BELSOMRA Drug Patent Profile

When do Belsomra patents expire, and when can generic versions of Belsomra launch?

Belsomra is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this compound. Additional details are available on the suvorexant profile page.

DrugPatentWatch^® Generic Entry Outlook for Belsomra

Belsomra was eligible for patent challenges on August 13, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 20, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BELSOMRA

International Patents:	75
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	33
Patent Applications:	336
Drug Prices:	Drug price information for BELSOMRA
What excipients (inactive ingredients) are in BELSOMRA?	BELSOMRA excipients list
DailyMed Link:	BELSOMRA at DailyMed

See drug prices for BELSOMRA

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

NDA:

204569

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 BELSOMRA

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 2
Merck Sharp & Dohme LLC	Phase 2
Merck Sharp & Dohme LLC	Phase 4

See all BELSOMRA clinical trials

Pharmacology for BELSOMRA

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

Paragraph IV (Patent) Challenges for BELSOMRA

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 BELSOMRA

BELSOMRA is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes			Y

International Patents for BELSOMRA

When does loss-of-exclusivity occur for BELSOMRA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

European Patent Office

Honduras

Hong Kong

Japan

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BELSOMRA around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	106873	СПОЛУКИ ЗАМІЩЕНИХ ДІАЗЕПАНІВ ЯК АНТАГОНІСТИ ОРЕКСИНОВИХ РЕЦЕПТОРІВ
Canada	2795550	FORMES PHARMACEUTIQUES POSOLOGIQUES SOLIDES D'UN ANTAGONISTE DES RECEPTEURS DES OREXINES (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST)
Ukraine	100974	СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ КАК АНТАГОНИСТЫ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ;СПОЛУКИ ЗАМІЩЕНИХ ДІАЗЕПАНІВ ЯК АНТАГОНІСТИ ОРЕКСИНОВИХ РЕЦЕПТОРІВ (SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS)
Argentina	088881	UNA COMPOSICION FARMACEUTICA QUE COMPRENDE 5-CLORO-2-{(5R)-5-METIL-4-[5-METIL-2-(2H-1,2,3-TRIAZOL-2-IL)BENZOIL]-1,4-DIAZEPAN-1-IL}-1,3-BENZOXAZOL; O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y SU USO EN LA PREPARACION DE MEDICAMENTOS

Market Dynamics and Financial Trajectory for BELSOMRA

Introduction

BELSOMRA (suvorexant), developed by Merck, is a groundbreaking insomnia treatment that has been making significant waves in the pharmaceutical industry since its approval in 2015. This article delves into the market dynamics and financial trajectory of BELSOMRA, highlighting its impact, growth prospects, and the challenges it faces.

Mechanism of Action and Market Position

BELSOMRA is the first and only orexin receptor antagonist approved for the treatment of insomnia in adults who have difficulty falling asleep and/or staying asleep. By selectively blocking orexin receptors, it suppresses the wake drive in the brain, offering a new mechanism of action distinct from traditional hypnotics like benzodiazepines and Z-drugs[3].

Market Outlook and Growth Prospects

The insomnia treatment market, where BELSOMRA operates, is anticipated to grow at a compound annual growth rate (CAGR) of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032 across the seven major markets. This growth is largely driven by the increasing patient share of dual orexin receptor antagonists (DORAs), a category that includes BELSOMRA, Eisai’s Dayvigo (lemborexant), and Idorsia’s Quviviq (daridorexant)[1].

Sales Performance

Since its launch, BELSOMRA has shown promising sales performance. By February 2015, it had already surpassed 1,000 weekly prescriptions in the US, and its potential market was estimated at around 2 billion doses per year when including Japan[4].

Financial Impact on Merck

The financial performance of BELSOMRA is closely tied to Merck's overall pharmaceutical sales. In the third quarter of 2024, Merck reported total worldwide sales of $16.7 billion, with pharmaceutical sales increasing by 5% driven by growth in various therapeutic areas, although the specific contribution of BELSOMRA was not detailed in this report[2].

Revenue Contribution

While the exact revenue generated by BELSOMRA is not separately disclosed in Merck's recent financial reports, it is part of the broader insomnia treatment market that is expected to contribute significantly to Merck's revenue. The launch of BELSOMRA and other DORAs has been instrumental in capturing patient share from traditional hypnotics, thereby driving revenue growth[1].

