DEXRAZOXANE HYDROCHLORIDE - Generic Drug Details

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

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

Seven suppliers are listed for this compound.

Summary for DEXRAZOXANE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	64
Patent Applications:	1,103
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
Cancer League of Colorado	PHASE2
University of Colorado, Denver	PHASE2
Children's Oncology Group	PHASE3

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
Eugia Pharma	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	200752-001	Oct 19, 2011	AP	RX	No	Yes
Pfizer	ZINECARD	dexrazoxane hydrochloride	INJECTABLE;INJECTION	020212-002	May 26, 1995		DISCN	Yes	No
Msn	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	216748-002	Mar 26, 2025	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

Market Dynamics and Financial Trajectory for Dexrazoxane Hydrochloride

Last updated: July 27, 2025

Introduction

Dexrazoxane hydrochloride, marketed under various brand names, is a critically important pharmaceutical agent primarily utilized as a cardioprotective agent during chemotherapy protocols involving anthracyclines such as doxorubicin or daunorubicin. Approved by regulatory agencies globally, the drug’s unique mechanism of action, targeted indications, and evolving market landscape influence its commercial trajectory. Understanding the market dynamics and financial outlook of dexrazoxane hydrochloride requires examining clinical demand, regulatory environment, competitive positioning, patent landscape, and emerging trends shaping its future.

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Clinical and Therapeutic Landscape

Dexrazoxane hydrochloride functions by chelating iron and preventing free radical formation, thus minimizing anthracycline-induced cardiotoxicity. Its primary indication involves patients undergoing chemotherapy for breast cancer, leukemia, and other malignancies where anthracyclines are employed. The clinical necessity for cardioprotection in oncology has driven consistent demand; however, the scope remains constrained by safety concerns, alternative therapies, and evolving clinical guidelines.

Recent advancements in oncology, such as targeted therapies and immunotherapies, influence the size and dynamics of the traditional chemotherapeutic market segment. Nonetheless, dexrazoxane retains indispensable value in patients at high risk for cardiotoxicity, especially in populations with significant cumulative anthracycline exposure [1].

Regulatory Environment and Approvals

Dexrazoxane is approved in multiple jurisdictions—including the United States, European Union, and Asia—though with varied indications, dosing guidelines, and safety warnings. For example, the U.S. FDA approved dexrazoxane in 1995 for preventing cardiomyopathy in patients receiving doxorubicin, but its usage has become more conservative due to concerns about secondary malignancies and myelosuppression [2].

Regulatory scrutiny impacts patent status and market exclusivity. Some formulations, especially branded versions such as Zinecard, face patent expirations, paving the way for generic competition. Conversely, novel formulations or combinations under clinical investigation may extend market exclusivity. Regulatory pathways for biosimilars or enhanced delivery systems could further diversify the product landscape.

Market Size and Segmentation

The global market for dexrazoxane hydrochloride is driven predominantly by oncology drug regimens requiring cardioprotection. The market was valued at approximately USD 150 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-6% over the next five years, reaching USD 190-200 million by 2027 [3].

Segmentation factors include:

• Geographical Distribution: North America accounts for the largest share, propelled by high cancer incidence rates and advanced healthcare infrastructure. Asia-Pacific is emerging as a significant growth region due to increasing cancer prevalence and expanding healthcare access.

• Patient Demographics: The majority of demand stems from adult oncology patients receiving anthracyclines; pediatric use constitutes a smaller segment but remains critical in high-risk pediatric cancers.

• Indication-Specific Demand: High-dose chemotherapy protocols and treatments requiring multiple anthracycline cycles drive higher utilization rates.

Competitive Landscape

The competitive environment features established pharmaceutical companies with proprietary formulations and newer entrants developing innovative delivery methods. Key players include:

• Pharmaceutical Giants: Pfizer, previously the primary provider via Zinecard, has faced patent expirations and market fragmentation [4].

• Generic Manufacturers: Several regional companies now produce generic dexrazoxane hydrochloride, reducing pricing and increasing accessibility.

• Emerging Alternatives: Research into novel cardioprotective agents and biologics may influence future competition, although dexrazoxane remains the gold standard presently.

Patent and Intellectual Property Considerations

The original patent for dexrazoxane expired in the late 2000s, leading to a surge in generic options. Nonetheless, patents on specific formulations, delivery systems, or combination therapies continue to provide market exclusivity avenues for certain products. Patents related to methods of administration, such as infusion devices, could influence product differentiation.

