Orexin Receptor Antagonist Drug Class List

Drugs in Drug Class: Orexin Receptor Antagonist

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	7,951,797		Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	11,980,623		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	11,980,623		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No	7,951,797		Y	Y

Orexin Receptor Antagonist Market Analysis and Financial Projection

The Orexin Receptor Antagonists (ORAs) market is experiencing dynamic growth driven by increasing global prevalence of sleep disorders and expanding therapeutic applications. This analysis synthesizes market trends, patent activity, and competitive strategies shaping this pharmaceutical sector.

Market Size and Growth Projections

• 2022 Baseline: Valued between $1.8B[1] and $4.5B[8], reflecting regional and segment variations.
• 2030 Forecast: Projected to reach $4.9B[1]–$6.9B[8], with CAGRs ranging from 6.2%[8] to 13.3%[1].
• Key Drivers:
  • Sleep Disorders: 30% of adults experience insomnia[6], with 50% global prevalence expected by 2025[12].
  • Mental Health Expansion: Potential use in depression/anxiety management[1][14].
  • Aging Populations: 30–50% of U.S. seniors have insomnia[3], mirroring trends in China (15%) and India (72%)[3].

Regional Market Dynamics

Region	Market Position	Key Factors
North America	Market Leader (40%)	High healthcare spending, FDA-approved drugs like Belsomra[3][8]
Asia-Pacific	Fastest Growth	Stress-related insomnia + 72% prevalence in Indian seniors[3]
Europe	Innovation Hub	TheraCryf’s Ox-1 antagonist patent (2024)[13]

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Patent Landscape and Key Players

Major Patents and Expirations

Patent	Assignees	Expiry	Impact
US7951797B2[5][16]	Merck (Belsomra)	2029	Protects suvorexant API until generic entry[15]
WO-2018206956-A1[2]	BenevolentAI	–	Novel compounds for neuropsychiatric disorders
EP Grant[13]	TheraCryf (Ox-1 antagonist)	2040s	“Strongest IP” for anxiety/addiction treatment

Pipeline Developments:

• Phase III: Takeda’s dual orexin agonist for narcolepsy (twice-daily dosing)[14].
• Preclinical: NLS Pharmaceutics’ AEX-2 reduces cataplexy by 70% in models[10].
• Strategic Edge: Alkermes’ once-daily orexin 2 agonist[14] vs. competitors’ dosing.

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Competitive Strategies

1. R&D Diversification: Companies like NLS target neurodegenerative/metabolic disorders via multi-target therapies (e.g., Sigma-1 receptor modulation)[10].
2. Formulation Innovation: Merck’s controlled-release tablets (US10098892)[5] extend market exclusivity to 2033.
3. Geographic Expansion: Sun Pharma and Teva accelerating generics for Asia-Pacific[8].

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Regulatory and Market Challenges

• Safety Scrutiny: Residual sedation risks require pharmacovigilance[12][14].
• Patent Cliffs: Belsomra faces generic competition post-2029[5][15], potentially reducing prices by 30–80%.
• Cultural Barriers: Preference for traditional therapies in Asia complicates uptake[12].

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Key Takeaways

• The ORA market will exceed $6B by 2030, fueled by sleep disorder prevalence and off-label mental health use.
• Merck and Takeda dominate through patent-protected brands, while generics loom post-2029.
• Next-generation agonists (e.g., AEX-2) could disrupt treatment paradigms for narcolepsy and neurodegeneration.

“Non-sulfonamide dual orexin agonists like AEX-2 represent a paradigm shift in managing sleep and metabolic disorders.” – NLS Pharmaceutics[10]

FAQs

1. When will Belsomra generics launch?
   Likely post-2029, pending patent challenges[15].
2. Which regions offer the highest growth?
   Asia-Pacific, due to aging populations and rising stress[3][8].
3. Are OREXIN drugs safe long-term?
   Current data shows tolerability, but residual sedation monitoring is critical[12][14].
4. What’s the next major indication for ORAs?
   Neurodegeneration (e.g., Parkinson’s) via Sigma-1 receptor targeting[10][14].
5. How do ORAs compare to traditional sedatives?
   Lower dependency risk but require rigorous dosing compliance[12].

References

1. https://github.com/kritimehra287/market-research-professional-netwoek/blob/main/Orexin%20Receptor%20Antagonists%20Market%20Key%20Drivers%20and%20Forecast%202025-2032.md
2. https://pubchem.ncbi.nlm.nih.gov/patent/WO-2018206956-A1
3. https://www.coherentmarketinsights.com/market-insight/orexin-receptors-hypocretin-receptor-antagonist-market-2522
4. https://pubmed.ncbi.nlm.nih.gov/26593218/
5. https://pharsight.greyb.com/drug/belsomra-patent-expiration
6. https://www.verifiedmarketreports.com/product/orexin-receptor-antagonists-market/
7. https://www.drugpatentwatch.com/p/patent/7951797
8. https://reports.valuates.com/market-reports/QYRE-Auto-5T12436/global-orexin-receptor-antagonists
9. https://www.researchandmarkets.com/reports/4382751/orexin-receptor-hypocretin-receptor
10. https://sleepreviewmag.com/sleep-treatments/pharmaceuticals/emerging-compounds/potential-dual-orexin-receptor-agonist-therapy-closer-human-trials/
11. https://www.databridgemarketresearch.com/reports/global-orexin-receptor-antagonists-market
12. https://pmarketresearch.com/product/worldwide-silica-sol-coating-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/worldwide-orexin-receptor-antagonists-for-insomnia-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030
13. https://www.morningstar.co.uk/uk/news/AN_1732709764743468900/theracryf-gets-european-patent-for-drug-acquired-from-new-subsidiary-.aspx
14. https://www.pharmavoice.com/news/orexin-neuroscience-alkermes-takeda-narcolepsy/739607/
15. https://www.drugpatentwatch.com/p/tradename/BELSOMRA
16. https://patents.google.com/patent/US7951797B2/en