Details for New Drug Application (NDA): 215272
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NDA 215272 describes VTAMA, which is a drug marketed by Dermavant Sci and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the VTAMA profile page.
The generic ingredient in VTAMA is tapinarof. One supplier is listed for this compound. Additional details are available on the tapinarof profile page.
The generic ingredient in VTAMA is tapinarof. One supplier is listed for this compound. Additional details are available on the tapinarof profile page.
Summary for 215272
| Tradename: | VTAMA |
| Applicant: | Dermavant Sci |
| Ingredient: | tapinarof |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215272
Generic Entry Date for 215272*:
Constraining patent/regulatory exclusivity:
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: 215272
| Mechanism of Action | Aryl Hydrocarbon Receptor Agonists |
Suppliers and Packaging for NDA: 215272
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VTAMA | tapinarof | CREAM;TOPICAL | 215272 | NDA | Dermavant Sciences, Inc. | 81672-5051 | 81672-5051-1 | 1 TUBE in 1 PACKAGE (81672-5051-1) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | May 23, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 19, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS | ||||||||
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