VTAMA — FDA application NDA215272
Listed sponsor: ORGANON LLC · OGN company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | VTAMA | TAPINAROF | CREAM | TOPICAL | 1% | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10426743 | 001 | listed patent expiry date: 2036-05-19 | U-4048 |
| Patent 10426743 | 001 | listed patent expiry date: 2036-05-19 | U-2625 |
| Patent 11458108 | 001 | listed patent expiry date: 2036-05-19 | drug product |
| Patent 11612573 | 001 | listed patent expiry date: 2036-05-19 | U-4048 |
| Patent 11612573 | 001 | listed patent expiry date: 2036-05-19 | U-2625 |
| Patent 11617724 | 001 | listed patent expiry date: 2036-05-19 | drug product |
| Patent 11622945 | 001 | listed patent expiry date: 2036-05-19 | drug product |
| Patent 10195160 | 001 | listed patent expiry date: 2036-05-23 | drug product |
| Patent 10647649 | 001 | listed patent expiry date: 2038-11-13 | drug substance |
| Patent 11597692 | 001 | listed patent expiry date: 2038-11-13 | drug substance, drug product |
| Patent 11497718 | 001 | listed patent expiry date: 2039-11-13 | U-4048 |
| Patent 11590088 | 001 | listed patent expiry date: 2039-11-13 | U-2625 |
| Patent 11938099 | 001 | listed patent expiry date: 2039-11-13 | U-4048 |
| Patent 12569453 | 001 | listed patent expiry date: 2039-12-18 | U-4048 |
| Exclusivity NCE | 001 | listed exclusivity date: 2027-05-23 | FDA code as listed |
| Exclusivity I-956 | 001 | listed exclusivity date: 2027-12-12 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- TAPINAROF · UNII 84HW7D0V04 · lmmol compound ZISJNXNHJRQYJO-CMDGGOBGSA-N · CHEMBL259571
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.