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. Additional details are available on the ADQUEY profile page.
The generic ingredient in ADQUEY is difamilast. One supplier is listed for this compound. Additional details are available on the difamilast profile page.
The generic ingredient in ADQUEY is difamilast. 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: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219474
Generic Entry Date for 219474*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
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 | 3 g in 1 TUBE (72893-017-07) |
| ADQUEY | difamilast | OINTMENT;TOPICAL | 219474 | NDA | Acrotech Biopharma Inc | 72893-017 | 72893-017-08 | 27 g in 1 TUBE (72893-017-08) |
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 | ||||||||
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