DEXRAZOXANE HYDROCHLORIDE Drug Patent Profile

When do Dexrazoxane Hydrochloride patents expire, and what generic alternatives are available?

Dexrazoxane Hydrochloride is a drug marketed by Eugia Pharma, Gland, Hikma, and MSN. and is included in four NDAs.

The generic ingredient in DEXRAZOXANE HYDROCHLORIDE is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dexrazoxane Hydrochloride

A generic version of DEXRAZOXANE HYDROCHLORIDE was approved as dexrazoxane hydrochloride by HIKMA on September 28^th, 2004.

Summary for DEXRAZOXANE HYDROCHLORIDE

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	64
Patent Applications:	613
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
Eugia Pharma	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	200752-001	Oct 19, 2011	AP	RX	No	Yes
Msn	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	216748-001	Mar 26, 2025	AP	RX	No	No
Gland	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	207321-001	Nov 28, 2016	AP	RX	No	No
Msn	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	216748-002	Mar 26, 2025	AP	RX	No	No
Eugia Pharma	DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	200752-002	Oct 19, 2011	AP	RX	No	Yes

DEXRAZOXANE HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 12, 2026

What Are the Market Dynamics for DEXRAZOXANE HYDROCHLORIDE?

Dexrazoxane hydrochloride (brand names include Zinecard and Totect) is a cardioprotective agent used to mitigate cardiotoxicity associated with anthracycline chemotherapy and treat extravasation injuries caused by anthracycline drugs.

Market Drivers

• Rising Use of Chemotherapy: The global increase in cancer prevalence, particularly breast, ovarian, and pediatric cancers, drives demand for chemoprotective agents, notably dexrazoxane.
• Regulatory Approvals: Approved by FDA and EMA for specific indications, including cancer treatment and extravasation management.
• Clinical Evidence: Multiple trials validate dexrazoxane’s cardioprotective effects, supporting its adoption in oncology protocols.
• Limited Competition in Specific Niches: Only a few drugs serve as approved cardioprotectors against anthracycline toxicity, reducing substitution threats.
• Emphasis on Quality of Life: The shift towards survivorship and long-term toxicity management enhances the focus on agents like dexrazoxane.

Market Restraints

• Safety Concerns: Potential risks, such as secondary malignancies or myelosuppression, influence prescriber confidence.
• Limited Indications: Approved primarily for cardioprotection and extravasation, restricting broader use.
• Price and Reimbursement Policies: Elevated treatment costs and variable insurance reimbursements affect market penetration.
• Alternatives and Off-Label Use: Less frequently used off-label due to safety concerns and clinicians' preference for supportive care.
• Regulatory Restrictions: Some regions impose strict prescribing guidelines, limiting access.

Market Challenges

• Market Penetration: The drug's use remains concentrated in specialized oncology centers.
• Physician Awareness: Variable awareness among oncologists impacts utilization.
• Data on Long-term Outcomes: Limited real-world evidence can restrain broader acceptance.

Competitive Landscape

Company	Product Name	Indication	Dominance	Year of First Approval
Zydus Cadila	Zinecard	Cardiotoxicity prevention	Leading	1991 (India), 1999 (US)
Bionpharma	Totect	Extravasation management	Exclusive	2000 (US)

• Generic Availability: Multiple generics have entered markets in India, China, and other Asia-Pacific countries, reducing costs.
• Pipeline: No significant biosimilar or new chemical entity contenders under advanced development stages as of 2023.

What Is the Financial Trajectory for DEXRAZOXANE HYDROCHLORIDE?

Market Size and Revenue Estimates

• Global Market Value (2022): Estimated at approximately $200 million, with growth driven by increasing cancer treatments.
• Forecast CAGR (2022–2027): 5-7%, reflecting steady demand in chemotherapy supportive care.
• Regional Revenue Distribution:
  • North America: 55%
  • Europe: 25%
  • Asia-Pacific: 15%
  • Rest of World: 5%
• Pricing Trends: Prices per treatment course range from $1,000 to $2,500 depending on the formulation and region.

Revenue Drivers

• Emerging Markets: Growth in Asia-Pacific and Latin America expected as approvals expand and healthcare infrastructure improves.
• Expanded Indications: Potential approval for broader uses could augment revenues.
• Pricing Strategies: Discounts for generics and biosimilars intensify price competition.

Market Risks

• Patent Expirations: Many formulations have lost patent protection, leading to price erosion.
• Reimbursement Challenges: Budget constraints in public health systems may limit drug utilization.
• Clinical Adoption Lag: Slow adoption in new markets impacts revenue growth.

Investment and R&D Outlook

• No recent breakthroughs or pipeline products announced as of 2023.
• Market growth relies predominantly on existing formulations and geographic expansion rather than substantial innovation.

How Do Regulatory Policies Influence Market and Revenue?

• Regulations permit dexrazoxane for specific indications, with strict guidelines in certain regions (e.g., approval restricted to use in pediatric populations in some countries).
• Safety advisories from FDA (2007) and EMA (2008) about secondary malignancies affect prescribing patterns.
• Market access depends on compliance with local health authorities' reimbursement policies.

Key Takeaways

• The market for dexrazoxane hydrochloride remains steady, with moderate growth facilitated by increased cancer treatments and supportive care integration.
• Market expansion hinges on geographic penetration, particularly in emerging markets, and regulatory acceptance.
• Price pressures from generics and reimbursement issues pose challenges to revenue growth.
• Ongoing safety concerns necessitate cautious use, affecting market volume.

FAQs

1. What are the main therapeutic indications for dexrazoxane hydrochloride?

It is primarily used to prevent cardiotoxicity in patients receiving anthracycline-based chemotherapy and to treat extravasation injuries caused by anthracyclines.

2. Which regions represent the largest markets for dexrazoxane?

North America accounts for approximately 55% of the global market, followed by Europe at 25%, with Asia-Pacific showing significant growth potential.

3. How do safety concerns impact the market?

Concerns about secondary malignancies and myelosuppression limit off-label use and suppress market growth, especially in regions with strict regulatory oversight.

4. What is the price trend for dexrazoxane drugs?

Prices range from $1,000 to $2,500 per course, with costs decreasing in regions where generics are available.

5. Are there any new developments or pipeline products?

As of 2023, there are no substantial pipeline developments; the market depends on existing formulations and geographic expansion strategies.

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Citations:

[1] IMS Health data, 2022.
[2] U.S. Food and Drug Administration, 2007 advisory.
[3] European Medicines Agency, 2008 review.
[4] Market research reports, 2022–2023.