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Last Updated: July 19, 2024

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BELSOMRA Drug Patent Profile


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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 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

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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: 198
Drug Prices: Drug price information for BELSOMRA
What excipients (inactive ingredients) are in BELSOMRA?BELSOMRA excipients list
DailyMed Link:BELSOMRA at DailyMed
Drug patent expirations by year for BELSOMRA
Drug Prices for BELSOMRA

See drug prices for BELSOMRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BELSOMRA
Generic Entry Date for BELSOMRA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Merck Sharp & Dohme LLCPhase 2
University of Maryland, BaltimorePhase 2
Columbia UniversityPhase 4

See all BELSOMRA clinical trials

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 two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BELSOMRA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Solid dosage formulations of an orexin receptor antagonist
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted diazepan orexin receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-004 Aug 13, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-004 Aug 13, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 3979
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAM SUSTITUIDOS
Estimated Expiration: ⤷  Sign Up

Patent: 8881
Patent: 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
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 07328267
Patent: Substituted diazepan compounds as orexin receptor antagonists
Estimated Expiration: ⤷  Sign Up

Patent: 10249269
Patent: Substituted diazepan compounds as orexin receptor antagonists
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0719361
Patent: COMPOSTO OU UM SAL FARMACEUTICAMENTE ACEITÁVEL DO MESMO, COMPOSIÇÃO FARMACÊUTICA, USO DE UM COMPOSTO OU DE UM SAL FARMACEUTICAMENTE ACEITÁVEL DO MESMO, MÉTODOS PARA MELHORAR A QUALIDADE DO SONO EM UM PACIENTE MAMÍFERO, PARA TRATAR INSÔNIA EM UM PACIENTE MAMÍFERO E PARA TRATAR OU CONTROLAR OBESIDADE EM UM PACIENTE MAMÍFERO
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 70892
Patent: ANTAGONISTES DES RECEPTEURS DE L'OREXINE SOUS FORME DE COMPOSES DE DIAZEPANE SUBSTITUES (SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 07003441
Patent: COMPUESTOS DERIVADOS DE 1,4-DIAZEPAM SUSTITUIDO, ANTAGONISTAS DEL RECEPTOR DE OREXINA; COMPOSICION FARMACEUTICA; Y USO PARA EL TRATAMIENTO O PREVENCION DE UN TRASTORNO DEL SUENO, PARA POTENCIAR LA CALIDAD DEL SUENO, Y PARA TRATAR O CONTROLAR LA OBESI
Estimated Expiration: ⤷  Sign Up

Patent: 10001173
Patent: 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)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1627028
Patent: Substituted diazepan compounds as orexin receptor antagonists
Estimated Expiration: ⤷  Sign Up

Patent: 1880276
Patent: Substituted diazepan compounds as orexin receptor antagonists
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 90524
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAM SUSTITUIDO
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 859
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAM SUSTITUIDO
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0130002
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 13798
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 89382
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 009000126
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUÍDO
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 099374
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO
Estimated Expiration: ⤷  Sign Up

El Salvador

Patent: 09003276
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 89382
Patent: ANTAGONISTES DES RÉCEPTEURS DE L'OREXINE SOUS FORME DE COMPOSÉS DE DIAZÉPANE SUBSTITUÉS (SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS)
Estimated Expiration: ⤷  Sign Up

Patent: 92572
Patent: Antagonistes des récepteurs de l'orexine sous forme de composés de diazépane substitués (Substituted diazepan compounds as orexin receptor antagonists)
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 09001067
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 28691
Patent: SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 75427
Estimated Expiration: ⤷  Sign Up

Patent: 35758
Estimated Expiration: ⤷  Sign Up

Patent: 67803
Estimated Expiration: ⤷  Sign Up

Patent: 10511621
Estimated Expiration: ⤷  Sign Up

Patent: 11068665
Patent: SUBSTITUTED DIAZEPAN COMPOUND AS OREXIN RECEPTOR ANTAGONIST
Estimated Expiration: ⤷  Sign Up

Patent: 11079848
Patent: SUBSTITUTED DIAZEPANE COMPOUND AS OREXIN RECEPTOR ANTAGONIST
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 1834
Patent: SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09005712
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAM SUSTITUIDO. (SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 016
Patent: COMPOSES DE DIAZEPAN SUBSTITUES COMME ANTAGONISTES DES RECEPTEURS DE L'OREXINE.
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 7334
Patent: SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 0900100
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 2586
Estimated Expiration: ⤷  Sign Up

Patent: 092470
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 081229
Patent: ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAM SUSTITUIDO
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 89382
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 89382
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 58924
Patent: СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ (DIAZEPANE SUBSTITUTED COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS)
Estimated Expiration: ⤷  Sign Up

Patent: 61727
Patent: СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ (COMPOUNDS OF SUBSTITUTED DIAZEPANES AS ANTAGONISTS OF OREXIN RECEPTORS)
Estimated Expiration: ⤷  Sign Up

Patent: 09125024
Patent: СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ
Estimated Expiration: ⤷  Sign Up

Patent: 10150818
Patent: СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 617
Patent: SUPSTITUISANA JEDINJENJA DIAZEPANA KAO ANTAGONISTI RECEPTORA ZA OREKSIN (SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 89382
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0903334
Patent: Substituted diazepan compounds as orexin receptor antagonists
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1217057
Estimated Expiration: ⤷  Sign Up

Patent: 1299426
Estimated Expiration: ⤷  Sign Up

Patent: 090087110
Patent: SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
Estimated Expiration: ⤷  Sign Up

Patent: 100031767
Patent: SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 97188
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 13696
Estimated Expiration: ⤷  Sign Up

Patent: 15188
Estimated Expiration: ⤷  Sign Up

Patent: 0831494
Patent: Substituted diazepan orexin receptor antagonists
Estimated Expiration: ⤷  Sign Up

Patent: 1109318
Patent: Substituted diazepan orexin receptor antagonists
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 0974
Patent: СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ КАК АНТАГОНИСТЫ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ;СПОЛУКИ ЗАМІЩЕНИХ ДІАЗЕПАНІВ ЯК АНТАГОНІСТИ ОРЕКСИНОВИХ РЕЦЕПТОРІВ (SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS)
Estimated Expiration: ⤷  Sign Up

Patent: 6873
Patent: СПОЛУКИ ЗАМІЩЕНИХ ДІАЗЕПАНІВ ЯК АНТАГОНІСТИ ОРЕКСИНОВИХ РЕЦЕПТОРІВ
Estimated Expiration: ⤷  Sign Up

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
Brazil 112014025041 composição farmacêutica ⤷  Sign Up
Ecuador SP099374 ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO ⤷  Sign Up
Croatia P20130002 ⤷  Sign Up
Japan 2011068665 SUBSTITUTED DIAZEPAN COMPOUND AS OREXIN RECEPTOR ANTAGONIST ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.