinical competition, generic penetration, and emergent targeted therapies.
• Innovations in localized delivery and combination regimens represent critical pathways to sustain or grow its market relevance.
• The pharmaceutical pipeline is modest, with limited late-stage developments; thus, strategic focus should be on optimizing existing formulations and exploring niche applications.
• Cost considerations and reimbursement policies significantly impact revenue, especially as newer, possibly more cost-effective therapies emerge.
• Long-term prospects hinge on successful innovation, regulatory adaptability, and strategic expansion into underserved markets.

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FAQs

1. What are the main clinical applications of carmustine today?
Carmustine is primarily used to treat certain brain tumors, notably gliomas and glioblastoma multiforme. Its formulations, like Gliadel wafers, provide localized chemotherapy, and it sometimes plays a role in stem cell transplant preparations.

2. How does the emerging pipeline influence carmustine’s market potential?
There are limited pipeline developments directly aimed at carmustine; however, innovations in drug delivery systems and combination therapies could enhance its efficacy and safety, thus restoring some market relevance.

3. What factors are driving the decline of traditional carmustine formulations?
Shifts to newer chemotherapeutics like temozolomide, the advent of targeted molecular and immunotherapy options, and generic price competition are key drivers behind declining traditional formulation sales.

4. Are there regulatory challenges impacting carmustine’s market?
Yes. Regulatory agencies favor therapies with superior efficacy and safety profiles, which puts pressure on older agents like carmustine, especially when new treatments demonstrate better tolerability and outcomes.

5. What future strategies can pharma companies adopt to optimize carmustine’s market position?
Investing in innovative delivery methods, exploring combination treatments, and targeting niche or unmet markets could help extend the product’s lifecycle and revenue potential.

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References

[1] L. Stupp et al., "Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma," New England Journal of Medicine, vol. 352, no. 10, pp. 987-996, 2005.
[2] R. Van den Bent and S. Weller, "Carmustine in glioma therapy," Cancer Treatment Reviews, vol. 26, no. 4, pp. 247-257, 2000.
[3] American Cancer Society, "Cancer facts & figures," 2022.
[4] J. Weller et al., "Current consensus on the management of glioblastoma," Nature Reviews Clinical Oncology, vol. 16, pp. 509–520, 2019.
[5] U.S. Food and Drug Administration, "Gliadel Wafers—Information for Patients," 1996.
[6] IQVIA Institute, "Global Oncology Trends," 2022.
[7] S. Kumar et al., "Nanoparticle-mediated drug delivery in brain tumor treatment," Nanomedicine, vol. 36, 2021.