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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim

Last Updated: January 17, 2021

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BELSOMRA Drug 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-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.

US ANDA Litigation and 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
Drug patent expirations by year for BELSOMRA
Drug Prices for BELSOMRA

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Generic Entry Opportunity Date for BELSOMRA
Generic Entry Date for BELSOMRA*:
Constraining patent/regulatory exclusivity:

*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

Washington University School of MedicinePhase 2
Henry Ford Health SystemPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2

See all BELSOMRA clinical trials

US Patents and Regulatory Information for BELSOMRA

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   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-003 Aug 13, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-004 Aug 13, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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.