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 two patents protecting this drug.

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.

Indicators of Generic Entry

Summary for BELSOMRA

International Patents:	75
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	33
Patent Applications:	244
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
Merck Sharp & Dohme LLC	Phase 2
University of Maryland, Baltimore	Phase 2
Columbia University	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

Anatomical Therapeutic Chemical (ATC) Classes for BELSOMRA

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

US Patents and Regulatory Information for BELSOMRA

BELSOMRA is protected by two US patents and one FDA Regulatory Exclusivity.

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

Patents protecting BELSOMRA

FDA Regulatory Exclusivity protecting BELSOMRA

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
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No

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
Norway	342586
Ecuador	SP099374	ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO
Russian Federation	2759837	СОСТАВЫ ТВЕРДЫХ ДОЗИРОВАННЫХ ЛЕКАРСТВЕННЫХ ФОРМ АНТАГОНИСТА ОРЕКСИНОВОГО РЕЦЕПТОРА (COMPOSITIONS OF SOLID DOSAGE FORMS OF OREXIN RECEPTOR ANTAGONIST)
Mexico	368859	FORMULACIONES DE DOSIS SOLIDA DE UN ANTAGONISTA DEL RECEPTOR DE OREXINA. (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST.)
Spain	2397188
Russian Federation	2561727	СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ (COMPOUNDS OF SUBSTITUTED DIAZEPANES AS ANTAGONISTS OF OREXIN RECEPTORS)
Chile	2010001173	Compuestos derivados de 1,4-diazepam sustituido, antagonistas de ox1 y ox2; utiles para preparar un medicamento destinado al tratamiento o prevencion de un trastorno del sueño,para potenciar la calidad del sueno,y para tratar o controlar la obesidad.(divisional de la sol.n 3441-07)