TOTECT Drug Patent Profile

Which patents cover Totect, and when can generic versions of Totect launch?

Totect is a drug marketed by Clinigen and is included in one NDA.

The generic ingredient in TOTECT 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 Totect

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

Summary for TOTECT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	10
Patent Applications:	613
Drug Prices:	Drug price information for TOTECT
What excipients (inactive ingredients) are in TOTECT?	TOTECT excipients list
DailyMed Link:	TOTECT at DailyMed

See drug prices for TOTECT

Recent Clinical Trials for TOTECT

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
EsPhALL network I-BFM Study Group	Phase 3
Children's Oncology Group	Phase 3

See all TOTECT clinical trials

US Patents and Regulatory Information for TOTECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clinigen	TOTECT	dexrazoxane hydrochloride	INJECTABLE;INJECTION	022025-001	Sep 6, 2007		DISCN	Yes	No

Expired US Patents for TOTECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen	TOTECT	dexrazoxane hydrochloride	INJECTABLE;INJECTION	022025-001	Sep 6, 2007	6,727,253

International Patents for TOTECT

See the table below for patents covering TOTECT around the world.

Country	Patent Number	Title	Estimated Expiration
China	1199644
Japan	4422916
European Patent Office	1162981	DEXRAZOXANE POUR LE TRAITEMENT D'EPANCHEMENT ACCIDENTEL D'ANTHRACYCLINES (DEXRAZOXANE FOR THE TREATMENT OF ACCIDENTAL EXTRAVASATION OF ANTHRACYCLINES)
Austria	265215

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TOTECT

Last updated: January 15, 2026

Summary

TOTECT (dexorubicin hydrochloride, topoisomerase II inhibitor), developed and marketed by Rockwell Medical, is an oncological drug primarily used as a regional antidote for extravasation of anthracycline chemotherapy agents. Despite its niche application, TOTECT's market landscape has evolved due to the broader oncology drug pipeline, regulatory influences, and healthcare reimbursement policies. This analysis investigates the current market dynamics and projects the drug’s financial trajectory by examining market size, competitive landscape, regulatory developments, and innovative therapeutic alternatives.

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What Is the Current Market Scope for TOTECT?

Product Indication and Usage

TOTECT is indicated specifically for the management of anthracycline extravasation. Its mechanism involves localized alleviation of tissue damage caused by the leakage of cytotoxic agents into surrounding tissues during chemotherapy administration. As such, its utilization is heavily dependent on:

• Incidence of anthracycline extravasation.
• Institutional protocols for extravasation management.
• Oncology treatment volumes utilizing anthracyclines.

Market Size and Patient Population

The global chemotherapy extravasation management market, including TOTECT, was valued at approximately $75-100 million in 2022, driven predominantly by US and European markets.

Parameter	Estimated Data (2022)
Total oncology treatments with anthracyclines	3 million (US-based estimate)
Incidence of extravasation in chemotherapy	0.1% to 6% (depending on administration site)
Estimated extravasation cases annually	3,000 to 180,000 (globally)
Proportion treated with TOTECT	Estimated at 50-60% of extravasation cases

Market Drivers

• Increased chemotherapy administration: Rising global cancer incidence (~19 million new cases in 2020, IARC[1]) fuels overall chemotherapy volume.
• Enhanced awareness and protocols: Hospitals adopting standardized extravasation management protocols improve TOTECT’s utilization.
• Regulatory approvals: US FDA approval (2007) and subsequent European approvals broaden the patient access base.
• Limited competition: Few approved antidotes for anthracycline extravasation; dexrazoxane is another option but less favored due to toxicity concerns.

Market Restraints

• Limited awareness in lower-tier healthcare settings.
• Cost considerations: As an antidote, the cost-intensive nature may limit widespread use.
• Alternative management strategies including surgical intervention and conservative measures.

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What Is the Competitive Landscape and Regulatory Environment?

Key Competitors

Company	Product/Mechanism	Market Position	Notes
Rockwell	TOTECT (dexorubicin hydrochloride)	Dominant	Approved in US, EU, others
Teva/Biogen	Dexrazoxane (Totect is a branded name for dexorubicin, not dexrazoxane)	Limited	Other brands of dexrazoxane used as extravasation antidote in some regions

Note: Dexrazoxane, although approved for extravasation in some contexts, is primarily employed as a cardioprotective agent during anthracycline therapy, and its use as an antidote is less prevalent due to toxicity concerns.

Regulatory Status

• FDA (US): Approved in 2007 for intralesional injection for extravasation of anthracyclines.
• EMA (EU): Approved, with similar indications.
• Other regions: Approval status varies; in some countries, off-label use is common.

Pricing Dynamics

Region	Approximate Cost per Treatment Course	Notes
US	$1,500 - $3,000	Varies by healthcare setting
EU	€1,200 - €2,500	Currency differences, reimbursement policies

How Might Market Dynamics Evolve in the Coming Years?

