ARIPIPRAZOLE | N021436 | OTSUKA PHARMACEUTICAL CO LTD
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2017-00287 | 9125939 | IPR | Alkermes Pharma Ireland Limited et al. | Institution Denied | 2016-11-17 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2014-12-24 | Terminated 2017-09-29 | — | |
| D.N.J. | 2014-07-11 | Terminated 2018-03-05 | — | |
OTSUKA PHARMACEUTICAL CO., LTD. v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 3 patentsANDA 78614aripiprazole | D.N.J. | 2014-07-07 | Terminated 2016-03-10 | — |
OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG et al 2 patentsANDA 20607aripiprazole | D.N.J. | 2014-03-28 | Terminated 2014-11-03 | — |
OTSUKA PHARMACEUTICAL CO., LTD. v. ZYDUS PHARMACEUTICALS USA, INC. et al 1 patentANDA 090472aripiprazole | D.N.J. | 2010-06-04 | Terminated 2010-11-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Otsuka Pharmaceutical Development and Commercialization... FDA-2015-P-2482 Otsuka Pharmaceutical Development & Commercialization, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refuse to approve or delay approval of Alkermes plc's NDA for aripiprazole lauroxil on two grounds: that approval should be wit | 505(q) | 2015-07-14 | Denied | Otsuka Pharmaceutical Development and Commercialization |
Citizen Petition from Otsuka Pharmaceutical Company Ltd., (Otsuka Pharmaceuti... FDA-2014-P-1354 Otsuka Pharmaceutical Development & Commercialization, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refuse to accept for substantive review an NDA submitted by Alkermes plc for aripiprazole lauroxil, arguing that the applicatio | 505(q) | 2014-09-11 | Denied | Otsuka Pharmaceutical Company Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.