Serotonin-1b and Serotonin-1d Receptor Agonist Drug Class List

Drugs in Drug Class: Serotonin-1b and Serotonin-1d Receptor Agonist

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajanta Pharma Ltd	ALMOTRIPTAN MALATE	almotriptan malate	TABLET;ORAL	205523-001	Mar 3, 2016	AB	RX	No	No
Ajanta Pharma Ltd	ALMOTRIPTAN MALATE	almotriptan malate	TABLET;ORAL	205523-002	Mar 3, 2016	AB	RX	No	Yes
Mylan	ALMOTRIPTAN MALATE	almotriptan malate	TABLET;ORAL	205171-001	Nov 9, 2015	AB	RX	No	No

Serotonin-1b and Serotonin-1d Receptor Agonist Market Analysis and Financial Projection

The market for Serotonin-1B (5-HT1B) and Serotonin-1D (5-HT1D) receptor agonists is driven by their critical role in treating migraines and neurological disorders, with significant growth projected in both therapeutic demand and intellectual property development. Below is a detailed analysis of market dynamics and the patent landscape:

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Market Dynamics

Market Size and Growth

• The global triptan market (a key subclass of 5-HT1B/1D agonists) was valued at $4.5 billion in 2022, projected to reach $6.78 billion by 2030 at a 5.3% CAGR[18].
• The broader serotonin receptor-targeting drug market (including antagonists) reached $3.5 billion in 2023, growing to $5.2 billion by 2031 (5% CAGR)[1].

Key Drivers

1. Rising Migraine Prevalence: Migraines affect 40 million Americans, with triptans like sumatriptan being first-line treatments for acute attacks[5][11][15].
2. Formulation Innovation: Intranasal delivery systems (e.g., Tonix’s Tosymra®) improve bioavailability and onset of action, capturing market share[3][5][11].
3. Generics vs. Branded Drugs: Generic penetration is rising, but patents for novel formulations (e.g., Tosymra®’s intranasal delivery system expiring in 2030) sustain revenue for innovators[3][7][11].
4. Combination Therapies: Partnerships to develop 5-HT1B/1D agonists with COX-2 inhibitors or other adjuvants aim to enhance efficacy[15].

Competitive Landscape

• Dominant Players: Pfizer (Nurtec®), Novartis, Teva, and GlaxoSmithKline lead the market, while newer entrants like Tonix Pharmaceuticals focus on differentiated delivery systems[13][18].
• Generic Competition: Sumatriptan generics hold 45% of the SSRI market volume in some regions, pressuring pricing[7].

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Patent Landscape

Key Patents and Innovations

Patent/Innovation	Description	Expiration	Significance
US 12,090,139 (Tonix)	Covers intranasal sumatriptan formulations for migraines	2030	Strengthens Tosymra®’s IP protection against generics[3][5][11].
EP 1126841B1	Combines 5-HT1B/1D agonists (e.g., rizatriptan) with COX-2 inhibitors	Expired	Highlights trend toward combination therapies[15].
WO2019233994 (Exscientia)	AI-designed DSP-1181 (5-HT1A agonist) showcases tech disrupting drug discovery[2].	Pending	Signals AI’s growing role in receptor-targeted drug development.
US 9211282B2	Sumatriptan nasal spray compositions	Expired	Basis for later innovations like Tosymra®[14].

Emerging Trends

1. Delivery Systems: 67% of recent patents focus on novel formulations (e.g., intranasal, fast-dissolving) to improve patient compliance[3][14].
2. AI-Driven Drug Design: Companies like Exscientia use AI to optimize receptor binding, reducing trial phases[2].
3. Dual-Target Agonists: Drugs like DSP-0038 (5-HT1A agonist/5-HT2A antagonist) hint at expanded applications in Alzheimer’s psychosis[2][16].

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Challenges and Opportunities

• Regulatory Hurdles: Safety concerns around vasoconstriction limit use in cardiovascular patients[9].
• Generic Pressure: Sumatriptan’s US patent expired in 2006, but formulation patents extend commercial viability[6][11].
• Untapped Markets: Asia-Pacific and Latin America offer growth due to rising healthcare access[1][18].

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"The new patent for Tosymra® exemplifies how formulation innovation can offset generic competition, securing market exclusivity until 2030"[11].

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Key Takeaways

• The 5-HT1B/1D agonist market is migration-driven, with triptans dominating acute migraine care.
• IP strategies prioritize delivery optimization and combination therapies to extend revenue cycles.
• AI and dual-target agonists represent the next frontier in serotonin receptor drug development.

For stakeholders, differentiation via IP and patient-centric formulations will be critical as generics proliferate.

References

1. https://www.marketresearchintellect.com/product/global-serotonin-antagonists-market-size-and-forecast/
2. https://www.cas.org/resources/cas-insights/ai-drug-discovery-assessing-the-first-ai-designed-drug-candidates-to-go-into-human-clinical-trials
3. https://www.globenewswire.com/news-release/2024/09/19/2948856/28908/en/Tonix-Pharmaceuticals-Announces-Issuance-of-U-S-Patent-by-the-United-States-Patent-and-Trademark-Office-Covering-the-Intranasal-Delivery-of-FDA-Approved-Tosymra-to-Treat-Migraines.html
4. https://patents.google.com/patent/AU2021356114A9/en
5. https://www.biospace.com/press-releases/tonix-pharmaceuticals-announces-issuance-of-u-s-patent-by-the-united-states-patent-and-trademark-office-covering-the-intranasal-delivery-of-fda-approved-tosymra-to-treat-migraines
6. https://en.wikipedia.org/wiki/Sertraline
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC5870275/
8. https://patents.google.com/patent/US11021435B2/zh
9. https://journals.sagepub.com/doi/full/10.1046/j.1468-2982.2003.00583.x
10. https://www.cognitivemarketresearch.com/triptan-market-report
11. https://www.stocktitan.net/news/TNXP/tonix-pharmaceuticals-announces-issuance-of-u-s-patent-by-the-united-0t5dd324ilht.html
12. https://patents.google.com/patent/US7659285B2/en
13. https://reports.valuates.com/market-reports/QYRE-Auto-12K8543/global-and-united-states-triptan
14. https://patents.google.com/patent/US9211282B2/en
15. https://patents.google.com/patent/EP1126841B1/en
16. https://synapse.patsnap.com/drug/aab142418b9f46489a3a7054203888df
17. https://investors.amneal.com/news/press-releases/press-release-details/2017/Impax-Announces-Favorable-Ruling-Regarding-Patent-Validity-for-Zomig-zolmitriptan-Nasal-Spray/default.aspx
18. https://github.com/rajvarma2516/Market-Research-Analysis/blob/main/4/Triptans-for-Migraine-Headaches-Market-Size-and-Opportunity-Analysis.md