Drugs in MeSH Category Serotonin 5-HT2 Receptor Antagonists

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No					Y
Aurobindo Pharma Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208045-001	Mar 10, 2023	AB	RX	No	No
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	AB	RX	Yes	No			Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No					Y
Watson Labs Teva	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208016-004	Feb 2, 2021		DISCN	No	No
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	AB	RX	Yes	No
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015		RX	Yes	Yes

Serotonin 5-HT2 Receptor Antagonists Market Analysis and Financial Projection

The market for serotonin 5-HT2 receptor antagonists is evolving rapidly, driven by expanding therapeutic applications, patent innovations, and increasing demand for treatments targeting neurological and psychiatric disorders. Here's a detailed analysis:

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Market Growth and Drivers

• Projected Expansion: The broader 5-hydroxytryptamine receptor market, which includes 5-HT2 antagonists, is projected to grow from $1.2 billion in 2024 to $2.5 billion by 2033, with a CAGR of 9.2%[4]. This growth is fueled by rising mental health disorders, such as schizophrenia, depression, and Parkinson’s disease psychosis[4][14].
• Key Therapeutic Areas:
  • Neuropsychiatric Disorders: Pimavanserin, a 5-HT2A inverse agonist, is FDA-approved for hallucinations in Parkinson’s psychosis[14].
  • Oncology Support: 5-HT3 antagonists (a related class) dominate the $6.3 billion antiemetic market for chemotherapy-induced nausea, illustrating the broader potential of serotonin modulators[12].
  • Emerging Applications: 5-HT2B receptor antagonists are being explored for fibrosis, gastrointestinal disorders, and cancer[10].

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Patent Landscape and Innovation

• Recent Developments:
  • 2A Biosciences patented novel 5-HT2A/2C agonists in 2024 for conditions like Crohn’s disease, schizophrenia, and traumatic brain injury[2].
  • Tricyclic Derivatives: Patents like AU2020295685A1 cover new tricyclic compounds targeting 5-HT2 receptors[7], while EP3109237A1 (withdrawn) focused on 5-HT2B antagonists[9].
• Challenges in Selectivity: High homology between 5-HT2A and 5-HT2C receptors complicates drug design, leading to non-selective agents like LSD. Advances in receptor crystallography are aiding selective compound development[1][10].

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Competitive Pressures and Generics

• Patent Expiries: The looming expiration of key patents (e.g., ondansetron for 5-HT3 in 2006[5]) highlights the impact of generics. However, "supergenerics" with improved formulations (e.g., nanoparticle-bound paclitaxel) are mitigating revenue loss[5].
• Clinical Setbacks: Several 5-HT2A antagonists, including volinanserin and pruvanserin, were discontinued due to inadequate efficacy[6][17], underscoring the high risk in drug development.

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Regional Dynamics

• Asia-Pacific Dominance: Holds the largest market share due to high cancer prevalence and chemotherapy adoption[12].
• North American Innovation: Leading in R&D, with companies like Acadia Pharmaceuticals advancing 5-HT2A agents (e.g., pimavanserin)[14].

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Future Outlook

• Personalized Medicine: Genetic profiling and biased signaling research (e.g., 5-HT2B in pancreatic cancer[10]) are opening avenues for targeted therapies.
• Collaborative R&D: Partnerships between biotech firms and academia aim to overcome selectivity hurdles and explore novel indications like fibrotic diseases[10].

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Highlight: "The global 5-hydroxytryptamine receptor market is expected to double by 2033, with 5-HT2 antagonists playing a pivotal role in neurology and oncology"[4].

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Key Takeaways:

• Market growth is robust but hinges on overcoming receptor selectivity and clinical attrition.
• Patent filings remain active, with a focus on polypharmacology (targeting multiple 5-HT subtypes) and novel formulations.
• Regional expansion in Asia-Pacific and therapeutic diversification into fibrosis/cancer will shape future dynamics.

References

1. https://www.jneurosci.org/content/43/45/7472
2. https://www.bioworld.com/articles/712559-new-5-ht2a-and-5-ht2c-receptor-agonists-disclosed-in-2a-biosciences-patent
3. https://pubmed.ncbi.nlm.nih.gov/9401775/
4. https://www.verifiedmarketreports.com/product/5-hydroxytryptamine-receptor-market/
5. https://www.ufrgs.br/imunovet/molecular_immunology/anticancer.html
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC3630942/
7. https://patents.google.com/patent/AU2020295685A1/en
8. https://pubmed.ncbi.nlm.nih.gov/9877220/
9. https://patents.google.com/patent/EP3109237A1/en
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC7909583/
11. https://patents.google.com/patent/WO2002036113A1/en
12. https://www.industryarc.com/Report/19738/5ht3-receptor-antagonists-market.html
13. https://patents.justia.com/patent/20030083325
14. https://www.businesswire.com/news/home/20210310005551/en/Pimavanserin-A-Selective-Serotonin-Inverse-Agonist-and-Antagonist-Preferentially-Targeting-5-HT2A-Receptors---Global-Emerging-Insights-and-Market-Forecast-to-2030---ResearchAndMarkets.com
15. https://patents.google.com/patent/US9801856B2/en
16. https://patents.google.com/patent/US20030083325A1/en
17. https://pubmed.ncbi.nlm.nih.gov/26609882/
18. https://meshb.nlm.nih.gov/record/ui?ui=D058830

Last updated: 2025-03-24