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BELSOMRA Drug Profile

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Which patents cover Belsomra, 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-two 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.

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

Summary for BELSOMRA

International Patents:	72
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	54
Clinical Trials:	23
Patent Applications:	33
Drug Prices:	Drug price information for BELSOMRA
DailyMed Link:	BELSOMRA at DailyMed

See drug prices for BELSOMRA

Generic Entry Opportunity Date for BELSOMRA

NDA:

204569

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
Beth Israel Deaconess Medical Center	Phase 4
US Department of Veterans Affairs	Phase 4
University of California, San Francisco	Phase 4

See all BELSOMRA clinical trials

Pharmacology for BELSOMRA

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Orexin Receptor Antagonists P-Glycoprotein Inhibitors Cytochrome P450 3A Inhibitors

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

AB0072958

AC-30276

ACN-029994

AJ-110996

AK110529

AKOS022185167

BC600366

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

KB-78902

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

MolPort-023-219-189

QCR-177

SB16485

SC-94530

SCHEMBL1586289

ST2401560

SUV

Suvorexant

Suvorexant (JAN/USAN)

Suvorexant (MK-4305)

Suvorexant [USAN:INN]

Suvorexant; MK 4305

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			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No

International Patents for BELSOMRA

Country	Patent Number	Estimated Expiration
Honduras	2009001067
Serbia	52617
Russian Federation	2458924
Taiwan	201109318
Taiwan	200831494
Russian Federation	2010150818
Russian Federation	2561727