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Last Updated: April 20, 2025

Mechanism of Action: Serotonin 3 Receptor Antagonists


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Drugs with Mechanism of Action: Serotonin 3 Receptor Antagonists

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes 10,233,154 ⤷  Try for Free Y ⤷  Try for Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes 10,208,073 ⤷  Try for Free ⤷  Try for Free
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes 9,186,357 ⤷  Try for Free ⤷  Try for Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493-001 Apr 19, 2018 DISCN Yes No 12,208,109 ⤷  Try for Free Y ⤷  Try for Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes 10,717,721 ⤷  Try for Free Y ⤷  Try for Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493-001 Apr 19, 2018 DISCN Yes No 10,208,073 ⤷  Try for Free ⤷  Try for Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes 10,828,297 ⤷  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
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Serotonin 3 Receptor Antagonists Market Analysis and Financial Projection

The market for Serotonin 3 (5-HT3) Receptor Antagonists is experiencing steady growth driven by clinical demand and expanding therapeutic applications, while the patent landscape reflects intense competition and innovation across new indications and formulations. Below is a detailed analysis:


Market Dynamics

Market Size and Growth

The global 5-HT3 receptor antagonists market is projected to grow from $6.3 billion in 2026 (CAGR 5.7%) [1] to $10.78 billion by 2037 (CAGR ~5.6%) [7], fueled by rising cancer prevalence and chemotherapy/radiation therapy adoption. Another estimate suggests the market could reach $7.2 billion by 2033 with a 6.5% CAGR [3]. Growth drivers include:

  • Cancer chemotherapy-induced nausea and vomiting (CINV): Over 1.9 million new U.S. cancer cases in 2022 [3], requiring antiemetic therapies.
  • Cost-effectiveness of first-generation drugs: Ondansetron costs $1.87 per 5mL vs. $8.78 for second-generation palonosetron [1].
  • Surgical/post-operative applications: Hospital pharmacies dominate distribution due to procedural volume [7].

Market Segmentation

  • By generation: First-generation (ondansetron) Second-generation (palonosetron)
    61% market share (2020) [1] Fastest-growing segment (6.1% CAGR) [1]
    Lower cost, oral availability Stronger receptor binding, longer efficacy [1]
  • By indication: Chemotherapy-induced nausea (dominant), post-operative nausea (fastest-growing) [7].

Competitive Landscape

Key players include GlaxoSmithKline, Sanofi, and Roche, with strategies focused on product launches (e.g., Helsinn’s IV formulation for CINV in 2020 [1]) and geographic expansion. Second-generation drugs like palonosetron are gaining traction for severe tumors [8].


Patent Landscape

Key Trends and Innovations

  1. New Therapeutic Indications:

    • Alcohol/Opioid Use Disorders: Adial Pharmaceuticals patented AD04 (a 5-HT3 antagonist) for genetically biomarker-defined patients [2].
    • Vestibular Deficits: European Patent EP2253316A1 covers 5-HT3 antagonists for balance disorders [6].
    • Airway Constriction: WO2001095903A1 claims 5-HT3 antagonists for asthma and COPD [10].
  2. Formulation Advances:

    • Extended-release injectables (e.g., Helsinn’s 2020 IV drug [1]) and combination therapies to reduce dosing frequency [3].
  3. Genetic Targeting:

    • Patents emphasize biomarker-driven therapies, such as Adial’s focus on serotonin transporter gene variants [2].

Regional and Strategic Insights

  • China leads in patent filings, followed by the U.S. and Japan, with 106 drugs in global development [8][15].
  • Small molecules dominate (87% of pipeline drugs), focusing on nausea/vomiting, IBS, and psychiatric disorders [4][13].
  • Challenges: Side effects (arrhythmia, serotonin syndrome [1]) and regulatory hurdles for novel indications [13].

Future Outlook

  • Emerging Markets: Low/medium-HDI countries drive first-generation drug demand due to affordability [1].
  • R&D Focus: Over 10+ companies are developing next-gen antagonists targeting chemotherapy-resistant CINV and neurological conditions [13].
  • Patent Strategies: Companies are securing IP for subpopulation targeting (e.g., genetic biomarkers [2]) and drug-delivery systems [3].

“The approval of palonosetron in multiple countries highlights its global significance in addressing unmet needs in antiemetic care.” – Patsnap Synapse Analysis [8]

This landscape underscores a balance between cost-effective first-line therapies and high-innovation second-generation drugs, with patents increasingly leaning toward precision medicine and multifunctional applications.

References

  1. https://www.industryarc.com/Report/19738/5ht3-receptor-antagonists-market.html
  2. https://www.adial.com/adial-pharmaceuticals-awarded-u-s-and-international-patents-for-the-treatment-of-alcohol-and-opioid-use-disorders-using-ad04/
  3. https://www.verifiedmarketreports.com/product/5ht3-receptor-antagonists-market/
  4. https://synapse.patsnap.com/blog/deciphering-5-ht3-receptor-antagonists-and-keeping-up-with-their-recent-developments
  5. https://www.datainsightsmarket.com/reports/hydroxytryptamine-receptor-575624
  6. https://patents.google.com/patent/EP2253316A1/en
  7. https://www.researchnester.com/reports/5-ht3-receptor-antagonists-market/3301
  8. https://synapse.patsnap.com/blog/anti-emetic-agent-5-ht3-antagonist
  9. https://patents.google.com/patent/EP1798227A4/en
  10. https://patents.google.com/patent/WO2001095903A1/en
  11. https://www.sternekessler.com/news-insights/publications/navigating-the-psychedelic-patent-landscape-trends-challenges-and-future-directions/
  12. https://patents.google.com/patent/WO2011008572A2/en
  13. https://www.researchandmarkets.com/reports/5321307/serotonin-3-receptor-antagonists-pipeline
  14. https://www.sternekessler.com/app/uploads/2024/12/Navigating-the-psychedelic-patent-landscape-Trends-challenges-and-future-directions.pdf
  15. https://synapse.patsnap.com/target/a871183ecd7c39ffa9a403a0be019283

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