ROFLUMILAST | N215985 | ARCUTIS BIOTHERAPEUTICS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Arcutis Biotherapeutics, Inc. FDA-2023-P-5364 Arcutis Biotherapeutics, Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act on December 4, 2023, requesting that the FDA refuse to approve any abbreviated new drug application using ZORYVE (roflumilast) topical cream 0.3% as the reference listed drug unles | 505(q) | 2023-12-06 | Denied | Arcutis Biotherapeutics |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9884050 | Jun 7, 2037 | — | — | Yes | — | — |
| 9907788 | Jun 7, 2037 | — | — | — | — | |
| 10940142 | Jun 7, 2037 | — | — | Yes | — | — |
| 11129818 | Aug 25, 2037 | — | — | — | — | |
| 11793796 | Jun 7, 2037 | — | — | Yes | — | — |
| 11819496 | Jun 7, 2037 | — | — | — | — | |
| 11992480 | Jun 7, 2037 | — | — | — | — | |
| 12005051 | Jun 7, 2037 | — | — | — | — | |
| 12005052 | Jun 7, 2037 | — | — | Yes | — | — |
| 12011437 | Jun 7, 2037 | — | — | Yes | — | — |
| 12016848 | Jun 7, 2037 | — | — | Yes | — | — |
| 12042487 | Jun 7, 2037 | — | — | Yes | — | — |
| 12220409 | Jun 7, 2037 | — | — | Yes | — | — |
| 12257242 | Jun 7, 2037 | — | — | Yes | — | — |
| 12310956 | Jun 7, 2037 | — | — | — | — | |
| 12336983 | Jun 7, 2037 | — | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| NPP | Oct 5, 2026 | < 1 year |