Mitoxantrone hydrochloride - Generic Drug Details

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

Mitoxantrone hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Rising, and Emd Serono, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for mitoxantrone hydrochloride. Two suppliers are listed for this compound.

Summary for mitoxantrone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	8
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	380
Patent Applications:	7,311
What excipients (inactive ingredients) are in mitoxantrone hydrochloride?	mitoxantrone hydrochloride excipients list
DailyMed Link:	mitoxantrone hydrochloride at DailyMed

Recent Clinical Trials for mitoxantrone hydrochloride

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

Sponsor	Phase
Acute Leukemia French Association	Phase 2
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	N/A
CSPC Ouyi Pharmaceutical Co., Ltd.	N/A

See all mitoxantrone hydrochloride clinical trials

Pharmacology for mitoxantrone hydrochloride

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for mitoxantrone hydrochloride

Analgesics

Antineoplastic Agents

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mitoxantrone hydrochloride

L01DB	Anthracyclines and related substances
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for mitoxantrone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	077356-003	Apr 11, 2006	AP	RX	No	No
Meitheal	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	077356-002	Apr 11, 2006	AP	RX	No	No
Fresenius Kabi Usa	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	077496-001	Apr 11, 2006	AP	RX	No	No
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-003	Dec 23, 1987		DISCN	Yes	No

Expired US Patents for mitoxantrone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987	4,820,738
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987	4,138,415
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-003	Dec 23, 1987	4,820,738
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-002	Dec 23, 1987	4,820,738

Mitoxantrone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mitoxantrone Hydrochloride

Market Overview

Mitoxantrone hydrochloride, an anthracenedione chemotherapeutic agent, has been gaining significant traction in the pharmaceutical market due to its versatile applications in treating various diseases, including cancer and multiple sclerosis.

Market Size and Growth

The mitoxantrone market was valued at USD 15 billion in 2023 and is projected to reach USD 22.16 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Applications and Segments

Cancer Treatment

Mitoxantrone is widely used in cancer treatment, particularly for leukemia, breast cancer, and prostate cancer. Its mechanism of action involves suppressing the development of cancer cells by preventing DNA replication and repair. The drug's broad spectrum of antineoplastic activity against various malignancies makes it a key component in chemotherapy regimens[1].

Multiple Sclerosis

In the realm of autoimmune diseases, mitoxantrone is approved for treating secondary progressive multiple sclerosis (MS). Clinical trials have shown that it significantly reduces relapse rates and delays disability progression in MS patients. Its convenience of administration, requiring only once every three months, adds to its appeal and cost-effectiveness[3].

Geographical Distribution

The market for mitoxantrone is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique market dynamics influenced by local healthcare policies, patient demographics, and economic factors.

Key Players

The mitoxantrone market is dominated by several major pharmaceutical companies, including Pfizer, Novartis, Merck, Roche, GSK, Johnson & Johnson, Amgen, Eli Lilly, AbbVie, and Teva. These companies play a crucial role in driving market growth through continuous innovation, clinical research, and strategic partnerships[1][4].

Market Drivers

Clinical Research and Innovations

Ongoing clinical research exploring the potential of mitoxantrone in combination therapies and its application in autoimmune disorders is a significant driver of market growth. The drug's ability to cross the blood-brain barrier makes it particularly useful in treating neurological diseases and brain cancers[1].

Regulatory Approvals

Growing approvals for new indications and formulations of mitoxantrone are further boosting the market. Regulatory support and the increasing understanding of the drug's mechanism of action are key factors in its expanding use in oncology and autoimmune treatment sectors[1].

Personalized Medicine

The rising global incidence of cancer and advancements in personalized medicine are driving the demand for mitoxantrone-based therapies tailored to individual patient needs. This personalized approach enhances treatment efficacy and patient outcomes, contributing to market growth[1].

Market Restraints

Cardiotoxicity Concerns

One of the significant restraints on the long-term use of mitoxantrone is the concern over cardiotoxicity. The maximum cumulative dose recommended is 120 mg/m², limiting the duration of therapy to two to three years. This limitation can impact the drug's market potential and patient adherence[3].

