Details for New Drug Application (NDA): 212905
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NDA 212905 describes YCANTH, which is a drug marketed by Verrica Pharms 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 YCANTH profile page.
The generic ingredient in YCANTH is cantharidin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cantharidin profile page.
The generic ingredient in YCANTH is cantharidin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cantharidin profile page.
Summary for 212905
| Tradename: | YCANTH |
| Applicant: | Verrica Pharms |
| Ingredient: | cantharidin |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212905
Generic Entry Date for 212905*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION;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: 212905
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YCANTH | cantharidin | SOLUTION;TOPICAL | 212905 | NDA | Verrica Pharmaceuticals Inc. | 71349-070 | 71349-070-01 | 1 APPLICATOR in 1 PACKAGE (71349-070-01) / 1 AMPULE in 1 APPLICATOR / .45 mL in 1 AMPULE |
| YCANTH | cantharidin | SOLUTION;TOPICAL | 212905 | NDA | Verrica Pharmaceuticals Inc. | 71349-070 | 71349-070-06 | 6 PACKAGE in 1 CARTON (71349-070-06) / 1 APPLICATOR in 1 PACKAGE (71349-070-01) / 1 AMPULE in 1 APPLICATOR / .45 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.7% | ||||
| Approval Date: | Jul 21, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 21, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 28, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL DELIVERY OF A CANTHARIDIN FORMULATION TO ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER FOR TREATING MOLLUSCUM CONTAGIOSUM | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 28, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF MOLLUSCUM CONTAGIOSUM IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
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