Suvorexant - Generic Drug Details

What are the generic sources for suvorexant and what is the scope of patent protection?

Suvorexant is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Suvorexant has seventy-five patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for suvorexant

International Patents:	75
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	61
Patent Applications:	464
What excipients (inactive ingredients) are in suvorexant?	suvorexant excipients list
DailyMed Link:	suvorexant at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for suvorexant

Constraining patent/regulatory exclusivity:

7,951,797

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for suvorexant

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medical University of South Carolina	Phase 4
University of Maryland, Baltimore	Phase 2
Johns Hopkins University	Early Phase 1

See all suvorexant clinical trials

Pharmacology for suvorexant

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Cytochrome P450 3A Inhibitors Orexin Receptor Antagonists P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for suvorexant

N05CJ	Orexin receptor antagonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for SUVOREXANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELSOMRA	Tablets	suvorexant	5 mg, 10 mg, 15 mg and 20 mg	204569	1	2024-03-04

US Patents and Regulatory Information for suvorexant

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	204569-002	Aug 13, 2014		RX	Yes	No	10,098,892		Y
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	204569-001	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	204569-004	Aug 13, 2014		RX	Yes	Yes	7,951,797		Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	7,951,797		Y	Y

International Patents for suvorexant

Country	Patent Number	Title	Estimated Expiration
Japan	5335758
Nicaragua	200900100	ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO
Canada	2795550
Japan	2015518867
Norway	342586
Russian Federation	2014152031

Suvorexant Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Suvorexant

Introduction to Suvorexant

Suvorexant, marketed under the brand name BELSOMRA, is an orexin receptor antagonist approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Here, we delve into the market dynamics and financial trajectory of suvorexant, a key player in the insomnia treatment market.

Market Segmentation and Growth Drivers

Dosage and Application

Suvorexant is available in various dosages, including 5mg, 10mg, 15mg, and 20mg, with the optimal dose often being 20mg daily[1].

• The drug is primarily used for treating insomnia but has potential applications in other sleep disorders and conditions such as depression and anxiety.

Clinical Research and Technological Developments

Advanced clinical research has been a significant driver for the growth of the orexin receptor antagonists market, including suvorexant. Studies have shown that suvorexant has a good safety and tolerance profile, especially in patients with obstructive sleep apnea (OSA)[1].

• Technological developments in the pharmaceutical sector have also boosted the market, enabling the production of advanced drugs with reduced adverse drug reactions (ADRs)[1].

Increasing Cases of Insomnia

The rising prevalence of insomnia is a major factor driving the demand for suvorexant. The global insomnia market is expected to grow from USD 5.0 billion in 2022 to USD 7.0 billion by 2032, with a CAGR of 3.5% during the forecast period[4].

Cost-Effectiveness and Comparative Analysis

Cost-Effectiveness Against Zolpidem

A cost-effectiveness analysis in Japan showed that suvorexant is more cost-effective than zolpidem, a widely used hypnotic benzodiazepine receptor agonist. Suvorexant had lower costs and higher quality-adjusted life years (QALYs) compared to zolpidem, making it a viable alternative for elderly patients with insomnia[2].

Risk of Hip Fractures

However, studies have also highlighted that suvorexant may be associated with a higher risk of hip fractures compared to benzodiazepine receptor agonists (BZRAs). This risk needs to be carefully evaluated, especially in elderly patients[5].

Market Size and Forecast

Global Orexin Receptor Antagonists Market

The global orexin receptor antagonists market, which includes suvorexant, is expected to witness significant growth during the forecast period from 2022 to 2029. The market is segmented by dosage, drugs, application, route of administration, end-users, and distribution channels[1].

Regional Analysis

North America dominates the global orexin receptor antagonists market, driven by extensive research and development activities and a high number of FDA approvals. Asia-Pacific is also expected to show lucrative growth due to developing healthcare facilities and government initiatives[1].

Distribution Channels and End-Users

Distribution Channels

Hospital pharmacies hold the largest revenue share in the distribution of suvorexant and other insomnia treatments. This is due to the need for medical supervision and accurate dosage administration, which hospital pharmacies can ensure[4].

End-Users

The primary end-users of suvorexant include hospitals, homecare settings, and specialty centers. The drug's availability and prescription requirements contribute to its dominance in these segments[1].

Financial Trajectory

Revenue and Market Share

The drug segment, particularly orexin antagonists like suvorexant, dominates the global insomnia market. The increasing use of these drugs due to their reduced ADRs and effectiveness is expected to fuel market growth. Suvorexant's cost-effectiveness and its approval for additional indications, such as insomnia in patients with mild to moderate Alzheimer's disease, further support its financial trajectory[3][4].

Competitive Landscape

Suvorexant competes with other orexin receptor antagonists like lemborexant and daridorexant. However, its early market entry and extensive clinical data have given it a strong market position. The ongoing research and development activities by key players, including Merck, are expected to maintain and enhance suvorexant's market share[1][3].

Regulatory Framework and Challenges

Regulatory Approvals

Suvorexant has received approvals from regulatory bodies such as the FDA, including a label update to include findings from a study on insomnia in patients with mild to moderate Alzheimer's disease. These approvals are crucial for its market growth and acceptance[3].

Risks and Uncertainties

The pharmaceutical industry faces various risks, including general industry conditions, competition, economic factors, and regulatory changes. These factors can impact the financial trajectory of suvorexant and the broader orexin receptor antagonists market[3].

Key Takeaways

• Market Growth: The global orexin receptor antagonists market, driven by suvorexant, is expected to grow significantly from 2022 to 2029.
• Cost-Effectiveness: Suvorexant is more cost-effective than traditional hypnotics like zolpidem, especially in elderly patients.
• Distribution: Hospital pharmacies dominate the distribution channels due to the need for medical supervision.
• Regulatory Approvals: Suvorexant has received key regulatory approvals, including for use in patients with Alzheimer's disease.
• Competitive Landscape: Suvorexant competes with other orexin receptor antagonists but maintains a strong market position due to early market entry and extensive clinical data.

FAQs

What is suvorexant used for?

Suvorexant is used for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

How does suvorexant compare to zolpidem in terms of cost-effectiveness?

Suvorexant is more cost-effective than zolpidem, with lower costs and higher QALYs, making it a viable alternative for elderly patients with insomnia[2].

What are the potential risks associated with suvorexant?

Suvorexant may be associated with a higher risk of hip fractures compared to BZRAs, which needs careful evaluation, especially in elderly patients[5].

Which distribution channel dominates the market for suvorexant?

Hospital pharmacies hold the largest revenue share in the distribution of suvorexant due to the need for medical supervision and accurate dosage administration[4].

What is the forecasted growth of the global orexin receptor antagonists market?

The global orexin receptor antagonists market is expected to witness significant growth from 2022 to 2029, driven by advanced clinical research and technological developments[1].

Sources

1. Data Bridge Market Research: Global Orexin Receptor Antagonists Market Insight & Industry Growth.
2. PubMed: Cost-effectiveness analysis of suvorexant for the treatment of insomnia.
3. Merck: Merck Receives Approval for BELSOMRA® (suvorexant) C-IV Label Update.
4. MarketResearch.biz: Insomnia Market Size, Share, Growth, Trends and Forecast 2032.
5. PLOS ONE: Effectiveness of suvorexant versus benzodiazepine receptor agonist.