Details for New Drug Application (NDA): 219474
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NDA 219474 describes ADQUEY, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ADQUEY profile page.
The generic ingredient in ADQUEY is difamilast. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the difamilast profile page.
The generic ingredient in ADQUEY is difamilast. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the difamilast profile page.
Summary for 219474
| Tradename: | ADQUEY |
| Applicant: | Acrotech Biopharma |
| Ingredient: | difamilast |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219474
Generic Entry Date for 219474*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;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: 219474
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 219474
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADQUEY | difamilast | OINTMENT;TOPICAL | 219474 | NDA | Acrotech Biopharma Inc | 72893-017 | 72893-017-07 | 1 TUBE in 1 CARTON (72893-017-07) / 3 g in 1 TUBE |
| ADQUEY | difamilast | OINTMENT;TOPICAL | 219474 | NDA | Acrotech Biopharma Inc | 72893-017 | 72893-017-08 | 1 TUBE in 1 CARTON (72893-017-08) / 27 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 1% | ||||
| Approval Date: | Feb 12, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 12, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,588,893 | Patent Expiration: | Dec 31, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | RE46792 | Patent Expiration: | Mar 1, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING ATOPIC DERMATITIS | ||||||||
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