LUBIPROSTONE | N021908 | SUCAMPO PHARMA AMERICAS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2020-01-28 | Terminated 2020-11-13 | — | |
SUCAMPO AG et al v. SUN PHARMACEUTICAL INDUSTRIES, LTD. et al 7 patentsANDA 212292lubiprostone | D.N.J. | 2018-10-30 | Terminated 2020-07-01 | — |
SUCAMPO AG et al v. TEVA PHARMACEUTICAL INDUSTRIES LTD. et al 9 patentsANDA 209920lubiprostone | D.N.J. | 2017-09-25 | Terminated 2018-09-19 | — |
SUCAMPO PHARMA, LLC et al v. AMNEAL PHARMACEUTICALS LLC 5 patentsANDA 209450lubiprostone | D.N.J. | 2017-04-13 | Terminated 2018-07-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Sucampo Pharma Americas, LLC FDA-2014-P-0144 Sucampo Pharma Americas, LLC filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA revise its draft bioequivalence criteria for lubiprostone capsules and apply the revised criteria to any abbreviated new drug application listing | 505(q) | 2014-01-31 | Denied | Sucampo Pharma Americas |
Source: Regulations.gov. FDA citizen petitions matched by application number.