TREPROSTINIL | N022387 | UNITED THERAPEUTICS CORP
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2016-00006 | 8497393Delisted | IPR | SteadyMed Ltd. et al. | Final Written Decision | 2015-10-02 | — |
| IPR2017-01622 | 9339507 | IPR | Watson Laboratories, Inc. | Terminated-Settled | 2017-06-21 | — |
| IPR2017-01621 | 9358240 | IPR | Watson Laboratories, Inc. | Terminated-Settled | 2017-06-21 | — |
| 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. Del. | 2023-09-05 | Active | — | |
| D. Del. | 2020-06-04 | Terminated 2022-09-09 | — | |
UNITED THERAPEUTICS CORPORATION v. WATSON LABORATORIES, INC. 5 patentsANDA 208172treprostinil | D.N.J. | 2015-07-22 | Terminated 2018-09-18 | — |
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 Petiton from Hyman, Phelps & McNamara, PC on behalf of United Therape... FDA-2018-P-2659 · 14 docket documents On behalf of United Therapeutics Corporation, this petition filed by Hyman, Phelps & McNamara, P.C. on July 10, 2018, requests that the FDA Commissioner refrain from approving any abbreviated new drug application (ANDA) for a generic treprostinil inhalation solution referencing the brand-name Tyvaso | 505(q) | 2018-07-11 | Withdrawn | — |
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 |
Citizen Petition from Hyman, Phelps & McNamara, P.C. (United Therapeutics Corp) FDA-2017-P-2162 · 14 docket documents United Therapeutics Corporation filed this citizen petition under sections 501 and 505 of the FDCA requesting that the FDA refrain from approving any ANDA for generic treprostinil inhalation solution unless the proposed product includes a specific delivery device with the same critical design attrib | 505(q) | 2017-04-07 | Denied | Hyman, Phelps & McNamara, P.C. (United Therapeutics Corp) |
Citizen Petition from Hogan Lovells US LLP (United Therapeutics Corporation (UT) FDA-2016-P-2478 · 14 docket documents United Therapeutics Corporation, through counsel Hogan Lovells US LLP, filed this citizen petition on August 10, 2016, requesting that the FDA refrain from approving any Abbreviated New Drug Application (ANDA) for generic treprostinil inhalation solution referencing Tyvaso unless the proposed generi | 505(q) | 2016-08-11 | Denied | Hogan Lovells US LLP (United Therapeutics Corporation (UT) |
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.