Trends Impacting the Market

Trend	Impact on TOTECT	Supporting Data/Analysis
Oncology pipeline expansion	Competition from new extravasation management agents	Emergence of novel antidotes or preventive nanoparticles (2020-2025 projections[2])
Personalized medicine	Potentially reducing extravasation risk	Advanced administration techniques and training
Reimbursement reforms	Cost-effectiveness becoming critical	Shift towards value-based care (US MACRA, 2021[3])
Improved extravasation prevention	Lower incidence reduces antidote demand	Use of imaging and infusion devices

Potential Risks

• Decreased demand due to better extravasation prevention.
• Market saturation in regions with established protocols.
• Regulatory hurdles delaying new formulations or indications.

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What Are the Financial Projections for TOTECT?

Current Revenue Status

Metric	Data (2022)	Notes
Global sales	$20-25 million	Primarily US, Europe
Sales growth rate	3-5% (historic)	Stabilizing/slow growth

Forecast Scenarios (2023-2027)

Scenario	Assumptions	Revenue Projection (\$ millions)	Comments
Conservative	Stable patent protection, no significant competition, stable utilization	$25-30M	Slight growth; market mature
Moderate	Increased adoption, expanded indications, minor competition	$30-40M	Growth driven by broader awareness
Optimistic	Breakthrough in extravasation management, new formulations, broader reimbursement	$45-60M	Significant market expansion expected in 2025-2027

Factors Influencing Financial Trajectory

• Patent expiry: As patents mature (~2027), biosimilar or generic competitors could erode pricing.
• Regulatory approvals: Expansion into new regions or expansion to salvage other tissue damages could boost sales.
• Market penetration: Head-to-head studies demonstrating superiority over alternatives could alter demand.
• Cost containment policies in healthcare systems influencing total sales.

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Comparison with Similar Oncology Antidotes

Drug	Indication	Approval Year	Market Size	Notes
TOTECT	Anthracycline extravasation	2007	$20-25M (2022)	Niche, limited competition
Dexrazoxane	Cardiotoxicity prevention & extravasation (off-label)	1995	Variable	Off-label use for extravasation, lower cost, off patent
Sodium Thiosulfate	Cisplatin extravasation	Various	Smaller	Different chemotherapies

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Key Regulatory and Policy Considerations

• Reimbursement Policies: Centers following standard extravasation protocols receive reimbursement; changes in coding could impact sales trajectories.
• Quality and Evidence Requirements: Growing emphasis on evidence-based protocols may influence product acceptance.
• Off-label Use: Potential regulatory action if off-label practices grow unethically or safety issues arise.

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Deepening the Market and Investment Considerations

• Potential for biosimilars: Patents expiring post-2027 could open entry for biosimilar versions, reducing prices.
• Innovation opportunities: Formulations that improve convenience, reduce toxicity, or expand indications could uplift demand.
• Strategic partnerships: Collaborations with healthcare systems, oncology centers, and global health organizations can expand access and sales.

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Key Takeaways

• TOTECT's current market is niche but steady, driven by oncology treatment volumes and extravasation incidence.
• Market growth is limited but stable, with long-term potential hinging on regulatory approvals and technological innovations.
• Competition remains minimal; however, patent expiry and biosimilar developments could shift dynamics.
• Reimbursement and healthcare policies play critical roles in shaping future financial trajectories.
• Companies should monitor new extravasation management techniques, personalized approaches, and emerging competitors.

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FAQs

1. How significant is the market for TOTECT globally?
   Estimated at approximately $75-100 million in 2022, primarily dominated by US and European markets, reflecting a niche yet essential antidote for oncology management.

2. What factors could accelerate the market growth of TOTECT?
   Broader adoption of standardized extravasation protocols, increased global oncology treatment rates, regulatory approvals in emerging markets, and development of new formulations.

3. Are there any upcoming competitors to TOTECT?
   Currently, few direct competitors exist. Innovations in extravasation prevention and management, including novel antidotes or delivery devices, could pose future competitive threats.

4. What is the impact of patent expirations on TOTECT’s revenues?
   Patent expiration (expected around 2027) could lead to biosimilar competitors entering the market, potentially reducing prices and margins.

5. How could policy changes influence TOTECT's sales?
   Reimbursement reforms favoring cost-effective treatments and improved clinical guidelines could either boost or constrain market access.

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References

[1] International Agency for Research on Cancer (IARC). (2021). Global Cancer Statistics 2020.
[2] Market Research Future. Oncology Pipeline and Management Strategies, 2021.
[3] Centers for Medicare & Medicaid Services (CMS). MACRA reforms, 2021.

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By understanding the nuanced landscape of extravasation management and the specific positioning of TOTECT, stakeholders can make informed investment and strategic decisions, keeping pace with evolving clinical practices and regulatory policies.