Details for New Drug Application (NDA): 204569
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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: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for NDA: 204569
Mechanism of Action | Cytochrome P450 3A Inhibitors Orexin Receptor Antagonists P-Glycoprotein Inhibitors |
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 LLC | 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 LLC | 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: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 13, 2014 | TE: | RLD: | Yes | |||||
Patent: | 10,098,892 | Patent Expiration: | May 29, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 11,980,623 | Patent Expiration: | May 29, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 7,951,797 | Patent Expiration: | Nov 20, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF INSOMNIA |
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