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 is one drug master file entry for this compound. Six 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:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	64
Patent Applications:	669
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

Dexrazoxane Hydrochloride Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 1, 2026

Dexrazoxane hydrochloride is an established generic injectable used in two distinct settings: cardioprotection during doxorubicin therapy and emergency treatment of anthracycline extravasation. Its commercial profile is mature, with limited patent protection, no meaningful biosimilar risk, and demand driven by hospital oncology protocols rather than broad retail prescribing. Revenue opportunities remain concentrated in branded supply, hospital contracting, shortage resilience, and the higher-value extravasation indication.

What is the current market position of dexrazoxane hydrochloride?

Dexrazoxane hydrochloride is a small-molecule topoisomerase II-related cardioprotective agent supplied as a sterile intravenous product. It is marketed in the United States primarily through:

Product	Sponsor or commercial channel	FDA use	Typical presentation
Zinecard	Pfizer and authorized generic channels	Reduction of doxorubicin-related cardiomyopathy in selected breast-cancer patients	250 mg and 500 mg vials
Totect	Cumberland Pharmaceuticals	Treatment of anthracycline extravasation	Multidose emergency treatment regimen
Generic dexrazoxane hydrochloride	Multiple injectable-drug manufacturers and distributors	Primarily the Zinecard-label cardioprotection indication	250 mg and 500 mg vials

The two indications have different commercial economics. Cardiac protection is protocol-driven and competes with oncologists' patient-selection criteria, cumulative anthracycline exposure limits, and alternative oncology regimens. Extravasation treatment is an emergency-use product. Hospitals must maintain immediate access even though utilization is infrequent, creating a stocking and availability premium.

FDA labeling states that Zinecard is indicated for women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m² and will continue doxorubicin therapy. It is not recommended for use with the initial doxorubicin dose. Totect is administered over three days after anthracycline extravasation, with dose timing and dose-reduction provisions specified in its label (U.S. Food and Drug Administration [FDA], 2014a, 2014b).

How large is the dexrazoxane hydrochloride market?

No authoritative public source reports global dexrazoxane hydrochloride sales by product, indication, or manufacturer. Public company filings also do not consistently separate dexrazoxane revenue from broader specialty-pharmaceutical portfolios. Market-research estimates vary widely because they often combine cardioprotection and extravasation products, count hospital acquisition revenue differently, and include or exclude generic supply.

The commercial market is best characterized as a small, specialized hospital-injectable segment with the following properties:

• Low prescription volume relative to mainstream oncology drugs.
• High clinical value per stocked dose in extravasation treatment.
• Concentrated purchasing through hospitals, group purchasing organizations, oncology practices, and specialty distributors.
• Limited consumer or retail pharmacy exposure.
• Revenue sensitivity to chemotherapy utilization, anthracycline use, generic price competition, and manufacturing continuity.
• Greater price resistance for emergency extravasation supply than for routine cardioprotection.

The product does not have the scale of a conventional oncology franchise. Its value lies in niche clinical necessity, hospital formulary inclusion, and supply reliability.

What is driving demand for dexrazoxane hydrochloride?

Anthracycline use remains the core demand variable

Doxorubicin and related anthracyclines continue to be used in breast cancer, lymphomas, sarcomas, and other malignancies. Dexrazoxane demand therefore tracks:

1. The number of patients receiving anthracyclines.
2. The proportion receiving cumulative doses associated with cardiotoxicity risk.
3. Institutional adoption of cardioprotection protocols.
4. The frequency of extravasation events.
5. Hospital inventory and emergency preparedness policies.

The cardioprotection market is constrained by selective labeling and clinical debate over when dexrazoxane should be used. The extravasation market is smaller in units but has stronger operational value because treatment must begin rapidly after an event.

Hospital supply reliability supports pricing

Dexrazoxane hydrochloride is a sterile injectable. Manufacturing requires validated aseptic processing, sterile fill-finish capacity, container-closure controls, and reliable active pharmaceutical ingredient supply. These requirements create barriers that do not exist for ordinary oral generics.

A manufacturer can face commercial disruption without losing patent protection if it experiences:

• Sterile manufacturing deviations.
• Component shortages.
• Limited lyophilization capacity.
• Delayed regulatory release testing.
• Distribution interruptions.
• Low production economics at small batch sizes.

