HALOBETASOL PROPIONATE; TAZAROTENE | N209354 | BAUSCH HEALTH AMERICAS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BAUSCH HEALTH IRELAND LIMITED et al v. TARO PHARMACEUTICALS INC. et al 4 patentsANDA 217190halobetasol propionate 0.01%; tazarotene 0.045% | D.N.J. | 2022-07-21 | Terminated 2024-04-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Baker Hostetler on behalf of Bausch Health Companies, Inc. FDA-2021-P-0550 · 45 docket documents Baker Hostetler, on behalf of Bausch Health Companies, Inc., filed this citizen petition on May 28, 2021, requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act referencing Duobrii as the r | 505(q) | 2021-06-16 | Denied | Bausch Health Companies, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8809307 | Nov 2, 2031 | — | — | Yes | — | — |
| 10251895 | Jun 6, 2036 | — | — | Yes | — | — |
| 10426787 | Jun 6, 2036 | — | — | — | — | |
| 10478502 | Nov 2, 2031 | — | — | Yes | — | |
| 11648256 | Jun 6, 2036 | — | — | Yes | — | |
| 11679115 | Jun 6, 2036 | — | — | Yes | — | |
| 11839656 | Nov 2, 2031 | — | — | — | — | |
| 11957753 | Nov 2, 2031 | — | — | Yes | — | — |
| 11986527 | Nov 2, 2031 | — | — | — | — | |
| 12076403 | Nov 2, 2031 | — | — | Yes | — | — |