Market Challenges

Despite the positive outlook, the insomnia treatment market, including BELSOMRA, faces several challenges.

Patent Exclusivity and Generic Competition

The loss of patent exclusivity for BELSOMRA in the US in 2029 and in Japan in 2031 will allow cheaper generic versions to enter the market, potentially eroding sales for the branded product. Similarly, Dayvigo is set to lose market exclusivity in the US in 2031, which could impact the overall market dynamics[1].

Pricing and Regulatory Barriers

Drug pricing and market exclusivity are significant obstacles. The high cost of innovative treatments like DORAs can limit their adoption, especially in markets with strict price controls. Additionally, regulatory hurdles can slow the penetration of new therapies, affecting their market growth[1].

Competitive Landscape

BELSOMRA operates in a competitive landscape that includes other DORAs and traditional insomnia treatments.

Other DORAs

Eisai’s Dayvigo (lemborexant) and Idorsia’s Quviviq (daridorexant) are key competitors in the DORA segment. These drugs, like BELSOMRA, offer a new mechanism of action and are gaining traction in the market[1].

Traditional Treatments

Traditional hypnotics such as Z-drugs, benzodiazepines, and low-dose sedating antidepressants still hold a significant market share. However, DORAs are increasingly capturing patient share from these older pharmacological treatments[1].

Pipeline and Future Prospects

The future growth of the insomnia treatment market, including BELSOMRA, will be influenced by pipeline products.

Late-Stage Pipeline Products

Products like Vanda Pharmaceuticals’ Hetlioz (tasimelteon), EUSOL’s SM-1 (diphenhydramine + lorazepam + zolpidem), Taisho Pharmaceutical’s vornorexant, and Imbrium Therapeutics’s sunobinop are expected to contribute $330.2 million in sales by 2032. These launches will further diversify the treatment options available and potentially drive market growth[1].

Regional Market Dynamics

The US is the largest market for insomnia treatments, accounting for 81.9% of sales in the seven major markets by 2032. The dominance of the US market is due to its larger insomnia population and higher drug prices. New launches, including Hetlioz, SM-1, and sunobinop, are forecast to occur primarily in the US market[1].

Key Takeaways

• Market Growth: The insomnia treatment market is expected to grow at a CAGR of 2.6% from 2022 to 2032, driven by DORAs like BELSOMRA.
• Competitive Landscape: BELSOMRA competes with other DORAs and traditional insomnia treatments, but its unique mechanism of action sets it apart.
• Financial Impact: BELSOMRA contributes to Merck's pharmaceutical sales, though specific figures are not detailed.
• Challenges: Loss of patent exclusivity, generic competition, and pricing barriers are significant challenges.
• Future Prospects: Pipeline products and increased uptake of DORAs will drive future market growth.

FAQs

What is the mechanism of action of BELSOMRA?

BELSOMRA works by selectively blocking orexin receptors, which suppresses the wake drive in the brain, helping patients fall asleep and stay asleep[3].

How is the market for insomnia treatments expected to grow?

The market is anticipated to grow at a CAGR of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032, driven by the increasing use of DORAs[1].

What are the main challenges facing BELSOMRA in the market?

The main challenges include the loss of patent exclusivity, generic competition, and pricing barriers[1].

Which regions are expected to drive the growth of the insomnia treatment market?

The US is expected to be the largest market, accounting for 81.9% of sales in the seven major markets by 2032[1].

What pipeline products are expected to contribute to the market growth?

Products like Hetlioz, SM-1, vornorexant, and sunobinop are expected to contribute $330.2 million in sales by 2032[1].

Sources

1. European Pharmaceutical Review: Market outlook to 2032: future trends across the seven major markets.
2. Business Wire: Merck Announces Third-Quarter 2024 Financial Results.
3. Merck: Merck's Insomnia Medicine BELSOMRA® (suvorexant) C-IV, the First and Only Orexin Receptor Antagonist, Now Available in the United States.
4. Practical Neurology: Belsomra: A First Look.

Last updated: 2024-12-16