CARMUSTINE - Generic Drug Details

What are the generic sources for carmustine and what is the scope of freedom to operate?

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
Hengrui Pharma	CARMUSTINE	carmustine	INJECTABLE;INJECTION	211202-001	Mar 12, 2021		DISCN	No	No
Pharmobedient	CARMUSTINE	carmustine	INJECTABLE;INJECTION	215368-001	Mar 3, 2023		DISCN	No	No
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996		RX	Yes	Yes

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 (BCNU)

Last updated: January 13, 2026

Executive Summary

Carmustine, commercially known as BCNU, is an alkylating chemotherapeutic agent primarily used in the treatment of brain tumors, multiple myeloma, and Hodgkin’s lymphoma. Over the past decade, its market landscape has been influenced by evolving oncology treatment paradigms, regulatory pathways, and the emergence of novel therapies. This report examines the current market dynamics, financial trajectory, and future outlook for Carmustine, providing strategic insights for stakeholders.

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Overview of Carmustine (BCNU)

Parameter	Details
Generic Name	Carmustine
Brand Names	BiCNU (original), others vary by region
Drug Class	Nitrosourea alkylating agent
Indications	Brain tumors (gliomas, glioblastomas), multiple myeloma, Hodgkin’s lymphoma
Approval Date	FDA approval in 1977
Formulations	Intravenous, implantable wafers (Gliadel)

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Market into Context: Current Landscape

1. Therapeutic Role and Usage Trends

• Primary Indications:
  Carmustine is most prominently used in high-grade gliomas, especially glioblastoma multiforme (GBM). It is also utilized in conjunction with surgery and radiotherapy, as well as for systemic lymphoma and multiple myeloma.

• Administration Routes & Formulations:

  • Intravenous injection: Standard systemic therapy.
  • Gliadel wafers: Localized delivery for malignant gliomas, approved in 1996, reducing systemic toxicity.

• Treatment Paradigm Shift:
  The therapeutic landscape has shifted towards targeted therapies and immuno-oncology agents, reducing reliance on traditional chemotherapies like Carmustine. However, its niche remains vital especially in recurrent gliomas.

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2. Market Size and Revenue

Metric	2022 Data	2023 Projections	Notes
Global Market Size (Chemotherapy segment)	~$5.2 billion	Projected to reach ~$6.3 billion by 2028	CAGR ~3.5% (2023-2028)
Carmustine-specific Revenue	Estimated ~$150 million	Slight growth expected	Due to niche status and competing therapies
Market Share (Within Chemotherapy)	~2.9%	Stable, with potential decline	Dominated by platinum agents, taxanes, immunotherapies

Sources: Market Research Future [1], GlobalData [2].

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Market Drivers

Driver	Impact	Evidence
unmet medical needs in gliomas	Maintains Carmustine's relevance	Glioma treatments limited; Carmustine remains a standard option [3]
Advances in neurosurgical techniques	Increased wafer use	Use of Gliadel wafers in recurrent glioblastoma has grown [4]
Regulatory approvals for combination regimens	Extends use	Combinations with Temozolomide and radiotherapy in trials [5]
Increased prevalence of brain tumors	Growing patient pool	Globally, primary brain tumors estimated at 3.5 per 100,000 annually [6]

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Market Restraints

Restraint	Effect	Details
Emergence of targeted therapies and immunotherapies	Competition intensifies	Agents like Bevacizumab and pembrolizumab gaining ground [7]
Side-effect profile and toxicity	Limiting use	Myelosuppression, pulmonary toxicity; adverse events constrain usage [8]
Limited innovation and formulation development	Stagnation	Lack of new formulations may limit growth compared to newer agents

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Competitive Landscape

Competitors	Key Features	Market Positioning
Gliadel Wafers	Localized therapy, minimal systemic toxicity	Niche modality for gliomas
Temozolomide (TMZ)	Oral, preferred in glioma care	Dominant systemic agent
Novartis’ Lomustine (CCNU)	Similar nitrosourea class, oral dosing	Direct competitor for systemic use

Regulatory & Patent Status

• Patent Status: Expired; generic versions available globally.
• Regulatory Pathways: No recent approvals; existing formulations rely on off-patent distribution.

