You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 2, 2025

DEXRAZOXANE HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

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

The generic ingredient in DEXRAZOXANE HYDROCHLORIDE is dexrazoxane hydrochloride. There are six drug master file entries 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 28th, 2004.

  Try for Free

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for DEXRAZOXANE HYDROCHLORIDE?
  • What are the global sales for DEXRAZOXANE HYDROCHLORIDE?
  • What is Average Wholesale Price for DEXRAZOXANE HYDROCHLORIDE?
Drug patent expirations by year for DEXRAZOXANE HYDROCHLORIDE
Recent Clinical Trials for DEXRAZOXANE HYDROCHLORIDE

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

SponsorPhase
Ain Shams UniversityPhase 2/Phase 3
Maria Sklodowska-Curie National Research Institute of OncologyPhase 3
Polish Medical Research AgencyPhase 3

See all DEXRAZOXANE HYDROCHLORIDE clinical trials

Pharmacology for DEXRAZOXANE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DEXRAZOXANE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DEXRAZOXANE HYDROCHLORIDE

US Patents and Regulatory Information for DEXRAZOXANE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 076068-001 Sep 28, 2004 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 076068-002 Sep 28, 2004 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eugia Pharma DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 200752-001 Oct 19, 2011 AP RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eugia Pharma DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 200752-002 Oct 19, 2011 AP RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Gland DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 207321-001 Nov 28, 2016 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Gland DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 207321-002 Dec 16, 2019 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory of Dexrazoxane Hydrochloride

Introduction to Dexrazoxane Hydrochloride

Dexrazoxane hydrochloride is a cardioprotective drug that plays a crucial role in protecting the heart from the cardiotoxic adverse effects of chemotherapeutic agents, particularly anthracyclines such as doxorubicin and daunorubicin. It is approved by the US FDA for the prevention of cardiomyopathy in adults and children aged 0 to 16 years undergoing anthracycline treatment[4][5].

Market Drivers

Increasing Prevalence of Cancer

The global rise in cancer cases is a significant driver for the dexrazoxane market. As the number of cancer patients increases, so does the use of anthracyclines, which in turn increases the demand for dexrazoxane to mitigate the cardiotoxic effects of these chemotherapy agents[1][4].

Advances in Healthcare

Advancements in healthcare, particularly in oncology, have led to an increased adoption of dexrazoxane in clinical practice. This shift towards using dexrazoxane is driven by its efficacy in reducing cardiotoxicity associated with anthracycline therapy, thereby improving patient outcomes[1][4].

Regulatory Approvals and Market Expansion

Key regulatory approvals and market launches have also driven the growth of the dexrazoxane market. For instance, Hikma Pharmaceuticals launched a generic version of dexrazoxane for injections in 2018, and Cumberland Pharmaceuticals initiated the promotion of Totect® (dexrazoxane hydrochloride) in the US in 2017[1][2].

Market Segmentation

By Product Type

The dexrazoxane market is segmented into two primary product types: 250mg and 500mg. These different dosages cater to various patient needs and treatment protocols[1][4].

By End User

The market is segmented by end users into hospitals and drugstores. Hospitals are expected to have the largest CAGR during the forecast period due to their direct involvement in cancer treatment and the presence of in-house pharmacies[1][4].

Regional Analysis

Global Market Distribution

The dexrazoxane market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe hold significant shares due to the presence of advanced cancer treatment institutions and well-established healthcare facilities[1][4].

Emerging Markets

Latin America and Asia Pacific regions are predicted to exhibit vital growth during the forecast period. Government initiatives to improve healthcare infrastructure in countries like China and India are expected to contribute significantly to the expansion of the dexrazoxane market[1][4].

Financial Trajectory

Market Size and Forecast

The global dexrazoxane market was valued at a significant amount in 2022 and is anticipated to grow at a substantial CAGR over the forecast period (2023-2029 or 2031). The market is expected to reach a higher value by the end of the forecast period, driven by the increasing demand for cardioprotective agents in oncology[3][4].

Revenue and Growth Projections

The market's financial trajectory is positive, with a significant increase in revenue projected due to the rising incidence of cancer and the consequent increase in the use of anthracyclines. The CAGR for the dexrazoxane market is expected to be high, reflecting the growing need for this drug in clinical settings[1][3].

Challenges and Opportunities

Side Effects and Dosage Concerns

Despite the growth drivers, the market faces challenges such as high dosages leading to side effects, which can hamper market growth. However, ongoing research and advancements in formulation and delivery methods are expected to mitigate these issues[4].

Competitive Landscape

The dexrazoxane market is characterized by a competitive landscape with key players such as Hikma Pharmaceuticals, Cumberland Pharmaceuticals, and Clinigen. These companies are focusing on organic and inorganic growth strategies, including product launches, acquisitions, and partnerships, to expand their market share[1][2][4].

Key Players and Market Strategies

Product Launches and Acquisitions

Companies like Cumberland Pharmaceuticals have launched promotional campaigns for their dexrazoxane products, such as Totect®, to increase market penetration. Clinigen's acquisition of Totect® in 2016 is another example of strategic moves to strengthen market presence[2][4].

SWOT Analysis

Key players in the market are analyzed through SWOT analysis, highlighting their strengths, weaknesses, opportunities, and threats. This analysis helps in understanding their market strategies and competitive positioning[4].

Conclusion

The dexrazoxane hydrochloride market is poised for significant growth driven by the increasing prevalence of cancer, advances in healthcare, and regulatory approvals. While challenges such as side effects exist, ongoing research and competitive strategies by key players are expected to drive the market forward.

Key Takeaways

  • Increasing Cancer Prevalence: Rising cancer cases globally drive the demand for dexrazoxane.
  • Healthcare Advances: Improved healthcare facilities and adoption of dexrazoxane in clinical practice boost market growth.
  • Regulatory Approvals: Key launches and approvals, such as Totect® and generic versions, expand market reach.
  • Regional Growth: North America and Europe lead, with Latin America and Asia Pacific showing promising growth.
  • Financial Projections: Significant CAGR and revenue growth expected over the forecast period.

FAQs

What is dexrazoxane hydrochloride used for?

Dexrazoxane hydrochloride is used to protect the heart from cardiotoxic effects of chemotherapeutic agents like anthracyclines and to treat extravasation caused by intravenous anthracyclines[5].

Which regions dominate the dexrazoxane market?

North America and Europe currently hold significant shares of the global dexrazoxane market, with Latin America and Asia Pacific expected to show substantial growth[1][4].

What are the key drivers of the dexrazoxane market?

The key drivers include the increasing prevalence of cancer, advances in healthcare, and regulatory approvals for dexrazoxane products[1][4].

Which companies are major players in the dexrazoxane market?

Major players include Hikma Pharmaceuticals, Cumberland Pharmaceuticals, and Clinigen, among others[1][2][4].

What are the challenges facing the dexrazoxane market?

High dosages leading to side effects are a significant challenge, although ongoing research and advancements are expected to address these issues[4].

Sources

  1. Research and Markets: Global Dexrazoxane Market Outlook 2028.
  2. PR Newswire: Cumberland Pharmaceuticals Launches Promotion of Totect® in the US.
  3. Valuates Reports: Global Dexrazoxane Market Research Report 2023.
  4. The Insight Partners: Dexrazoxane Market Key Players Analysis 2031.
  5. National Cancer Institute: Dexrazoxane Hydrochloride.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.