The expiration of fundamental patents has exerted downward pressure on prices, creating a more price-sensitive market environment, especially in emerging countries. Companies investing in new formulations or delivery mechanisms seek to extend market exclusivity and improve therapeutic efficiency.

Emerging Trends and Innovation

While current utilization is well-established, ongoing trends include:

• Combination Therapies: Developing formulations combining dexrazoxane with chemotherapeutic agents to streamline treatment protocols.

• Personalized Medicine: Identifying genetic markers predicting cardiotoxicity risk to optimize dexrazoxane usage.

• Novel Delivery Systems: Liposomal or nanoparticle-based formulations to improve bioavailability and reduce side effects.

• Regulatory Approvals for Expanded Indications: Potential approvals for use in other contexts, such as radiotherapy-induced cardiotoxicity or cardiomyopathies linked to other agents.

Market Challenges and Barriers

Key challenges comprise:

• Safety Concerns: Regulatory warnings about secondary malignancies may constrain prescription growth.

• Competitive Alternatives: The advent of less cardiotoxic anthracycline analogs and cardioprotective agents like carvedilol or acebutolol.

• Pricing and Reimbursement: Cost-containment pressures and variable reimbursement policies influence prescribing habits.

• Regulatory Limitations: Stringent approval processes and safety monitoring requirements could slow market expansion.

Financial Trajectory and Investment Insights

Despite challenges, demand stability rooted in the ongoing necessity of cardioprotection suggests a steady financial trajectory. Revenue growth hinges on:

• Market penetration in emerging regions: Expansion into markets with rising cancer incidence and underpenetrated healthcare systems.

• Innovative product development: Introduction of new formulations, especially those offering improved safety or convenience.

• Clinical adoption: Updating treatment protocols based on emerging evidence to include dexrazoxane alongside newer chemotherapeutic regimens.

Pharmaceutical and biotech firms focusing on expanding indications, enhancing formulations, or integrating dexrazoxane into combination therapies stand to benefit from this trajectory. Strategic investments in clinical research and regulatory navigation are critical to capitalize on these opportunities.

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Key Takeaways

• Stable Demand with Growth Potential: Dexrazoxane hydrochloride remains essential for cardioprotection in chemotherapy, with projected moderate growth driven by expanding oncology markets and increased awareness.

• Patent Expirations and Market Fragmentation: Patent expirations have increased generic competition, exerting pricing pressures but also widening access.

• Regulatory and Safety Nuances: Safety warnings impact prescribing patterns; ongoing research and regulatory approvals can influence future usage.

• Innovation as a Market Differentiator: Novel formulations and expanded indications may create new revenue streams and extend product life cycles.

• Regional Opportunities: Emerging markets offer substantial growth potential due to rising cancer burdens and healthcare infrastructure expansion.

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FAQs

1. What factors influence the prescribing of dexrazoxane hydrochloride?
Prescribing is influenced by clinical guidelines, perceived safety profiles, patient risk stratification for cardiotoxicity, and regulatory recommendations. Safety concerns regarding secondary malignancies have made some clinicians cautious.

2. How does patent expiration affect the market for dexrazoxane?
Patent expirations have led to increased generic manufacturing, reducing prices and expanding accessibility but decreasing revenue potential for original innovator products.

3. Are there any recent regulatory approvals that could impact dexrazoxane's market?
While ongoing safety evaluations are common, most approvals remain stable. However, approval for new indications or formulations could boost market prospects.

4. What are the main challenges for companies seeking to extend dexrazoxane’s market?
Challenges include regulatory hurdles, safety concerns, competition from new cardioprotective agents, and the need for clinical evidence to support expanded indications.

5. What trends could shape the future demand for dexrazoxane?
Advances in personalized medicine, improved cardioprotective strategies, and the development of combination therapies will influence demand; however, competition from alternative agents will also play a role.

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Sources:

1. Lipshultz SE, et al. "Cardioprotection during anthracycline therapy." Oncology. 2011.
2. U.S. Food and Drug Administration. "Zinecard (dexrazoxane) Information." 1995.
3. MarketsandMarkets. "Oncology Drugs Market." 2022.
4. Pfizer Annual Reports. 2010-2022.