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.
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 |


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
Sponsor | Phase |
---|---|
Merck Sharp & Dohme LLC | Phase 2 |
University of Maryland, Baltimore | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for BELSOMRA
US Patents and Regulatory Information for BELSOMRA
BELSOMRA is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BELSOMRA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted diazepan orexin receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
FDA Regulatory Exclusivity protecting BELSOMRA
INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY P061, A RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-SITE, DOUBLE-BLIND STUDY TO EVALUATE SAFETY AND EFFICACY OF SUVOREXANT FOR THE TREATMENT OF INSOMNIA IN SUBJECTS WITH ALZHEIMERS DISEASE
Exclusivity Expiration: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
Patent: 8881
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07328267
Estimated Expiration: ⤷ Try a Trial
Patent: 10249269
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0719361
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 70892
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07003441
Estimated Expiration: ⤷ Try a Trial
Patent: 10001173
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1627028
Estimated Expiration: ⤷ Try a Trial
Patent: 1880276
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 90524
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 859
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0130002
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 13798
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 89382
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 009000126
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 099374
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 09003276
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 89382
Estimated Expiration: ⤷ Try a Trial
Patent: 92572
Estimated Expiration: ⤷ Try a Trial
Honduras
Patent: 09001067
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 28691
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 75427
Estimated Expiration: ⤷ Try a Trial
Patent: 35758
Estimated Expiration: ⤷ Try a Trial
Patent: 67803
Estimated Expiration: ⤷ Try a Trial
Patent: 10511621
Estimated Expiration: ⤷ Try a Trial
Patent: 11068665
Estimated Expiration: ⤷ Try a Trial
Patent: 11079848
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 1834
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09005712
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 016
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7334
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 0900100
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 2586
Estimated Expiration: ⤷ Try a Trial
Patent: 092470
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 081229
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 89382
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 89382
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 58924
Estimated Expiration: ⤷ Try a Trial
Patent: 61727
Estimated Expiration: ⤷ Try a Trial
Patent: 09125024
Estimated Expiration: ⤷ Try a Trial
Patent: 10150818
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 617
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 89382
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0903334
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1217057
Estimated Expiration: ⤷ Try a Trial
Patent: 1299426
Estimated Expiration: ⤷ Try a Trial
Patent: 090087110
Estimated Expiration: ⤷ Try a Trial
Patent: 100031767
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 97188
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 13696
Estimated Expiration: ⤷ Try a Trial
Patent: 15188
Estimated Expiration: ⤷ Try a Trial
Patent: 0831494
Estimated Expiration: ⤷ Try a Trial
Patent: 1109318
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 0974
Estimated Expiration: ⤷ Try a Trial
Patent: 6873
Estimated Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | |
Ecuador | SP099374 | ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO | ⤷ Try a Trial |
Russian Federation | 2759837 | СОСТАВЫ ТВЕРДЫХ ДОЗИРОВАННЫХ ЛЕКАРСТВЕННЫХ ФОРМ АНТАГОНИСТА ОРЕКСИНОВОГО РЕЦЕПТОРА (COMPOSITIONS OF SOLID DOSAGE FORMS OF OREXIN RECEPTOR ANTAGONIST) | ⤷ Try a Trial |
Mexico | 368859 | FORMULACIONES DE DOSIS SOLIDA DE UN ANTAGONISTA DEL RECEPTOR DE OREXINA. (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST.) | ⤷ Try a Trial |
Spain | 2397188 | ⤷ Try a Trial | |
Russian Federation | 2561727 | СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ (COMPOUNDS OF SUBSTITUTED DIAZEPANES AS ANTAGONISTS OF OREXIN RECEPTORS) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |