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Last Updated: May 18, 2025

Drugs in MeSH Category Topoisomerase I Inhibitors


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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teyro Labs TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091199-001 Dec 1, 2010 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novast Labs TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 206962-001 Nov 30, 2016 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fresenius Kabi Usa TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091376-001 Nov 29, 2010 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Accord Hlthcare TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 204406-001 Jul 6, 2017 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Meitheal TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 201166-001 Aug 8, 2012 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Meitheal TOPOTECAN HYDROCHLORIDE topotecan hydrochloride SOLUTION;INTRAVENOUS 022453-001 Dec 20, 2012 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fresenius Kabi Usa TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091089-001 Nov 29, 2010 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

Topoisomerase I Inhibitors Market Analysis and Financial Projection

The market dynamics and patent landscape for Topoisomerase I (Topo I) inhibitors reflect a rapidly evolving oncology therapeutics sector driven by innovation and increasing clinical demand. Below is a structured analysis:


Market Dynamics

The global Topo I inhibitors market is projected to grow from $7 billion in 2023 to $12+ billion by 2030, at a CAGR of 6.5–9.3%[1][7]. Key drivers include:

  • Rising cancer prevalence: Solid tumors, leukemia, and ovarian cancers drive demand for chemotherapeutics like irinotecan and topotecan.
  • Advancements in targeted therapies: Biomarker-driven approaches and antibody-drug conjugates (ADCs) such as Trastuzumab deruxtecan (Enhertu) enhance drug efficacy while reducing systemic toxicity[10].
  • Regional growth: North America (35–40% market share) and Europe dominate due to high healthcare spending, while Asia-Pacific shows rapid expansion with a CAGR of ~8%[4][7].

Key Players:

  • Roche and Novartis lead with oncology portfolios exceeding $60 billion in annual revenue[1].
  • Emerging competitors include Daiichi Sankyo and Servier Laboratories, focusing on novel formulations like nanoparticle-delivered Topo I inhibitors[4][10].

Challenges: Drug resistance (e.g., camptothecin derivatives) and side effects (e.g., myelosuppression) remain hurdles[12][13].


Patent Landscape

Topo I inhibitor patents surged post-2016, with notable trends:

Innovation Areas

Focus Examples Key Players
Prodrugs Polymer-conjugated inhibitors for targeted delivery Academia, small biotech firms[2]
Combination Dual-action agents (e.g., Topo I + PARP inhibitors) Novartis, Merck KGaA[3][8]
Non-CPT Agents Indenoisoquinolines, synthetic pyridines NIH (LMP-776), Pfizer[3][13]
  • Recent Patents:
    • US20210246128A1: Bicycle-shaped Topo I inhibitors with reduced off-target effects[8].
    • Antibody-drug conjugates (ADCs): Over 500 patents filed for Topo I payloads (e.g., SN-38 in Sacituzumab govitecan)[10].

Collaborations and Competition

  • Academic contributions: ~60% of patents originate from universities and startups[2][12].
  • Strategic alliances: Pfizer’s partnerships with biotechs aim to expand indications (e.g., glioblastoma)[12].

Future Outlook

  1. Pipeline Drugs: 233 molecules in development, including dual Topo I/II inhibitors and agents targeting infectious diseases[12].
  2. Technological Shifts: CRISPR-based screening for synthetic lethality and AI-driven drug design to overcome resistance[9][12].
  3. Market Expansion: Growth in low-middle-income countries and non-oncology applications (e.g., antiviral therapies)[2][12].

"The highest contribution toward patent development has been obtained from academics or small biotechnology companies." [2]

This dynamic interplay of market demand, strategic R&D, and intellectual property innovation positions Topo I inhibitors as a cornerstone of next-generation oncology therapeutics.

References

  1. https://github.com/khifzaba/Market-Research-Report-List-1/blob/main/topoisomerase-inhibitors-market.md
  2. https://pubmed.ncbi.nlm.nih.gov/33475439/
  3. https://pubmed.ncbi.nlm.nih.gov/27450102/
  4. https://www.qyresearch.com/reports/4353077/topoisomerase-i-inhibitors
  5. https://ipwatchdog.com/2017/08/10/immunotherapy-patent-landscape-patent-claims-immunotherapeutic-inventions/id=86634/
  6. http://eprints-phd.biblio.unitn.it/2717/1/PhD_thesis_Lal_Preet.pdf
  7. https://www.databridgemarketresearch.com/reports/global-topoisomerase-inhibitors-market
  8. https://patents.google.com/patent/US20210246128A1/en
  9. https://en.wikipedia.org/wiki/Topoisomerase_inhibitor
  10. https://www.biochempeg.com/article/376.html
  11. https://meshb.nlm.nih.gov/record/ui?ui=D002166
  12. https://uu.diva-portal.org/smash/get/diva2:1905889/FULLTEXT01.pdf
  13. https://academic.oup.com/nar/article/41/22/10010/2437309
Last updated: 2025-03-24

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