TREPROSTINIL | N021272 | UNITED THERAPEUTICS CORP
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2020-00769 | 9593066 | IPR | Liquidia Technologies, Inc. | Institution Denied | 2020-03-30 | — |
| IPR2020-00770 | 9604901Delisted | IPR | Liquidia Technolgies, Inc. | Final Written Decision | 2020-03-30 | 2024-08-20 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2013-01-16 | Terminated 2014-08-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lassman Law + Policy FDA-2021-P-0714 · 5 docket documents Scott M. Lassman filed this citizen petition on behalf of a client requesting that the FDA refuse to approve the New Drug Application for Tyvaso DPI (treprostinil dry powder inhalation), a formulation containing FDKP excipient intended for patients with pulmonary arterial hypertension and pulmonary | Other | 2021-07-13 | Denied | Lassman Law + Policy |
Citizen Petition from Hyman, Phelps & McNamara, PC on behalf of United Therap... FDA-2018-P-0598 · 14 docket documents Hyman, Phelps & McNamara, P.C. on behalf of United Therapeutics Corporation filed this citizen petition under sections 501 and 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any ANDA for a treprostinil inhalation solution referencing Tyvaso unless the | 505(q) | 2018-02-07 | Denied | United Therapeutics Corporation |
United Therapeutics Corp - Citizen Petition FDA-2013-P-1293 · 3 docket documents United Therapeutics Corp. filed this citizen petition pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any abbreviated new drug application for treprostinil that omits critical safety information regarding the administration of intrav | 505(q) | 2013-11-13 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.