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, Ingenus Pharms Llc, Meitheal, MSN, Navinta Llc, Norvium Bioscience, and Penn Life, 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:	106
Clinical Trials:	231
Patent Applications:	5,399
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
Ruijin Hospital	N/A
First Affiliated Hospital Xi'an Jiaotong University	N/A
Children's Discovery Institute	Phase 1

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
Accord Hlthcare	CARMUSTINE	carmustine	POWDER;INTRAVENOUS	215000-002	May 16, 2022		DISCN	Yes	No
Accord Hlthcare	CARMUSTINE	carmustine	POWDER;INTRAVENOUS	215000-001	May 16, 2022		DISCN	Yes	No
Alembic	CARMUSTINE	carmustine	INJECTABLE;INJECTION	215730-001	Oct 20, 2023	AP	RX	No	No
Penn Life	CARMUSTINE	carmustine	INJECTABLE;INJECTION	209278-001	Apr 2, 2019	AP	RX	No	No
Amneal	CARMUSTINE	carmustine	INJECTABLE;INJECTION	211229-001	Oct 16, 2018	AP	RX	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	4,757,128
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	5,179,189
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	4,789,724

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/004326 Carmustine 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

CARMUSTINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carmustine

Market Overview

The carmustine market is poised for steady growth, driven by several key factors. Predicted to grow at a compound annual growth rate (CAGR) of 2.84% from 2024 to 2034, the market is expected to reach USD 1.03 billion by 2034, up from USD 0.78 billion in 2024[1].

Market Drivers

Several drivers are propelling the growth of the carmustine market:

Increasing Cancer Prevalence

The rising incidence of cancer, particularly in regions like North America and Europe, is a significant driver. Cancer treatments often involve chemotherapy, and carmustine is a crucial component in these regimens[1].

Technological Advancements

Advancements in biotechnology and pharmaceuticals are enhancing the efficacy and safety of carmustine. This includes the development of biosimilars, which are gaining traction due to their cost-effectiveness and similar therapeutic profiles to branded drugs[1].

Supportive Legislative Frameworks

Government initiatives and healthcare reforms are promoting the use of biosimilars, which in turn is driving the demand for carmustine. These policies aim to reduce healthcare costs while maintaining treatment quality[1].

Strategic Partnerships

Collaborations among pharmaceutical companies, research institutions, and healthcare providers are fostering innovation and expanding market reach. These partnerships often lead to better distribution channels and increased accessibility of carmustine[1].

Market Restraints

Despite the growth drivers, there are several restraints that could impact the market:

Patent Expirations

The expiration of patents for branded carmustine products can lead to increased competition from generic and biosimilar versions. While this can drive market growth by increasing accessibility, it also poses challenges for branded product manufacturers[1].

Regulatory Hurdles

Stringent regulatory requirements and the need for extensive clinical trials can slow down the approval and launch of new carmustine products. This can limit the entry of new players into the market[4].

Regional Market Analysis

The carmustine market is segmented into several key regions, each with its own dynamics:

North America

North America dominates the carmustine market, accounting for more than 47% of the market share. High cancer prevalence, technological advancements, and significant healthcare expenditure in the United States and Canada are key factors driving this region's growth[1].

Europe

Europe is another significant market for carmustine, driven by the increasing incidence of cancer and government initiatives promoting the use of biosimilars. Established pharmaceutical companies in the region are also focusing on biosimilar production, further boosting the market[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Factors such as increasing cancer cases, rising healthcare spending, supportive government policies, and a growing elderly population are contributing to this growth[1].

Financial Trajectory

The financial trajectory of the carmustine market is characterized by steady growth:

Market Size and Forecast

The market is projected to grow from USD 0.78 billion in 2024 to USD 1.03 billion by 2034, with a CAGR of 2.84% during this period[1].

Revenue Share and Growth Rate

The market revenue share and growth rate are expected to be stable, with North America leading in terms of revenue generation. The growth rate is influenced by the increasing demand for carmustine in various therapeutic applications[1].

