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 are four patents protecting this drug. Additional details are available on the BELSOMRA profile page.
The generic ingredient in BELSOMRA is suvorexant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the suvorexant profile page.
The generic ingredient in BELSOMRA is suvorexant. There is one drug master file entry for this compound. 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: | 4 |
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: | ⤷ Start Trial | Patent Expiration: | May 29, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 29, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 29, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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