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 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
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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: | 198 |
| Drug Prices: | Drug price information for BELSOMRA |
| What excipients (inactive ingredients) are in BELSOMRA? | BELSOMRA excipients list |
| DailyMed Link: | BELSOMRA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BELSOMRA
*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 |
| Columbia University | Phase 4 |
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.
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
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 | 204569-003 | Aug 13, 2014 | RX | Yes | No | ⤷ 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 | 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 | |||
| Merck Sharp Dohme | BELSOMRA | suvorexant | TABLET;ORAL | 204569-003 | Aug 13, 2014 | RX | Yes | No | ⤷ 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 |
|---|---|---|---|
| Peru | 20081229 | ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAM SUSTITUIDO | ⤷ Sign Up |
| Mexico | 368859 | FORMULACIONES DE DOSIS SOLIDA DE UN ANTAGONISTA DEL RECEPTOR DE OREXINA. (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST.) | ⤷ Sign Up |
| Denmark | 2089382 | ⤷ Sign Up | |
| Russian Federation | 2699358 | СОСТАВЫ ТВЕРДЫХ ДОЗИРОВАННЫХ ЛЕКАРСТВЕННЫХ ФОРМ АНТАГОНИСТА ОРЕКСИНОВОГО РЕЦЕПТОРА (COMPOSITIONS OF SOLID DOSAGE FORMS OF AN OREXIN RECEPTOR ANTAGONIST) | ⤷ Sign Up |
| Croatia | P20130002 | ⤷ 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.
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