Details for New Drug Application (NDA): 219155
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NDA 219155 describes ANZUPGO, which is a drug marketed by Leo Pharma As and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ANZUPGO profile page.
The generic ingredient in ANZUPGO is delgocitinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the delgocitinib profile page.
The generic ingredient in ANZUPGO is delgocitinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the delgocitinib profile page.
Summary for 219155
| Tradename: | ANZUPGO |
| Applicant: | Leo Pharma As |
| Ingredient: | delgocitinib |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219155
Generic Entry Date for 219155*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CREAM;TOPICAL |
*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: 219155
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 219155
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANZUPGO | delgocitinib | CREAM;TOPICAL | 219155 | NDA | LEO Pharma, Inc | 50222-280 | 50222-280-30 | 1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE |
| ANZUPGO | delgocitinib | CREAM;TOPICAL | 219155 | NDA | LEO Pharma, Inc | 50222-280 | 50222-280-91 | 1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2% | ||||
| Approval Date: | Jul 23, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 23, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF INHIBITING JANUS KINASE 2 OR JANUS KINASE 3 TO TREAT MODERATE TO SEVERE CHRONIC HAND ECZEMA (CHE) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO, OR FOR WHOM TOPICAL CORTICOSTEROIDS ARE NOT ADVISABLE | ||||||||
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