Dexrazoxane hydrochloride - Generic Drug Details

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

Dexrazoxane hydrochloride is the generic ingredient in three branded drugs marketed by Eugia Pharma, Gland, Hikma, Clinigen, and Pfizer, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for dexrazoxane hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	58
Patent Applications:	828
What excipients (inactive ingredients) are in dexrazoxane hydrochloride?	dexrazoxane hydrochloride excipients list
DailyMed Link:	dexrazoxane hydrochloride at DailyMed

Recent Clinical Trials for dexrazoxane hydrochloride

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

Sponsor	Phase
Ain Shams University	Phase 2/Phase 3
Polish Medical Research Agency	Phase 3
Maria Sklodowska-Curie National Research Institute of Oncology	Phase 3

See all dexrazoxane hydrochloride clinical trials

Pharmacology for dexrazoxane hydrochloride

Drug Class

Cytoprotective Agent

Medical Subject Heading (MeSH) Categories for dexrazoxane hydrochloride

Antineoplastic Agents

Cardiotonic Agents

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dexrazoxane hydrochloride

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for dexrazoxane hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	207321-001	Nov 28, 2016	AP	RX	No	No
Hikma	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	076068-001	Sep 28, 2004	AP	RX	No	No
Eugia Pharma	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	200752-001	Oct 19, 2011	AP	RX	No	Yes
Clinigen	TOTECT	dexrazoxane hydrochloride	INJECTABLE;INJECTION	022025-001	Sep 6, 2007		DISCN	Yes	No
Pfizer	ZINECARD	dexrazoxane hydrochloride	INJECTABLE;INJECTION	020212-002	May 26, 1995		DISCN	Yes	No
Gland	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	207321-002	Dec 16, 2019	AP	RX	No	No

Expired US Patents for dexrazoxane hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZINECARD	dexrazoxane hydrochloride	INJECTABLE;INJECTION	020212-002	May 26, 1995
Clinigen	TOTECT	dexrazoxane hydrochloride	INJECTABLE;INJECTION	022025-001	Sep 6, 2007
Pfizer	ZINECARD	dexrazoxane hydrochloride	INJECTABLE;INJECTION	020212-002	May 26, 1995
Pfizer	ZINECARD	dexrazoxane hydrochloride	INJECTABLE;INJECTION	020212-002	May 26, 1995
Pfizer	ZINECARD	dexrazoxane hydrochloride	INJECTABLE;INJECTION	020212-001	May 26, 1995
Pfizer	ZINECARD	dexrazoxane hydrochloride	INJECTABLE;INJECTION	020212-001	May 26, 1995

Dexrazoxane hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dexrazoxane Hydrochloride

Introduction to Dexrazoxane Hydrochloride

Dexrazoxane hydrochloride is a cardioprotective drug that plays a crucial role in protecting the heart from the cardiotoxic adverse effects of chemotherapeutic agents, particularly anthracyclines such as doxorubicin and daunorubicin. It is approved by the US FDA for the prevention of cardiomyopathy in adults and children aged 0 to 16 years undergoing anthracycline treatment[4][5].

Market Drivers

Increasing Prevalence of Cancer

The global rise in cancer cases is a significant driver for the dexrazoxane market. As the number of cancer patients increases, so does the use of anthracyclines, which in turn increases the demand for dexrazoxane to mitigate the cardiotoxic effects of these chemotherapy agents[1][4].

Advances in Healthcare

Advancements in healthcare, particularly in oncology, have led to an increased adoption of dexrazoxane in clinical practice. This shift towards using dexrazoxane is driven by its efficacy in reducing cardiotoxicity associated with anthracycline therapy, thereby improving patient outcomes[1][4].

Regulatory Approvals and Market Expansion

Key regulatory approvals and market launches have also driven the growth of the dexrazoxane market. For instance, Hikma Pharmaceuticals launched a generic version of dexrazoxane for injections in 2018, and Cumberland Pharmaceuticals initiated the promotion of Totect® (dexrazoxane hydrochloride) in the US in 2017[1][2].

Market Segmentation

By Product Type

The dexrazoxane market is segmented into two primary product types: 250mg and 500mg. These different dosages cater to various patient needs and treatment protocols[1][4].