For Totect, hospitals may value product availability more than nominal unit price because the product is intended for immediate use. This gives a branded supplier an opportunity to defend share through inventory programs, service levels, and emergency access rather than patent exclusivity.

What FDA regulatory status applies to dexrazoxane hydrochloride?

Zinecard was approved in 1995 for reduction of doxorubicin-associated cardiomyopathy. Totect was approved in 2007 for anthracycline extravasation, an indication that was granted orphan-drug status and carried the statutory orphan exclusivity period applicable at approval (FDA, 2014a, 2014b).

FDA regulatory timeline

Year	Regulatory event
1995	FDA approval of Zinecard for selected doxorubicin-treated metastatic breast-cancer patients
2007	FDA approval of Totect for anthracycline extravasation
2014	Current FDA labeling reflects established dosing, warnings, and administration requirements
Present	Marketed as branded and generic sterile injectable dexrazoxane hydrochloride products

The original regulatory exclusivity periods have expired. The product is now governed primarily by generic-drug approval standards, manufacturing compliance, labeling requirements, and hospital procurement economics.

What patents protect dexrazoxane hydrochloride?

Dexrazoxane hydrochloride has no meaningful active composition-of-matter patent estate in the United States. The active ingredient is an old small molecule, and the foundational patent term has expired.

Orange Book status

The relevant U.S. intellectual-property position is summarized below:

Protection category	Current commercial significance
Composition-of-matter patents	Expired
Original product patents	Expired or commercially exhausted
Regulatory exclusivity	Expired
Active Orange Book patent barrier	No material barrier identified for the established injectable product
Formulation patents	No widely recognized, commercially decisive active estate for conventional dexrazoxane hydrochloride injection
Method-of-use patents	Any historical protection does not prevent ordinary generic competition for the approved uses

FDA Orange Book records are the controlling source for listed patents and exclusivity associated with approved drugs. The established dexrazoxane products do not present the type of active Orange Book patent wall associated with newer oncology products (FDA, 2024a).

When does dexrazoxane hydrochloride lose exclusivity?

Dexrazoxane hydrochloride has already lost its principal exclusivity layers.

• Small-molecule patent exclusivity: expired.
• Zinecard market protection: expired.
• Totect orphan exclusivity: expired.
• Generic competition: legally available subject to FDA approval and commercial supply.
• Biosimilar exclusivity: not applicable because dexrazoxane is a small molecule, not a biologic.

The commercial question is therefore not when exclusivity will expire. It is how many approved suppliers can sustain reliable sterile injectable production and how aggressively hospitals or group purchasing organizations negotiate price.

Are there Paragraph IV challenges to dexrazoxane hydrochloride?

Paragraph IV litigation is not a major current market feature for dexrazoxane hydrochloride. The product's principal patent terms and regulatory exclusivities have expired, reducing the need for a formal Paragraph IV strategy.

A generic applicant could still use an abbreviated new drug application pathway when the reference product and labeling permit. However, the commercial incentive to litigate is limited because:

• The reference product has a small market.
• No durable patent barrier appears to support a high-value litigation settlement.
• Generic entry can occur through ordinary approval after applicable regulatory requirements are met.
• Sterile injectable manufacturing may be a greater barrier than patent clearance.

The absence of major Paragraph IV activity does not mean competition is absent. It means competition is likely to occur through abbreviated approval, contract manufacturing, hospital tenders, and distributor access.

What formulations are protected by dexrazoxane patents?

The principal U.S. products are conventional lyophilized or injectable dexrazoxane hydrochloride presentations requiring reconstitution and intravenous administration. No active formulation patent is widely recognized as controlling the established commercial market.

Technical barriers remain despite weak patent protection

A generic manufacturer must still demonstrate:

• Pharmaceutical equivalence to the reference product.
• Appropriate strength and container configuration.
• Sterility and endotoxin control.
• Stability through shelf life.
• Validated reconstitution performance.
• Correct labeling and administration instructions.
• Compliance with current good manufacturing practice requirements.

These controls create regulatory and operational barriers but do not produce the margin protection associated with an enforceable formulation patent.

Potential future differentiation could involve ready-to-use presentations, reduced reconstitution steps, improved storage conditions, or emergency-department packaging. Those features could support a new 505(b)(2) product if they provide a clinically meaningful difference, but they would require new development, FDA review, and evidence supporting the change.

