Mechanism of Action: Serotonin 1b Receptor Agonists

Drugs with Mechanism of Action: Serotonin 1b Receptor Agonists

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
Chartwell Rx	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	205186-002	Aug 29, 2017	AB	RX	No	No
Mylan	ALMOTRIPTAN MALATE	almotriptan malate	TABLET;ORAL	205171-001	Nov 9, 2015	AB	RX	No	No
Mylan	ALMOTRIPTAN MALATE	almotriptan malate	TABLET;ORAL	205171-002	Nov 9, 2015	AB	RX	No	No
Teva Pharms Usa	ALMOTRIPTAN MALATE	almotriptan malate	TABLET;ORAL	078027-001	Jul 7, 2015	AB	RX	No	No
Teva Pharms Usa	ALMOTRIPTAN MALATE	almotriptan malate	TABLET;ORAL	078027-002	Jul 7, 2015	AB	RX	No	No

Serotonin 1b Receptor Agonists Market Analysis and Financial Projection

The market for Serotonin 1B (5-HT1B) receptor agonists is experiencing dynamic growth, driven by expanding therapeutic applications and innovation in drug development. These compounds target conditions ranging from migraines to neurodegenerative diseases, with a competitive patent landscape reflecting both established players and emerging entrants.

Market Dynamics

1. Growth Projections:
   The global 5-hydroxytryptamine receptor agonist market is projected to grow at a 9.8% CAGR[14], fueled by rising demand for treatments addressing migraines, depression, Alzheimer’s disease (AD)[8], and pulmonary arterial hypertension (PAH)[16]. The market size is expected to reach billions of dollars by 2032[14].

2. Key Therapeutic Areas:

   • Migraine Management: Triptans (e.g., sumatriptan) dominate acute migraine therapy[2], but newer agents like lasmiditan (a 5-HT1F agonist) are advancing through Phase III trials[2][12].
   • Neurodegeneration: Preclinical studies highlight 5-HT1B agonists’ potential to reduce amyloid-beta-induced neuroinflammation in AD[8].
   • Obesity and Metabolic Disorders: Emerging combinations with GLP-1 agonists and amylin analogs aim to enhance efficacy[6].

3. Competitive Landscape:
   Major players include Heron Therapeutics, Kyowa Kirin, and Sun Pharmaceutical, with innovation focused on oral small molecules (e.g., Lilly’s orforglipron) to rival injectable peptides[6][14]. Pipeline drugs are in Phase I–III trials, targeting diverse indications[12].

4. Drivers and Challenges:

   • Drivers: Personalized medicine trends, novel formulations (e.g., sublingual/oral), and repurposing for anti-inflammatory effects[8][14].
   • Challenges: Safety concerns (e.g., cardiac risks with early agonists like sumatriptan[4]) and the need for subtype-specific ligands to minimize side effects[15].

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Patent Landscape

1. Key Patents and Expirations:

   • Sumatriptan Derivatives: Patents like US11021435B2 (expiring 2025)[1] and EP1126841B1 (expired) cover migraine-specific combinations with COX-2 inhibitors[11].
   • Novel Formulations: Oral and sublingual delivery methods for lasmiditan are protected under trials COL MIG-102/103[2].
   • Overlap in GLP-1 Agonists: Novo Nordisk’s semaglutide patents (expiring 2025–2031[7]) highlight strategies to extend exclusivity through formulation tweaks.

2. Innovation Trends:

   • Combination Therapies: Example: 5-HT1B/1D agonists paired with COX-2 inhibitors to enhance efficacy[11].
   • Herbal Compounds: EG, a natural 5-HT1B agonist from herbal sources, shows promise for AD but faces patenting hurdles[8].

3. Geographic and Legal Factors:

   • Patent expirations in the U.S. (e.g., liraglutide in 2023[7]) are accelerating generic competition, while new filings in Asia-Pacific aim to capture growing demand[14].

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Future Outlook

• Emerging Applications: PAH treatment via 5-HT1B antagonists (e.g., Imperial College’s optimized molecules[16]) and anti-inflammatory effects in AD[8].
• Market Expansion: Oral small molecules and polypill combinations (e.g., GLP-1/amylin/GIP blends[6]) could disrupt injectable-dominated markets.
• Regulatory and Safety Hurdles: Rigorous testing for CNS and cardiovascular side effects remains critical, as seen in lasmiditan’s Phase III trials[2].

The 5-HT1B agonist sector balances innovation with biosimilar pressures, positioning it for sustained growth amid evolving therapeutic needs.

References

1. https://patents.google.com/patent/US11021435B2/zh
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC5848843/
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC10210334/
4. https://www.reprocell.com/blog/biopta/5ht1b-receptor
5. https://pubs.acs.org/doi/10.1021/cn400155t
6. https://www.stifel.com/newsletters/investmentbanking/bal/marketing/healthcare/biopharma_timopler/stifelobesityupdate_july2024.pdf
7. https://www.keionline.org/wp-content/uploads/KEI-BN-2024-1.pdf
8. https://pmc.ncbi.nlm.nih.gov/articles/PMC8450432/
9. https://www.businesswire.com/news/home/20210517005514/en/Global-Chemotherapy-induced-Nausea-and-Vomiting-Drugs-Market-Report-2021-Serotonin-Receptor-Antagonist-is-Projected-to-Account-for-$1.2-Billion-of-the-Total-$3.2-Billion-Market-by-2027---ResearchAndMarkets.com
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC5919989/
11. https://patents.google.com/patent/EP1126841B1/en
12. https://www.researchandmarkets.com/reports/4382682/5-ht1b-agonists-pipeline-insight-2024
13. https://synapse.patsnap.com/drug/aab142418b9f46489a3a7054203888df
14. https://github.com/guzasbahsas/Market-Research-Report-List-1/blob/main/5-hydroxytryptamine-receptor-agonist-market.md
15. https://pubmed.ncbi.nlm.nih.gov/12052194/
16. https://spiral.imperial.ac.uk/bitstreams/89ec1125-73ed-4007-b0d1-9f8609ed7ee6/download