FIDAXOMICIN | N201699 | CUBIST PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MERCK SHARP & DOHME LLC et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 4 patentsANDA 220102fidaxomicin | D.N.J. | 2025-02-24 | Terminated 2025-05-12 | — |
MERCK SHARP & DOHME CORP. et al v. ACTAVIS LABORATORIES FL, INC. 5 patentsANDA 208443fidaxomicin | D.N.J. | 2020-01-16 | Terminated 2020-02-13 | — |
MERCK SHARP & DOHME CORP. et al v. ACTAVIS LABORATORIES FL, INC. et al 5 patentsANDA 208443fidaxomicin | D.N.J. | 2015-08-31 | Terminated 2021-11-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Cubist Pharmaceuticals, Inc FDA-2015-P-1595 Cubist Pharmaceuticals, Inc. filed this citizen petition on May 6, 2015, requesting that the FDA impose scientifically appropriate bioequivalence standards for abbreviated new drug applications and 505(b)(2) new drug applications referencing DIFICID (fidaxomicin) 200 mg film-coated tablets as the re | 505(q) | 2015-10-27 | Denied | Cubist Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-367 | Jan 24, 2027 | < 1 year |