You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

~ Buy the BELSOMRA (suvorexant) Drug Profile, 2024 PDF Report in the Report Store ~

BELSOMRA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try a Trial

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

See all BELSOMRA clinical trials

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 ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-004 Aug 13, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-004 Aug 13, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-001 Aug 13, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-003 Aug 13, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  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
Japan 5767803 ⤷  Try a Trial
Taiwan 201109318 Substituted diazepan orexin receptor antagonists ⤷  Try a Trial
Australia 2007328267 Substituted diazepan compounds as orexin receptor antagonists ⤷  Try a Trial
Taiwan I513696 ⤷  Try a Trial
Ecuador SP099374 ANTAGONISTAS DE RECEPTOR DE OREXINA DE DIAZEPAN SUSTITUIDO ⤷  Try a Trial
European Patent Office 2854816 FORMULATIONS PHARMACEUTIQUES SOLIDES D'UN ANTAGONISTE DE RÉCEPTEUR D'OREXINE (SOLID DOSAGE FORMULATIONS OF AN OREXIN RECEPTOR ANTAGONIST) ⤷  Try a Trial
China 109078015 食欲素受体拮抗剂的固体剂量制剂 (Solid dosage formulations of an orexin receptor antagonist) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.