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
Children's Oncology Group	Phase 3
EsPhALL network I-BFM Study 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

International Patents for TOTECT

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

Country	Patent Number	Title	Estimated Expiration
Australia	3272600
Germany	1162981
World Intellectual Property Organization (WIPO)	0054782
Australia	769533
European Patent Office	1162981	DEXRAZOXANE POUR LE TRAITEMENT D'EPANCHEMENT ACCIDENTEL D'ANTHRACYCLINES (DEXRAZOXANE FOR THE TREATMENT OF ACCIDENTAL EXTRAVASATION OF ANTHRACYCLINES)
Norway	20014433
Denmark	1162981

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TOTECT

Last updated: July 29, 2025

Introduction

TOTECT (dexrazoxane hydrochloride) holds a unique position in the oncology supportive care landscape, primarily indicated for reducing the incidence and severity of cardiomyopathy associated with anthracycline chemotherapy. As an adjunct therapy, its market dynamics are influenced by a complex interplay of clinical efficacy, regulatory landscape, competitive environment, and evolving oncology treatment paradigms. This analysis explores the current market forces shaping TOTECT’s trajectory and forecasts its financial prospects.

Product Overview and Clinical Context

TOTECT, developed by Pfizer, was approved by the U.S. Food and Drug Administration (FDA) in 1995. It serves as a cardioprotective agent, mitigating anthracycline-induced cardiotoxicity—a significant limitation in the use of potent chemotherapeutic agents like doxorubicin and daunorubicin. Its mechanism involves chelating iron and preventing free radical formation, thereby protecting cardiac tissue during cancer treatment.

Despite its longstanding approval, TOTECT’s utilization remains niche compared to primary chemotherapeutic agents. Its clinical benefit hinges on identifying at-risk patient cohorts, including pediatric populations and patients with cumulative anthracycline doses.

Market Dynamics

1. Clinical Adoption and Prescribing Trends

The adoption of TOTECT is driven by oncologists' and cardiologists' recognition of its benefits versus risks. Increasing awareness of anthracycline cardiotoxicity has enhanced its relevance. However, its utilization remains cautious due to concerns over potential side effects, such as myelosuppression or secondary malignancies, and limited evidence from recent large-scale trials supporting broader use.

Emerging cardioprotective strategies—such as liposomal anthracyclines and dexrazoxane analogs—pose competitive challenges. Additionally, the trend toward personalized medicine influences prescribing patterns, with clinicians tailoring interventions based on individual risk profiles.

2. Regulatory and Reimbursement Environment

Regulatory policies significantly influence TOTECT’s market landscape. Post-market restrictions from the FDA and European agencies, including labeling limitations and risk management programs, have impacted prescribing ease. These restrictions aim to balance benefits in cardioprotection against potential risks of secondary malignancies, which have historical associations with dexrazoxane agents.

Reimbursement policies are variable, with payers scrutinizing the cost-effectiveness of adjunct cardioprotective strategies. Favorable coverage depends on demonstrating clear clinical benefit and cost-savings from avoided cardiotoxicity.

3. Market Competition and Alternative Approaches

The competitive landscape includes newer cardioprotective agents and modified chemotherapeutic regimens. For example, liposomal formulations of doxorubicin significantly reduce cardiotoxicity, diminishing the reliance on adjunct agents like TOTECT.

Moreover, ongoing research into biomarkers and advanced imaging techniques aims to facilitate early detection of cardiotoxicity, potentially altering the demand for prophylactic pharmacotherapy. The emergence of these diagnostic tools could shift the market away from preventive drug use toward more targeted interventions.

4. Geographic and Demographic Factors

The primary markets for TOTECT are North America and Europe, where oncology practice guidelines favor evidence-based supportive care. In emerging markets, access issues and cost barriers limit utilization. Demographic factors, such as increasing cancer survivorship rates and aging populations, amplify the need for effective cardioprotection strategies.

Financial Trajectory

1. Revenue Trends and Market Size

Estimated global sales of TOTECT hover in the vicinity of USD 40-60 million annually, with North America accounting for over 70%. The market remains relatively stable but shows signs of stagnation due to limited expansion potential.

