Details for New Drug Application (NDA): 215272
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NDA 215272 describes VTAMA, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the VTAMA profile page.
The generic ingredient in VTAMA is tapinarof. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tapinarof profile page.
The generic ingredient in VTAMA is tapinarof. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tapinarof profile page.
Summary for 215272
| Tradename: | VTAMA |
| Applicant: | Organon Llc |
| Ingredient: | tapinarof |
| Patents: | 12 |
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 | Organon LLC | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Dec 12, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ATOPIC DERMATITIS IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 23, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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