ROFLUMILAST | N215985 | ARCUTIS BIOTHERAPEUTICS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Arcutis Biotherapeutics, Inc. v. Padagis Israel Pharmaceuticals Ltd. et al 6 patentsANDA 219158roflumilast | D. Del. | 2024-03-27 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Arcutis Biotherapeutics, Inc. FDA-2023-P-5364 · 37 docket documents 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 | Open | Arcutis Biotherapeutics, Inc. |
Physicians for Integrity in Medical Research, Inc. - Citizen Petition FDA-2011-P-0768 · 8 docket documents Physicians for Integrity in Medical Research, Inc. filed this citizen petition under 21 CFR 10.30 on October 16, 2011, requesting that the FDA revoke its approval of roflumilast (Deliresp) for severe chronic obstructive pulmonary disease, which was approved on February 28, 2011. The petitioner conte | Other | 2011-11-02 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$15.41
per gm
Lowest NADAC/Unit
$15.38
per gm
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 80610010560ZORYVE 0.05% CREAM | $15.41 | GM | Brand | — | 2026-06-17 |
| 80610011560ZORYVE 0.15% CREAM | $15.40 | GM | Brand | — | 2026-06-17 |
| 80610013060ZORYVE 0.3% CREAM | $15.38 | GM | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| 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 |