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Last Updated: December 22, 2024

TOPOTECAN Drug Patent Profile


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When do Topotecan patents expire, and when can generic versions of Topotecan launch?

Topotecan is a drug marketed by Sandoz Inc, 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 sixteen NDAs.

The generic ingredient in TOPOTECAN 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

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

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Summary for TOPOTECAN
US Patents:0
Applicants:13
NDAs:16
Raw Ingredient (Bulk) Api Vendors: 93
Clinical Trials: 438
Patent Applications: 2,067
Drug Prices: Drug price information for TOPOTECAN
What excipients (inactive ingredients) are in TOPOTECAN?TOPOTECAN excipients list
DailyMed Link:TOPOTECAN at DailyMed
Drug patent expirations by year for TOPOTECAN
Drug Prices for TOPOTECAN

See drug prices for TOPOTECAN

Recent Clinical Trials for TOPOTECAN

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 clinical trials

US Patents and Regulatory Information for TOPOTECAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc TOPOTECAN topotecan hydrochloride SOLUTION;INTRAVENOUS 200199-001 Feb 25, 2011 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira Inc TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 200582-001 Feb 2, 2011 AP RX Yes Yes ⤷  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 INJECTABLE;INJECTION 202351-001 Jun 26, 2013 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sagent Pharms TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091284-001 Jan 26, 2011 AP RX 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Topotecan Hydrochloride

Introduction

Topotecan hydrochloride, a chemotherapeutic agent, is primarily used in the treatment of various cancers, including ovarian and small cell lung cancer. It functions as a topoisomerase I inhibitor, disrupting DNA replication and leading to cancer cell death. Here, we delve into the market dynamics and financial trajectory of topotecan hydrochloride, highlighting its current market size, growth prospects, regional performance, and key driving factors.

Current Market Size and Growth Prospects

The global topotecan hydrochloride market is substantial and growing. As of 2024, the market size is estimated to be USD 572.6 million. This market is projected 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 Performance

The market for topotecan hydrochloride is geographically diverse, with different regions exhibiting varying growth rates.

North America

North America holds the largest share of the global market, accounting for more than 40% of the global revenue with a market size of USD 229.04 million in 2024. This region is expected to grow at a CAGR of 3.2% from 2024 to 2031[1].

Europe

Europe is the second-largest market, holding more than 30% of the global revenue with a market size of USD 171.78 million in 2024. The European market is projected to grow at a CAGR of 3.5% during the same period[1].

Asia-Pacific

The Asia-Pacific region is expected to expand at the fastest CAGR, driven by increasing cancer prevalence, improving healthcare infrastructure, and rising investments in medical research. This region accounted for 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 and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, though to a lesser extent. Latin America held around 5% of the global revenue with a market size of USD 28.63 million in 2024, expected to grow at a CAGR of 4.4%. The Middle East & Africa accounted for around 2% with a market size of USD 11.45 million in 2024, expected to grow at a CAGR of 4.7% from 2024 to 2031[1].

Key Driving Factors

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

Rising Cancer Prevalence

The increasing incidence of cancers, particularly 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 is rising[1][4].

Advancements in Drug Formulations

Advancements in drug formulations and the introduction of novel drug delivery systems are enhancing the efficacy and patient compliance of topotecan hydrochloride. These innovations are expected to further boost market growth[1].

Increased Investments in Oncology Research

Increased investments in oncology research and the growing demand for personalized medicine and targeted therapies are also driving the market expansion. Ongoing clinical trials and research into new dosing strategies, such as extended exposure topotecan, are promising areas of development[1][5].

Clinical Effectiveness and Cost-Effectiveness

Topotecan has been shown to be clinically effective, particularly in the treatment of small cell lung cancer.

Clinical Effectiveness

Studies have indicated that topotecan is better than best supportive care (BSC) alone in terms of improved survival and is as effective as other chemotherapy regimens like CAV (cyclophosphamide, Adriamycin, and vincristine). However, it is less favorable than intravenous amrubicin in terms of response rates[2].

Cost-Effectiveness

While topotecan offers additional benefits over BSC, it comes at an increased cost. The incremental cost-effectiveness ratio (ICER) for oral topotecan is at the upper extreme of the range conventionally regarded as cost-effective, and ICERs for intravenous topotecan are even higher, suggesting it may not be a cost-effective option in all scenarios[2].

Extended Exposure Topotecan

Recent studies have explored the benefits of extended exposure (EE) topotecan, which involves administering the drug at a lower dose over a longer period. This approach has been shown to maintain drug potency and reduce the development of drug resistance compared to the maximum tolerable dose (MTD) approach[5].

Market Players

The topotecan hydrochloride market is dominated by several key players, including Boc Sciences, CAYMAN CHEMICAL, ChemFaces, Wilshire Technologies, and Ark Pharm. These companies are involved in the production and distribution of topotecan hydrochloride and are driving the market through their research and development efforts[4].

Future Outlook

The future outlook for the topotecan hydrochloride market is positive, driven by the increasing demand for cancer treatments and advancements in drug delivery systems. The market is expected to continue growing, with significant contributions from the Asia-Pacific region.

Key Takeaways

  • The global topotecan hydrochloride market size is estimated to be USD 572.6 million in 2024 and is expected to reach USD 805.70 million by 2031.
  • The market is driven by rising cancer prevalence, advancements in drug formulations, and increased investments in oncology research.
  • Asia-Pacific is projected to be the fastest-growing region.
  • Topotecan has been shown to be clinically effective but comes with higher costs compared to some other treatments.
  • Extended exposure topotecan is a promising approach to maintain drug potency and reduce resistance.

FAQs

What is the current market size of the global topotecan hydrochloride market?

The global topotecan hydrochloride market size is estimated to be USD 572.6 million in 2024[1].

What is the projected CAGR of the topotecan hydrochloride market from 2024 to 2031?

The market is expected to grow at a CAGR of 5.00% from 2024 to 2031[1].

Which region is expected to grow the fastest in the topotecan hydrochloride market?

The Asia-Pacific region is projected to expand at the fastest CAGR, driven by increasing cancer prevalence and improving healthcare infrastructure[1].

What are the key driving factors of the topotecan hydrochloride market?

The key driving factors include rising cancer prevalence, advancements in drug formulations, and increased investments in oncology research[1][4].

Is topotecan hydrochloride cost-effective compared to other treatments?

Topotecan offers additional benefits over best supportive care but at an increased cost. The cost-effectiveness varies depending on the administration method, with oral topotecan being more cost-effective than intravenous topotecan[2].

Sources

  1. Cognitive Market Research: Topotecan Hydrochloride Sales Market Report 2024 (Global Edition)[1].
  2. PubMed: The clinical effectiveness and cost-effectiveness of topotecan for small cell lung cancer[2].
  3. Dataintelo: Topotecan Hydrochloride Market Research Report 2032[3].
  4. Business Research Insights: Topotecan Hydrochloride Market Size | Global Report -2032[4].
  5. MDPI: Extended Exposure Topotecan Significantly Improves Long-Term Drug Sensitivity by Decreasing Malignant Cell Heterogeneity and by Preventing Epithelial–Mesenchymal Transition[5].

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