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Last Updated: May 21, 2022

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-six patent family members in thirty-seven 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

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Summary for BELSOMRA
International Patents:76
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 27
Patent Applications: 272
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 Generic Entry Opportunity 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
The Scripps Research InstitutePhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Washington University School of MedicinePhase 2

See all BELSOMRA clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted diazepan orexin receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-003 Aug 13, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-004 Aug 13, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-003 Aug 13, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-001 Aug 13, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Patent: 8881
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07328267
Estimated Expiration: See Plans and Pricing

Patent: 10249269
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0719361
Estimated Expiration: See Plans and Pricing

Canada

Patent: 70892
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07003441
Estimated Expiration: See Plans and Pricing

Patent: 10001173
Estimated Expiration: See Plans and Pricing

China

Patent: 1627028
Estimated Expiration: See Plans and Pricing

Patent: 1880276
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 90524
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 859
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0130002
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13798
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 89382
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 009000126
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 099374
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 09003276
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 89382
Estimated Expiration: See Plans and Pricing

Patent: 92572
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 09001067
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 28691
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8825
Estimated Expiration: See Plans and Pricing

Japan

Patent: 75427
Estimated Expiration: See Plans and Pricing

Patent: 35758
Estimated Expiration: See Plans and Pricing

Patent: 67803
Estimated Expiration: See Plans and Pricing

Patent: 10511621
Estimated Expiration: See Plans and Pricing

Patent: 11068665
Estimated Expiration: See Plans and Pricing

Patent: 11079848
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1834
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09005712
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 016
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7334
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 0900100
Estimated Expiration: See Plans and Pricing

Norway

Patent: 2586
Estimated Expiration: See Plans and Pricing

Patent: 092470
Estimated Expiration: See Plans and Pricing

Peru

Patent: 081229
Estimated Expiration: See Plans and Pricing

Poland

Patent: 89382
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 89382
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 58924
Estimated Expiration: See Plans and Pricing

Patent: 61727
Estimated Expiration: See Plans and Pricing

Patent: 09125024
Estimated Expiration: See Plans and Pricing

Patent: 10150818
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 617
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 89382
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0903334
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1217057
Estimated Expiration: See Plans and Pricing

Patent: 1299426
Estimated Expiration: See Plans and Pricing

Patent: 090087110
Estimated Expiration: See Plans and Pricing

Patent: 100031767
Estimated Expiration: See Plans and Pricing

Spain

Patent: 97188
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 13696
Estimated Expiration: See Plans and Pricing

Patent: 15188
Estimated Expiration: See Plans and Pricing

Patent: 0831494
Estimated Expiration: See Plans and Pricing

Patent: 1109318
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 0974
Estimated Expiration: See Plans and Pricing

Patent: 6873
Estimated Expiration: See Plans and Pricing

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
Russian Federation 2458924 СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ (DIAZEPANE SUBSTITUTED COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS) See Plans and Pricing
Australia 2007328267 Substituted diazepan compounds as orexin receptor antagonists See Plans and Pricing
Hong Kong 1128691 SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS See Plans and Pricing
Nicaragua 200900100 ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO See Plans and Pricing
Ukraine 100974 СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ КАК АНТАГОНИСТЫ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ;СПОЛУКИ ЗАМІЩЕНИХ ДІАЗЕПАНІВ ЯК АНТАГОНІСТИ ОРЕКСИНОВИХ РЕЦЕПТОРІВ (SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS) See Plans and Pricing
South Korea 102123130 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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