How does Totect compare with Zinecard?

Factor	Totect	Zinecard and generic dexrazoxane
Primary use	Anthracycline extravasation	Doxorubicin cardioprotection
Treatment setting	Emergency hospital response	Planned oncology treatment
Dosing pattern	Three consecutive days after extravasation	Administered before specified doxorubicin doses
Demand frequency	Low event frequency	Linked to cumulative anthracycline treatment
Stocking requirement	Immediate hospital availability	Protocol and patient selection dependent
Commercial differentiation	Emergency access, service, supply reliability	Price, formulary status, and clinical protocol
Generic substitution pressure	Potentially lower because of emergency inventory needs	Higher because of routine procurement
Patent protection	Expired	Expired

Totect has stronger niche positioning because failure to stock an extravasation antidote creates institutional risk. Zinecard has a larger theoretical patient pool but faces more direct substitution and protocol scrutiny.

What companies are competing in the dexrazoxane hydrochloride market?

Competition includes the branded product sponsors, generic injectable manufacturers, contract manufacturers, specialty distributors, and hospital purchasing organizations. The market is fragmented relative to major oncology categories, but the number of suppliers may be limited by sterile manufacturing economics.

Cumberland Pharmaceuticals is the most visible commercial participant associated with Totect in the United States. Pfizer is associated with the Zinecard brand. Generic dexrazoxane supply depends on FDA-approved manufacturers and their commercial distributors, which can change over time as companies enter, exit, or suspend production.

The strongest competitive advantages are:

• Reliable sterile supply.
• Hospital formulary access.
• Emergency inventory support.
• Competitive acquisition cost.
• Pharmacist and oncology-account coverage.
• Regulatory compliance history.
• Product availability during injectable-drug shortages.

What is the financial trajectory for dexrazoxane hydrochloride?

Dexrazoxane is a mature, low-growth pharmaceutical asset. Its financial trajectory is more likely to reflect stable or fluctuating niche revenue than rapid expansion.

Revenue outlook by driver

Driver	Directional effect
Continued anthracycline use	Supports baseline demand
Generic entry and price competition	Pressures routine cardioprotection revenue
Hospital shortage or supply interruption	Can temporarily increase revenue for available suppliers
Emergency extravasation stocking	Supports premium positioning for Totect
Greater cardiotoxicity monitoring	May reduce or selectively increase dexrazoxane use depending on protocol
New ready-to-use formulation	Could expand value per dose if clinically and operationally differentiated
Reduced anthracycline use	Long-term volume pressure
Hospital purchasing consolidation	Margin pressure through tenders and group purchasing contracts

Cumberland's public financial filings report company-level results and product portfolio information, but do not provide a consistent, standalone long-term revenue series for Totect sufficient to calculate a precise compound annual growth rate. The absence of product-level disclosure limits reliable valuation of Totect as an individual asset (Cumberland Pharmaceuticals, 2024).

The likely financial profile is:

• Stable demand from institutional stocking.
• High variability from low absolute unit volume.
• Gross-margin sensitivity to manufacturing scale.
• Price resilience for emergency-use supply.
• Greater price pressure for cardioprotection products with generic alternatives.
• Limited upside without a new formulation, geographic expansion, or broader guideline adoption.

What patent litigation and settlement risks affect dexrazoxane?

No major active U.S. patent dispute is central to the established dexrazoxane hydrochloride market in the cited FDA and company records. There is no apparent patent settlement structure comparable to those governing recently launched oncology drugs.

Commercial disputes are more likely to involve:

• Supply agreements.
• Distributor termination or access.
• Hospital contracting.
• Product quality.
• Shortage allocation.
• Regulatory compliance.
• Brand-versus-generic substitution.

The litigation risk is therefore operational rather than patent-driven.

What generic launch scenarios exist for dexrazoxane hydrochloride?

Scenario 1: Routine generic price erosion

Additional generic suppliers enter the market. Hospitals use competitive purchasing to reduce acquisition cost, particularly for planned cardioprotection. Branded revenue declines while total unit availability increases.

Scenario 2: Limited supplier market

Only a small number of manufacturers maintain commercial supply because sterile injectable production is difficult to scale profitably. Prices remain higher than expected from patent expiration, and hospital purchasers prioritize continuity.

Scenario 3: Branded emergency-use defense

Totect retains a premium position in extravasation through hospital stocking programs, rapid replacement, account support, and supply guarantees. Generic products capture more routine cardioprotection volume but do not fully displace the emergency-use brand.

Scenario 4: Product reformulation

A manufacturer develops a ready-to-use or simplified-administration dexrazoxane product. New formulation or delivery patents could support temporary differentiation, although the regulatory and clinical burden would be materially higher than for a standard generic injection.

What geographic coverage does dexrazoxane hydrochloride have?

Dexrazoxane products are marketed in multiple jurisdictions, but the commercial structure varies by country. The United States has separate branded positions for cardioprotection and extravasation. European and other markets may use different brand names, national reimbursement rules, hospital tenders, and approved indications.

Geographic expansion is constrained by:

• Local injectable-drug registration.
• National reimbursement.
• Hospital tender pricing.
• Anthracycline treatment patterns.
• Orphan-drug and pediatric requirements.
• Local manufacturing or import controls.
• Pharmacovigilance obligations.

The United States remains the most commercially visible market because of branded Totect promotion and the size of the U.S. oncology hospital system. European and emerging markets may offer volume, but typically with lower net pricing and more centralized procurement.

How strong is the dexrazoxane hydrochloride patent estate?

The patent estate is weak for exclusivity purposes but the product retains practical barriers.

Estate component	Assessment
Composition patent	Expired
Active Orange Book protection	Not commercially significant
Regulatory exclusivity	Expired
Method-of-use protection	Limited current blocking effect
Formulation protection	No established broad barrier for standard injection
Manufacturing know-how	Moderate practical importance
Sterile fill-finish capability	High practical importance
Hospital relationships	Moderate commercial importance
Emergency inventory infrastructure	High importance for Totect

The investment thesis is therefore based on manufacturing execution and channel control, not patent duration.

Key Takeaways

• Dexrazoxane hydrochloride is a mature hospital injectable with two distinct commercial uses.
• Totect benefits from emergency-use stocking and may retain more pricing power than routine cardioprotection products.
• Zinecard and generic dexrazoxane face greater substitution and hospital procurement pressure.
• Foundational patents and regulatory exclusivities have expired.
• No meaningful active Orange Book patent barrier controls the established market.
• Biosimilar risk is irrelevant because dexrazoxane is a small molecule.
• Paragraph IV litigation and patent settlements are not major current market drivers.
• Sterile manufacturing, product availability, hospital contracting, and distributor access are more important than intellectual property.
• Public filings do not disclose a sufficiently consistent standalone revenue history to support a precise Totect growth rate.
• Future upside would require a differentiated formulation, expanded use, improved emergency logistics, or stronger adoption of cardioprotection protocols.

FAQs

Is dexrazoxane hydrochloride a biologic or a generic small molecule?

It is a small-molecule drug. Generic applicants use an abbreviated new drug application pathway when the reference-product requirements are satisfied. Biosimilar approval rules do not apply.

Why can Totect maintain value after patent expiration?

Totect is used for an infrequent but time-sensitive hospital emergency. Hospitals may pay for dependable availability, rapid replacement, and inventory support even when equivalent generic products exist.

Does dexrazoxane hydrochloride have orphan-drug protection?

Totect received orphan-drug approval for anthracycline extravasation, but the applicable orphan exclusivity period has expired. Historical orphan designation does not create current market exclusivity.

Can a new dexrazoxane formulation receive new patents?

Yes. A ready-to-use presentation, new delivery system, storage improvement, or administration feature could potentially support patent protection if it meets applicable patentability standards. The new product would also require FDA approval.

What is the main investment risk for dexrazoxane hydrochloride?

The primary risks are small market size, generic price pressure, dependence on sterile manufacturing, low utilization frequency, hospital purchasing concentration, and reduced anthracycline use in favor of alternative cancer regimens.

References

1. Cumberland Pharmaceuticals, Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.

2. U.S. Food and Drug Administration. (2014a). Zinecard (dexrazoxane hydrochloride for injection) prescribing information.

3. U.S. Food and Drug Administration. (2014b). Totect (dexrazoxane for injection) prescribing information.

4. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book.

5. U.S. Food and Drug Administration. (2024b). Drugs@FDA: FDA-approved drugs database.