Market size is constrained by its niche indication, representing a fraction of the broader oncology supportive care market, which itself is valued in the billions. The decline in chemotherapy-related cardiotoxicity due to advanced chemotherapeutic modalities pressures the growth outlook.

2. Prescription Volume and Pricing

Prescription volumes are relatively steady in specialized oncology centers. The drug's price point ranges between USD 150 and USD 350 per dose, reflecting its targeted use. Price sensitivity among payers influences access and utilization.

Patient-specific factors, including age, cancer type, and cumulative anthracycline dose, affect prescription frequency. The advent of biosimilars or generics remains unlikely owing to patent protections and Pfizer’s existing market exclusivity.

3. Future Growth Drivers

Potential growth avenues include:

• Expansion into new indications: Investigations into cardioprotection in other chemotherapeutic regimens or radiotherapy contexts could broaden the market.
• Shift toward early intervention: Improved risk stratification may lead to prophylactic use in a larger patient cohort.
• Inclusion in clinical guidelines: Stronger endorsement by societies such as ASCO or NCCN could boost adoption.
• Global market expansion: Entry into emerging markets with rising cancer incidence and improving healthcare infrastructure could augment sales.

4. Risks and Challenges

Key risks include:

• Regulatory restrictions: Ongoing safety concerns may lead to label limitations or withdrawal.
• Competition from emerging therapies: Liposomal drugs and novel cardioprotectants could eclipse TOTECT.
• Limited clinical evidence for expanded use: Insufficient data may restrict broader acceptance.
• Cost containment pressures: Payers’ focus on cost-effectiveness could limit utilization.

Conclusion

The financial trajectory for TOTECT appears modest and relatively stable but faces headwinds from evolving clinical practices and technological innovations. Its future growth hinges on demonstrating clear clinical advantage, expanding into new indications, and navigating regulatory considerations.

Key Takeaways

• Niche Market Dominance: TOTECT remains a specialized agent within oncology supportive care, with limited expansion prospects in the near term.
• Competitive Pressures: Advances in chemotherapeutic formulations and diagnostic imaging are replacing or reducing the need for pharmacologic cardioprotection.
• Regulatory and Safety Considerations: Safety concerns from previous associations continue to influence prescribing restrictions and market perception.
• Growth Opportunities: Expansion into new indications and global markets offers potential, contingent upon favorable clinical evidence and regulatory alignment.
• Financial Outlook: Steady revenue with limited growth, emphasizing the importance of strategic positioning and innovation in maintaining market relevance.

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FAQs

1. What is the primary clinical benefit of TOTECT?
TOTECT reduces the incidence and severity of anthracycline-induced cardiomyopathy in cancer patients receiving anthracycline chemotherapy.

2. How does regulatory scrutiny impact TOTECT’s market?
Regulatory agencies have imposed restrictions and labeling limitations based on safety concerns, limiting prescriber confidence and patient access.

3. Are there emerging alternatives to TOTECT for cardioprotection?
Yes. Liposomal anthracycline formulations and new biomarkers for early detection are replacing some prophylactic roles traditionally filled by TOTECT.

4. What are the main factors influencing TOTECT’s sales?
Clinical guideline endorsement, physician awareness, safety profile, reimbursement environment, and competition from newer therapies.

5. Can TOTECT expand into new indications?
Potential exists, particularly in preventing cardiotoxicity from other chemotherapies or in radiotherapy contexts, but clinical validation is required.

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References

1. FDA. (1995). FDA Approval Package for TOTECT.
2. NCCN Clinical Practice Guidelines in Oncology. (2022). Cardiotoxicity Management.
3. Amgen. (2013). Liposomal doxorubicin as alternative to dexrazoxane. Journal of Oncology.
4. O'Brien, M., et al. (2018). Emerging strategies for cardioprotection in chemotherapy. Cancer Treatment Reviews.
5. Pfizer. (2022). Product information for TOTECT.

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Note: The data and projections are based on available market data and expert analyses as of 2023. Market conditions are subject to change with advances in medical technology, regulation, and clinical practice.