ROFLUMILAST | N022522 | ASTRAZENECA PHARMACEUTICALS LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTRAZENECA PHARMACEUTICALS LP et al v. AUROBINDO PHARMA LIMITED et al 3 patentsANDA 213298Roflumilast | D.N.J. | 2019-05-15 | Terminated 2020-02-07 | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. ALKEM LABORATORIES LTD. 3 patentsANDA 212490Roflumilast | D.N.J. | 2018-11-21 | Terminated 2019-11-12 | — |
| D.N.J. | 2016-04-13 | Terminated 2017-09-29 | — | |
| D.N.J. | 2015-05-15 | Terminated 2017-06-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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
$14.98
per ea
Lowest NADAC/Unit
$14.81
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00310008828DALIRESP 250 MCG TABLET | $14.98 | EA | Brand | $1.91 | 2026-01-01 |
| 00310008839DALIRESP 250 MCG TABLET | $14.98 | EA | Brand | $1.91 | 2026-01-01 |
| 00310009530DALIRESP 500 MCG TABLET | $14.81 | EA | Brand | $0.3204 | 2026-06-17 |
| 00310009590DALIRESP 500 MCG TABLET | $14.81 | EA | Brand | $0.3204 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.