Details for New Drug Application (NDA): 214958
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NDA 214958 describes SOTYKTU, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SOTYKTU profile page.
The generic ingredient in SOTYKTU is deucravacitinib. One supplier is listed for this compound. Additional details are available on the deucravacitinib profile page.
The generic ingredient in SOTYKTU is deucravacitinib. One supplier is listed for this compound. Additional details are available on the deucravacitinib profile page.
Summary for 214958
| Tradename: | SOTYKTU |
| Applicant: | Bristol |
| Ingredient: | deucravacitinib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214958
Generic Entry Date for 214958*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 214958
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOTYKTU | deucravacitinib | TABLET;ORAL | 214958 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0895 | 0003-0895-11 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) |
| SOTYKTU | deucravacitinib | TABLET;ORAL | 214958 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0895 | 0003-0895-91 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Sep 9, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 9, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 7, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 7, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY | ||||||||
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