NITRIC OXIDE | A203144 | AIRGAS THERAPEUTICS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Mallinckrodt Pharmaceuticals Ireland Limited et al v. Airgas Therapeutics LLC et al 14 patentsANDA 203144Nitric Oxide Gas for Inhalation | D. Del. | 2022-12-30 | Terminated 2023-06-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Ikaria, Inc. (Kleinfeld, Kaplan, and Becker, LLP) - Citizen Petition FDA-2013-P-0070 · 10 docket documents Ikaria, Inc., through counsel Kleinfeld, Kaplan, and Becker, LLP, filed a citizen petition regarding inhaled nitric oxide, an investigational drug being developed by Ohmeda Inc. under IND 44,124 for treatment of persistent pulmonary hypertension in neonates and acute respiratory distress syndrome. T | Other | 2013-02-04 | Denied | — |
Ikaria, Inc., (Kleinfeld, Kaplan, and Becker, LLP) - Citizen Petition FDA-2012-P-1103 · 7 docket documents Ikaria, Inc., filed this citizen petition requesting that the FDA revoke or condition the orphan drug designation granted to GeNO, LLC in June 2012 for nitric oxide to treat persistent pulmonary hypertension in newborns, the same indication for which Ikaria's subsidiary holds NDA 20-845 for INOmax ( | 505(q) | 2012-11-05 | Denied | — |
12TH Man Technologies - Citizen Petition FDA-2011-P-0727 · 4 docket documents 12th Man Technologies filed a citizen petition on October 4, 2011, requesting that the FDA review and revoke the pediatric exclusivity grant awarded to INO Therapeutics for INOMax (Nitric Oxide Gas) under NDA No. 20-845, contending that the grant does not satisfy the statutory requirements of FD&C A | Other | 2011-10-11 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.