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Last Updated: May 30, 2020

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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-four 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:
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
Henry Ford Health SystemPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2

See all BELSOMRA clinical trials

Synonyms for BELSOMRA
((7R)-4-(5-Chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone
(R)-(4-(5-chlorobenzo[d]oxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2H-1,2,3-triazol
(R)-(4-(5-Chlorobenzo[d]oxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone
[(7R)-4-(5-Chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone
081L192FO9
1030377-33-3
2737AH
5-Chloro-2-[(5R)-5-methyl-4-[5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoyl]-1,4-diazepan-1-yl]-1,3-benzoxazole
5-Chloro-2-[(5R)-5-methyl-4-[5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoyl]-1,4-diazepan-1-yl]-1,3-benzoxazole MK 4305
A11500
AB0072958
AC-30276
ACN-029994
AK110529
AKOS022185167
AS-74879
BCP0726000197
BDBM50318701
Belsomra (TN)
C23H23ClN6O2
CAS:1030377-33-3;MK-4305
CHEBI:82698
CHEMBL1083659
CS-0614
D10082
DB09034
DORA-analogue
DTXSID90145616
EX-A211
FT-0697203
GTPL2890
HY-10807
J-690010
JYTNQNCOQXFQPK-MRXNPFEDSA-N
KS-0000062S
Methanone, ((7R)-4-(5-chloro-2-benzoxazolyl)hexahydro-7-methyl-1H-1,4-diazepin-1-yl)(5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl)-
Methanone, [(7R)-4-(5-chloro-2-benzoxazolyl)hexahydro-7-Methyl-1H-1,4-diazepin-1-yl][5-Methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]-
MK 4305
MK-4305
MK4305
Q7650517
QCR-177
SB16485
SC-94530
SCHEMBL1586289
ST2401560
SUV
Suvorexant
Suvorexant (JAN/USAN)
Suvorexant (MK-4305)
Suvorexant [USAN:INN]
Suvorexant; MK 4305
SW219649-1
UNII-081L192FO9
W-5905
ZINC49036447

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 Y   Start Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-003 Aug 13, 2014 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No   Start Trial   Start Trial Y Y   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:

Colorcon
AstraZeneca
Merck
Johnson and Johnson
Boehringer Ingelheim
McKesson

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.