Cost-Utility Analysis

While mitoxantrone is considered cost-effective for treating secondary progressive MS, its cost-utility ratios can be sensitive to acquisition and administration costs. For instance, a cost-utility analysis showed that mitoxantrone hydrochloride is likely to be cost-effective from an insurer's perspective but may not be as efficient when compared to other treatments like interferon beta-1b[2].

Financial Trajectory

Revenue Forecast

The mitoxantrone market is expected to witness substantial growth, with revenues projected to increase from USD 15 billion in 2023 to USD 22.16 billion by 2031. This growth is driven by the expanding use of the drug in various therapeutic areas and the increasing demand for effective cancer and MS treatments[1].

Cost of Treatment

The cost of treatment per patient and the number of patients likely to be treated are critical factors in determining the market value. For example, the potential market value of mitoxantrone, based on the cost of treatment per patient and the number of patients treated in the first year of introduction, was estimated to be around US$210 million[3].

Competitive Landscape

The competitive landscape of the mitoxantrone market is characterized by intense competition among major pharmaceutical companies. Porter’s five forces analysis highlights the competitive rivalry, bargaining power of suppliers and buyers, and the threat of new entrants and substitutes. The value chain analysis provides insights into the roles of various players in the market and the value generation processes[1].

Future Prospects

Ongoing Research and Partnerships

Continuous innovation in cancer therapy and supportive regulatory frameworks are expected to drive the market forward. Partnerships between academic institutions and pharmaceutical companies to extend clinical studies and explore new therapeutic applications will continue to support market expansion[1].

Emerging Markets

The Asia-Pacific region, in particular, is expected to contribute significantly to the market growth due to its large patient population and improving healthcare infrastructure. This region offers substantial opportunities for pharmaceutical companies to expand their market presence[1].

Key Takeaways

• The mitoxantrone market is projected to grow significantly, driven by its effectiveness in treating cancer and multiple sclerosis.
• Key drivers include ongoing clinical research, regulatory approvals, and advancements in personalized medicine.
• Major pharmaceutical companies are leading the market through innovation and strategic partnerships.
• Concerns over cardiotoxicity and cost-utility ratios are significant restraints.
• The market is expected to reach USD 22.16 billion by 2031, with substantial growth opportunities in emerging markets.

FAQs

What is the primary use of mitoxantrone hydrochloride?

Mitoxantrone hydrochloride is primarily used in the treatment of cancer, particularly leukemia, breast cancer, and prostate cancer, as well as in the treatment of multiple sclerosis.

What are the key drivers of the mitoxantrone market?

Key drivers include ongoing clinical research, regulatory approvals for new indications and formulations, advancements in personalized medicine, and the drug's ability to cross the blood-brain barrier.

Which companies are major players in the mitoxantrone market?

Major players include Pfizer, Novartis, Merck, Roche, GSK, Johnson & Johnson, Amgen, Eli Lilly, AbbVie, and Teva.

What are the geographical segments of the mitoxantrone market?

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa.

What are the potential restraints on the mitoxantrone market?

Significant restraints include concerns over cardiotoxicity, which limits the duration of therapy, and sensitive cost-utility ratios compared to other treatments.

How is the mitoxantrone market expected to grow in the future?

The market is expected to grow at a CAGR of 5% from 2024 to 2031, reaching USD 22.16 billion by 2031, driven by ongoing research, regulatory support, and expanding use in various therapeutic areas.

What is the significance of mitoxantrone in treating multiple sclerosis?

Mitoxantrone is one of the few drugs approved for treating secondary progressive MS, offering a significant reduction in relapse rates and delay in disability progression, making it a valuable treatment option for MS patients.

How does the cost-utility analysis impact the use of mitoxantrone?

Mitoxantrone hydrochloride is considered cost-effective from an insurer's perspective but may not be as efficient compared to other treatments like interferon beta-1b, influencing treatment choices based on cost and efficacy.

Sources

1. Market Research Intellect, "Mitoxantrone Market Size, Growth, Share | Analysis by 2031".
2. PubMed, "A cost-utility analysis of mitoxantrone hydrochloride and interferon beta-1b".
3. PubMed, "Evaluation of mitoxantrone for the treatment of multiple sclerosis".
4. Valuates Reports, "Global Mitoxantrone Hydrochloride Market Research Report 2024".