Key Market Players

The carmustine market is dominated by a few large companies:

Amgen

Amgen is one of the leading players in the carmustine market, known for its innovative pharmaceutical products and strong distribution network[1].

SANDOZ INC

SANDOZ INC, a Novartis division, is another major player, focusing on the development and marketing of biosimilars, including carmustine[1].

Teva Pharmaceutical

Teva Pharmaceutical is also a significant player, with a broad portfolio of generic and branded pharmaceuticals, including carmustine[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the carmustine market:

Supply Chain Disruptions

The pandemic caused disruptions in the supply chain, affecting the production and distribution of carmustine. However, these disruptions were largely temporary and have been mitigated over time[4].

Increased Demand

On the other hand, the pandemic highlighted the importance of cancer treatments, leading to an increased focus on chemotherapy agents like carmustine. This increased demand has contributed to the market's growth[4].

Pricing Trends and Analysis

Pricing trends in the carmustine market are influenced by several factors:

Cost-Effectiveness

Biosimilars are becoming increasingly popular due to their cost-effectiveness compared to branded products. This trend is expected to continue, driving down the average cost of carmustine treatments[1].

Regulatory Influence

Government policies and regulatory frameworks also play a role in pricing. For instance, initiatives to reduce healthcare costs can lead to lower prices for carmustine products[1].

Clinical and Therapeutic Applications

Carmustine has several clinical and therapeutic applications:

Cancer Treatment

Carmustine is primarily used in the treatment of various types of cancer, including brain tumors, lymphomas, and multiple myeloma. Its efficacy in these applications is a key driver of market demand[3].

Bone Marrow Transplants

It is also used in bone marrow transplants to condition the bone marrow before transplantation. This application is critical in ensuring the success of such procedures[1].

Future Outlook and Opportunities

The future outlook for the carmustine market is promising, with several opportunities on the horizon:

Emerging Markets

The Asia Pacific region, in particular, offers significant growth opportunities due to its large population, increasing healthcare spending, and supportive government policies[1].

Technological Advancements

Continued advancements in biotechnology and pharmaceuticals will enhance the efficacy and safety of carmustine, potentially expanding its therapeutic applications[1].

Strategic Collaborations

Strategic partnerships and collaborations among industry players are expected to drive innovation and market growth. These partnerships can lead to better distribution channels and increased accessibility of carmustine[1].

Key Takeaways

• The carmustine market is projected to grow at a CAGR of 2.84% from 2024 to 2034.
• North America dominates the market, driven by high cancer prevalence and technological advancements.
• The Asia Pacific region is expected to be the fastest-growing segment.
• Key players include Amgen, SANDOZ INC, and Teva Pharmaceutical.
• The market is driven by increasing demand for cancer treatments, technological advancements, and supportive legislative frameworks.

FAQs

1. What is the projected CAGR of the carmustine market from 2024 to 2034?

The carmustine market is predicted to grow at a CAGR of 2.84% from 2024 to 2034[1].

2. Which region dominates the carmustine market?

North America dominates the carmustine market, accounting for more than 47% of the market share[1].

3. What are the key drivers of the carmustine market?

Key drivers include increasing cancer prevalence, technological advancements, supportive legislative frameworks, and strategic partnerships[1].

4. How has the COVID-19 pandemic impacted the carmustine market?

The pandemic caused temporary supply chain disruptions but also highlighted the importance of cancer treatments, leading to increased demand for carmustine[4].

5. What are the primary therapeutic applications of carmustine?

Carmustine is primarily used in the treatment of various types of cancer and in bone marrow transplants[1].

Sources:

1. We Market Research - Global Carmustine Market Size, Emerging Trends, Growth...
2. CMS - Evaluation of the Medicare Replacement Drug Demonstration
3. Kintara Therapeutics - United States Securities and Exchange Commission - Form 10-K
4. Cognitive Market Research - Global Carmustine Market Report 2024 Edition
5. Absolute Reports - Global Carmustine Injection Market - Healthcare