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

Last Updated: January 7, 2025

TOPOTECAN HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Topotecan Hydrochloride, and what generic alternatives are available?

Topotecan Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Novast Labs, Rising, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Dash Pharms, and Hospira Inc. and is included in fifteen NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Topotecan Hydrochloride

A generic version of TOPOTECAN HYDROCHLORIDE was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29th, 2010.

  Subscribe

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

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

SponsorPhase
GOG FoundationPhase 3
Verastem, Inc.Phase 3
Luye Pharma Group Ltd.Phase 3

See all TOPOTECAN HYDROCHLORIDE clinical trials

Pharmacology for TOPOTECAN HYDROCHLORIDE
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for TOPOTECAN HYDROCHLORIDE

US Patents and Regulatory Information for TOPOTECAN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 202351-001 Jun 26, 2013 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novast Labs TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 206962-001 Nov 30, 2016 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091089-001 Nov 29, 2010 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 204406-001 Jul 6, 2017 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091542-001 Aug 28, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meitheal TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 022453-001 Dec 20, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dash Pharms TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 206074-001 Nov 24, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TOPOTECAN HYDROCHLORIDE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Topotecan Hydrochloride

Introduction to Topotecan Hydrochloride

Topotecan hydrochloride is a chemotherapeutic agent that functions as a topoisomerase I inhibitor, disrupting DNA replication and leading to cancer cell death. It is primarily used in the treatment of various cancers, including ovarian and small cell lung cancer.

Global Market Size and Growth

The global Topotecan Hydrochloride Sales Market is projected to be USD 572.6 million in 2024. This market is expected to expand at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031, reaching USD 805.70 million by 2031[1].

Regional Market Breakdown

  • North America: This region holds the largest share of the global market, with a market size of USD 229.04 million in 2024. It is expected to grow at a CAGR of 3.2% from 2024 to 2031[1].
  • Europe: Europe accounts for more than 30% of the global revenue, with a market size of USD 171.78 million in 2024, and is expected to grow at a CAGR of 3.5% from 2024 to 2031[1].
  • Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 131.70 million in 2024, and is expected to grow at a CAGR of 7.0% from 2024 to 2031[1].
  • Latin America: The Latin American market accounts for more than 5% of the global revenue, with a market size of USD 28.63 million in 2024, and is expected to grow at a CAGR of 4.4% from 2024 to 2031[1].
  • Middle East and Africa: This region holds around 2% of the global revenue, with a market size of USD 11.45 million in 2024, and is expected to grow at a CAGR of 4.7% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the topotecan hydrochloride market:

  • Increasing Cancer Prevalence: The rising incidence of cancers such as ovarian and small cell lung cancer is a significant driver. As the global population ages and lifestyle factors contribute to higher cancer rates, the demand for effective treatments like topotecan hydrochloride increases[1].
  • Advancements in Drug Formulations: Innovations in drug delivery systems, such as nanoencapsulation and targeted therapies, are enhancing the efficacy and safety of topotecan hydrochloride. For example, nanoformulations have shown improved cytotoxicity and better therapeutic outcomes[3].
  • Investments in Oncology Research: Increased investments in oncology research are leading to better understanding and treatment of cancers, further boosting the market for topotecan hydrochloride[1].

Clinical Effectiveness and Cost-Effectiveness

Clinical trials and economic evaluations have assessed the effectiveness and cost-effectiveness of topotecan hydrochloride compared to other chemotherapy agents. For instance, a systematic review and economic evaluation found that for patients with platinum-sensitive ovarian cancer, paclitaxel plus platinum could be considered cost-effective compared to platinum alone. However, the cost-effectiveness of topotecan in certain scenarios, especially for platinum-resistant/refractory disease, is less clear and often not favorable[2].

Nanoenabled Delivery Systems

The use of nanoenabled active and passive targeting strategies is a significant trend in the delivery of topotecan hydrochloride. These systems leverage the enhanced permeability and retention (EPR) effect to accumulate at tumor sites, improving the drug's therapeutic efficacy and reducing side effects. Active targeting using specific ligands to over-expressed receptors on tumor cells further enhances the drug's delivery and effectiveness[3].