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Financial Trajectory Analysis

1. Revenue Trends (Historical & Forecasted)

Year	Revenue (USD million)	Comments
2017	~$130	Steady but modest growth
2018	~$135	Slight uptick, driven by glioma cases
2019	~$140	Market stabilization
2020	~$145	Pandemic effects limited
2021	~$148	Slight growth, emerging combination therapies
2022	~$150	Current estimate
2023-2028	CAGR ~1-2%	Marginal growth expected, stabilization or decline possible

2. Cost and Pricing Dynamics

Aspect	Details
Pricing Strategy	Off-patent, commodity pricing; regional variations
Manufacturing Cost	Low due to generic manufacturing, ~$0.50–$1 per dose
Pricing Trends	Stable, with slight reductions due to competition

3. Market Entry Barriers & Opportunities

Barrier	Effect	Mitigation Strategies
High clinical efficacy threshold	Limits lower-tier products	Focused innovation on formulations/delivery methods
Regulatory hurdles	Slow approval of new indications	Engage early with regulators, leverage existing approvals
Competition from newer agents	Market share erosion	Emphasize niche uses and combination regimens

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Future Outlook & Strategic Considerations

1. Innovation and Development Opportunities

• Novel Formulations:
  Encapsulation, nanoparticle delivery, or targeted wafer technologies could reduce toxicity and improve efficacy.

• Combination Therapies:
  Trials combining Carmustine with immune checkpoint inhibitors could rejuvenate its relevance.

• Repurposing & Fast-Track Approvals:
  New indications or delivery systems may benefit from accelerated regulatory pathways.

2. Regulatory & Policy Influences

• Reimbursement & Coverage Policies:
  Payer policies favor newer, targeted treatments, potentially impacting Carmustine's market penetration.

• Global Access & Equity:
  High affordability due to generics supports expanding access in low-income regions.

3. Competitive Dynamics

Element	Trends/Implications
Generic proliferation	Keeps prices low but limits revenue growth
Emergence of targeted agents	Replaces Carmustine in some indications
Extended survival benefits via combination therapies	May prolong Carmustine’s clinical relevance

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Key Takeaways

• Carmustine remains a niche chemotherapeutic agent with steady but modest revenue, primarily used for brain tumors and via Gliadel wafers.
• The market is characterized by low growth due to competition from targeted and immuno-oncology therapies, but niche applications preserve its relevance.
• Future growth hinges on innovations in drug delivery, combination regimens, and expansion into new indications.
• Market entry barriers are low for generics, but innovation-driven differentiation is critical for sustained market presence.
• Patient demand is influenced by the increasing prevalence of brain tumors and limited effective alternatives in specific settings.

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FAQs

1. What are the main disease indications for Carmustine?

Carmustine is primarily used to treat high-grade gliomas, especially glioblastoma multiforme, and also for certain hematological malignancies such as multiple myeloma and Hodgkin’s lymphoma.

2. How does Carmustine compare to newer therapies like Temozolomide?

Temozolomide has become the preferred systemic agent for gliomas due to oral administration, better tolerability, and proven survival benefits. Carmustine is mostly reserved for recurrent or specific cases, especially with localized wafers.

3. What are the main competitive threats to Carmustine’s market share?

Emerging targeted therapies, immunotherapies, and innovative delivery systems threaten Carmustine’s market position—especially in glioma management where newer options demonstrate improved outcomes.

4. Is Carmustine currently under patent protection?

No. The patent on Carmustine has expired; generic versions are widely available, which supports low pricing but limits revenue growth.

5. What prospects exist for revitalizing Carmustine’s market?

Potential opportunities include developing novel formulations, combination therapies with immunotherapies, and gaining approvals for new indications, potentially supported by early-phase clinical trials.

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References

[1] Market Research Future, “Global Chemotherapy Market Analysis,” 2022.
[2] GlobalData, “Oncology Market Forecasts,” 2023.
[3] Stupp et al., “Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma,” NEJM, 2005.
[4] Johnson et al., “Gliadel Wafers in Glioma Treatment: A Clinical Review,” Neuro-Oncology, 2014.
[5] ClinicalTrials.gov, “Ongoing Trials Combining Carmustine with Targeted Therapies,” 2023.
[6] International Agency for Research on Cancer, “Global Cancer Incidence,” 2021.
[7] Brown and Smith, “Immunotherapy in Brain Tumors,” Journal of Neuro-Oncology, 2020.
[8] Kumar et al., “Toxicity Profile of Carmustine,” Oncology Reviews, 2019.