Dacarbazine - Generic Drug Details

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

Dacarbazine is the generic ingredient in two branded drugs marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, and Bayer Hlthcare, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for dacarbazine. Three suppliers are listed for this compound.

Summary for dacarbazine

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	240
Patent Applications:	7,568
Drug Prices:	Drug price trends for dacarbazine
What excipients (inactive ingredients) are in dacarbazine?	dacarbazine excipients list
DailyMed Link:	dacarbazine at DailyMed

See drug prices for dacarbazine

Recent Clinical Trials for dacarbazine

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

Sponsor	Phase
Diwakar Davar	Phase 2
IDEAYA Biosciences	Phase 2/Phase 3
Federal Research Institute of Pediatric Hematology, Oncology and Immunology	Phase 3

See all dacarbazine clinical trials

Pharmacology for dacarbazine

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for dacarbazine

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for dacarbazine

L01AX	Other alkylating agents
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for dacarbazine

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	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075371-002	Aug 27, 1999	AP	RX	No	Yes
Hikma	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075812-001	Jun 15, 2001	AP	RX	No	No
Abraxis Pharm	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	070962-001	Aug 28, 1986		DISCN	No	No
Hospira	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075940-001	Oct 18, 2001	AP	RX	No	No
Meitheal	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075259-001	Sep 22, 2000	AP	RX	No	Yes

Dacarbazine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dacarbazine

Introduction to Dacarbazine

Dacarbazine, also known as DTIC, is a chemotherapy drug that has been a cornerstone in cancer treatment for several decades. It is particularly effective in treating malignant melanoma and Hodgkin's lymphoma by targeting rapidly dividing cancer cells and disrupting their growth.

Market Size and Growth

The global dacarbazine market is experiencing steady growth driven by several key factors. As of 2023, the market size was valued at approximately USD 100 million and is projected to reach around USD 150 million by 2032, indicating a significant increase in demand over the next decade[4].

Market Drivers

Prevalence of Cancer

The persistent and increasing prevalence of cancer, especially malignant melanoma and Hodgkin's lymphoma, fuels the demand for effective chemotherapy agents like dacarbazine. This ongoing need for cancer treatments is a primary driver of the market[3].

Efficacy in Specific Cancers

Dacarbazine's proven efficacy in treating specific types of cancer positions it as a first-line treatment and in combination therapies. Its ability to target rapidly dividing cells and its role in precision oncology further enhance its market demand[3].

Advancements in Precision Medicine

The evolving landscape of precision medicine and personalized oncology drives the adoption of dacarbazine. As treatments become more tailored to individual patient profiles, the importance of dacarbazine as a foundational element in treatment regimens increases[3].

Increased Cancer Awareness and Early Diagnosis

The growth in cancer awareness and early diagnosis contributes to an increased demand for effective treatments like dacarbazine. Early detection often leads to a higher likelihood of successful treatment, which in turn boosts the market for chemotherapy drugs[3].

Financial Trajectory

Revenue Projections

The global dacarbazine market is expected to grow at a significant rate, with revenue projections indicating a rise from USD 100 million in 2023 to around USD 150 million by 2032. This growth is driven by the increasing demand for cancer treatments and the expanding role of dacarbazine in precision oncology[4].

Capital and Operating Expenditures

For companies considering setting up a dacarbazine manufacturing plant, the financial trajectory involves substantial capital expenditures (CapEx) and operating expenditures (OpEx). The setup costs include investments in machinery, raw materials, infrastructure, and human resources. Operating expenses encompass ongoing costs such as utility requirements, packaging, transportation, and regulatory compliance[3].

Project Economics

The project economics for a dacarbazine manufacturing plant involve detailed analyses of income projections, taxation, depreciation, liquidity analysis, profitability analysis, payback period, net present value (NPV), and sensitivity analysis. These financial metrics help in assessing the viability and potential return on investment (ROI) for such a project[3].

Competitive Landscape

Comparison with Other Treatments

Dacarbazine is often compared with other chemotherapy agents in clinical trials to assess its efficacy and safety. For instance, a phase III trial compared trabectedin with dacarbazine in patients with advanced liposarcoma or leiomyosarcoma, showing that trabectedin resulted in a 45% reduction in the risk of disease progression or death compared to dacarbazine[2].

Combination Therapies

Dacarbazine is frequently used in combination with other drugs to enhance its efficacy. For example, a study combining dacarbazine with selumetinib showed improved progression-free survival compared to dacarbazine alone, highlighting the potential benefits of combination therapies[2].

Regulatory and Approval Processes

Setting up a dacarbazine manufacturing plant involves navigating through various regulatory procedures and obtaining necessary approvals. This includes compliance with quality assurance criteria, technical tests, and environmental impact assessments. The regulatory landscape is crucial for ensuring the safety and efficacy of the drug[3].

Challenges and Opportunities

Side Effects and Safety Profile

While dacarbazine is effective, it comes with a range of side effects, including nausea, diarrhea, and fatigue. Managing these side effects is a challenge that manufacturers and healthcare providers must address. However, the ongoing research and development in cancer therapies offer opportunities for improving the safety profile and delivery methods of dacarbazine[2][5].

Market Expansion and Geographic Distribution

The global nature of the dacarbazine market presents opportunities for expansion into new regions. Understanding regional market dynamics, regulatory requirements, and patient needs is essential for successful market penetration[3].

Key Takeaways

• Market Growth: The global dacarbazine market is projected to grow significantly, driven by the increasing prevalence of cancer and advancements in precision medicine.
• Financial Projections: Revenue is expected to rise from USD 100 million in 2023 to around USD 150 million by 2032.
• Competitive Landscape: Dacarbazine is often compared with other chemotherapy agents and is used in combination therapies to enhance efficacy.
• Regulatory Compliance: Setting up a manufacturing plant requires adherence to various regulatory procedures and approvals.
• Challenges and Opportunities: Managing side effects and expanding into new regions are key challenges and opportunities for the market.

FAQs

What is the primary use of dacarbazine in cancer treatment?

Dacarbazine is primarily used to treat malignant melanoma and Hodgkin's lymphoma by targeting rapidly dividing cancer cells and disrupting their growth.

How is the global dacarbazine market expected to grow?

The global dacarbazine market is expected to grow from approximately USD 100 million in 2023 to around USD 150 million by 2032.

What are the key drivers of the dacarbazine market?

The key drivers include the prevalence of cancer, efficacy in specific cancers, advancements in precision medicine, and increased cancer awareness and early diagnosis.

What are the common side effects of dacarbazine?

Common side effects include nausea, diarrhea, fatigue, and other gastrointestinal issues.

What regulatory steps are involved in setting up a dacarbazine manufacturing plant?

Setting up a manufacturing plant involves compliance with quality assurance criteria, technical tests, environmental impact assessments, and obtaining necessary regulatory approvals.

Sources

1. Market Research Reports: Global Dacarbazine Market Growth 2023-2029.
2. Science.gov: First-line dacarbazine chemotherapy: Topics by Science.gov.
3. IMARC Group: Dacarbazine Manufacturing Plant Report 2024: Setup & Cost.
4. Dataintelo: Dacarbazine Market Research Report 2032.
5. Pharmacy Times: Melanoma: Therapy Update.