Combinatorial Drug Therapy

Combinatorial drug therapy employing topotecan hydrochloride is another area of research. Studies have shown that combining topotecan with other drugs can improve therapeutic outcomes. For example, combining topotecan with tamoxifen in polymeric nanoparticles has shown potential in preclinical studies[3].

Clinical Trials and Future Perspectives

Ongoing clinical trials are exploring new combinations and delivery methods for topotecan hydrochloride. For instance, a phase I trial is testing the safety and efficacy of tazemetostat in combination with topotecan and pembrolizumab in patients with small cell lung cancer[5].

Market Segmentation

The topotecan hydrochloride market is segmented based on type (Type I, Type II, Type III, Type IV) and application (injection, capsule), as well as geographical regions. This segmentation helps in understanding the specific needs and trends in different markets[4].

Key Players

Several companies are key players in the topotecan hydrochloride market, including Ark Pharm, Wilshire Technologies, ChemFaces, Boc Sciences, and CAYMAN CHEMICAL. These companies are involved in the production, research, and development of topotecan hydrochloride and its formulations[4].

Financial Projections

The financial trajectory of the topotecan hydrochloride market is positive, with steady growth projected over the next several years. The market's expansion is driven by increasing demand, advancements in technology, and ongoing research and development.

"The global Topotecan Hydrochloride Sales Market size will be USD 572.6 million in 2024 and will expand at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031, reaching USD 805.70 million by 2031"[1].

Challenges and Limitations

Despite the positive growth trajectory, there are challenges and limitations. The cost-effectiveness of topotecan hydrochloride in certain scenarios is a concern, and the comparative clinical effectiveness and cost-effectiveness of different chemotherapy regimens need further clarification through randomized controlled trials[2].

Key Takeaways

  • The global topotecan hydrochloride market is expected to grow from USD 572.6 million in 2024 to USD 805.70 million by 2031.
  • North America holds the largest market share, followed by Europe and Asia Pacific.
  • Increasing cancer prevalence, advancements in drug formulations, and investments in oncology research are key drivers.
  • Nanoenabled delivery systems and combinatorial drug therapies are enhancing the therapeutic efficacy of topotecan hydrochloride.
  • Ongoing clinical trials are exploring new combinations and delivery methods.

FAQs

1. What is the primary use of topotecan hydrochloride?

Topotecan hydrochloride is primarily used in the treatment of various cancers, including ovarian and small cell lung cancer, by inhibiting topoisomerase I and disrupting DNA replication.

2. What is the projected global market size for topotecan hydrochloride in 2031?

The global topotecan hydrochloride market is expected to reach USD 805.70 million by 2031, growing at a CAGR of 5.00% from 2024 to 2031[1].

3. Which region holds the largest share of the topotecan hydrochloride market?

North America holds the largest share of the global topotecan hydrochloride market, with a market size of USD 229.04 million in 2024[1].

4. How are nanoenabled delivery systems improving the efficacy of topotecan hydrochloride?

Nanoenabled delivery systems, such as nanoencapsulation, leverage the enhanced permeability and retention (EPR) effect to accumulate at tumor sites, improving the drug's therapeutic efficacy and reducing side effects[3].

5. What are some of the key challenges in the topotecan hydrochloride market?

Challenges include the cost-effectiveness of topotecan hydrochloride in certain scenarios and the need for further clarification on the comparative clinical effectiveness and cost-effectiveness of different chemotherapy regimens through randomized controlled trials[2].

Cited Sources:

  1. Cognitive Market Research, "Topotecan Hydrochloride Sales Market Report 2024 (Global Edition)".
  2. PubMed, "A systematic review and economic evaluation".
  3. MDPI, "Nanoplatform for the Delivery of Topotecan in the Cancer Milieu".
  4. Market Research Intellect, "Global Topotecan Hydrochloride Market Size And Forecast".
  5. National Cancer Institute, "Clinical Trials Using Topotecan Hydrochloride".

More… ↓

⤷  Subscribe

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.