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Generated: November 21, 2018

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Details for New Drug Application (NDA): 204569

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NDA 204569 describes BELSOMRA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the BELSOMRA profile page.

The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this compound. Additional details are available on the suvorexant profile page.
Summary for 204569
Tradename:BELSOMRA
Applicant:Merck Sharp Dohme
Ingredient:suvorexant
Patents:1
Generic Entry Opportunity Date for 204569
Generic Entry Date for 204569*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 204569
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BELSOMRA suvorexant TABLET;ORAL 204569 NDA Merck Sharp & Dohme Corp. 0006-0005 0006-0005-13 1 BLISTER PACK in 1 CASE (0006-0005-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK
BELSOMRA suvorexant TABLET;ORAL 204569 NDA Merck Sharp & Dohme Corp. 0006-0005 0006-0005-30 3 CASE in 1 CARTON (0006-0005-30) > 1 BLISTER PACK in 1 CASE (0006-0005-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 13, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 13, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Nov 20, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF INSOMNIA

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 13, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 13, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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