Details for New Drug Application (NDA): 216665
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NDA 216665 describes VYKAT XR, which is a drug marketed by Soleno Therap and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the VYKAT XR profile page.
The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diazoxide choline profile page.
The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diazoxide choline profile page.
Summary for 216665
| Tradename: | VYKAT XR |
| Applicant: | Soleno Therap |
| Ingredient: | diazoxide choline |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216665
Generic Entry Date for 216665*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
TABLET, EXTENDED RELEASE;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: 216665
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYKAT XR | diazoxide choline | TABLET, EXTENDED RELEASE;ORAL | 216665 | NDA | Soleno Therapeutics, Inc. | 83860-025 | 83860-025-01 | 30 TABLET, FILM COATED in 1 BOTTLE (83860-025-01) |
| VYKAT XR | diazoxide choline | TABLET, EXTENDED RELEASE;ORAL | 216665 | NDA | Soleno Therapeutics, Inc. | 83860-075 | 83860-075-01 | 30 TABLET, FILM COATED in 1 BOTTLE (83860-075-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 26, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 26, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 12,178,823 | Patent Expiration: | Nov 12, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS | ||||||||
| Patent: | 12,343,348 | Patent Expiration: | Nov 12, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING HYPERPHAGIA AND REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS | ||||||||
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