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 four patents protecting this drug. Additional details are available on the SOTYKTU profile page.
The generic ingredient in SOTYKTU is deucravacitinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the deucravacitinib profile page.
The generic ingredient in SOTYKTU is deucravacitinib. There is one drug master file entry for this compound. 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: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214958
Generic Entry Date for 214958*:
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: 214958
| Mechanism of Action | Tyrosine Kinase 2 Inhibitors |
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 | ||||||||
| Regulatory Exclusivity Expiration: | Mar 6, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ACTIVE PSORIATIC ARTHRITIS IN ADULTS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 7, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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