By End User

The market is segmented by end users into hospitals and drugstores. Hospitals are expected to have the largest CAGR during the forecast period due to their direct involvement in cancer treatment and the presence of in-house pharmacies[1][4].

Regional Analysis

Global Market Distribution

The dexrazoxane market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe hold significant shares due to the presence of advanced cancer treatment institutions and well-established healthcare facilities[1][4].

Emerging Markets

Latin America and Asia Pacific regions are predicted to exhibit vital growth during the forecast period. Government initiatives to improve healthcare infrastructure in countries like China and India are expected to contribute significantly to the expansion of the dexrazoxane market[1][4].

Financial Trajectory

Market Size and Forecast

The global dexrazoxane market was valued at a significant amount in 2022 and is anticipated to grow at a substantial CAGR over the forecast period (2023-2029 or 2031). The market is expected to reach a higher value by the end of the forecast period, driven by the increasing demand for cardioprotective agents in oncology[3][4].

Revenue and Growth Projections

The market's financial trajectory is positive, with a significant increase in revenue projected due to the rising incidence of cancer and the consequent increase in the use of anthracyclines. The CAGR for the dexrazoxane market is expected to be high, reflecting the growing need for this drug in clinical settings[1][3].

Challenges and Opportunities

Side Effects and Dosage Concerns

Despite the growth drivers, the market faces challenges such as high dosages leading to side effects, which can hamper market growth. However, ongoing research and advancements in formulation and delivery methods are expected to mitigate these issues[4].

Competitive Landscape

The dexrazoxane market is characterized by a competitive landscape with key players such as Hikma Pharmaceuticals, Cumberland Pharmaceuticals, and Clinigen. These companies are focusing on organic and inorganic growth strategies, including product launches, acquisitions, and partnerships, to expand their market share[1][2][4].

Key Players and Market Strategies

Product Launches and Acquisitions

Companies like Cumberland Pharmaceuticals have launched promotional campaigns for their dexrazoxane products, such as Totect®, to increase market penetration. Clinigen's acquisition of Totect® in 2016 is another example of strategic moves to strengthen market presence[2][4].

SWOT Analysis

Key players in the market are analyzed through SWOT analysis, highlighting their strengths, weaknesses, opportunities, and threats. This analysis helps in understanding their market strategies and competitive positioning[4].

Conclusion

The dexrazoxane hydrochloride market is poised for significant growth driven by the increasing prevalence of cancer, advances in healthcare, and regulatory approvals. While challenges such as side effects exist, ongoing research and competitive strategies by key players are expected to drive the market forward.

Key Takeaways

• Increasing Cancer Prevalence: Rising cancer cases globally drive the demand for dexrazoxane.
• Healthcare Advances: Improved healthcare facilities and adoption of dexrazoxane in clinical practice boost market growth.
• Regulatory Approvals: Key launches and approvals, such as Totect® and generic versions, expand market reach.
• Regional Growth: North America and Europe lead, with Latin America and Asia Pacific showing promising growth.
• Financial Projections: Significant CAGR and revenue growth expected over the forecast period.

FAQs

What is dexrazoxane hydrochloride used for?

Dexrazoxane hydrochloride is used to protect the heart from cardiotoxic effects of chemotherapeutic agents like anthracyclines and to treat extravasation caused by intravenous anthracyclines[5].

Which regions dominate the dexrazoxane market?

North America and Europe currently hold significant shares of the global dexrazoxane market, with Latin America and Asia Pacific expected to show substantial growth[1][4].

What are the key drivers of the dexrazoxane market?

The key drivers include the increasing prevalence of cancer, advances in healthcare, and regulatory approvals for dexrazoxane products[1][4].

Which companies are major players in the dexrazoxane market?

Major players include Hikma Pharmaceuticals, Cumberland Pharmaceuticals, and Clinigen, among others[1][2][4].

What are the challenges facing the dexrazoxane market?

High dosages leading to side effects are a significant challenge, although ongoing research and advancements are expected to address these issues[4].

Sources

1. Research and Markets: Global Dexrazoxane Market Outlook 2028.
2. PR Newswire: Cumberland Pharmaceuticals Launches Promotion of Totect® in the US.
3. Valuates Reports: Global Dexrazoxane Market Research Report 2023.
4. The Insight Partners: Dexrazoxane Market Key Players Analysis 2031.
5. National Cancer Institute: Dexrazoxane Hydrochloride.