NITRIC OXIDE | N202860 | VERO BIOTECH INC
| 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.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7560076 | Apr 21, 2027 | — | — | Yes | — | — |
| 7618594 | Oct 17, 2026 | — | — | Yes | — | — |
| 7947227 | Oct 17, 2026 | — | — | — | — | |
| 8057742 | Jan 18, 2026 | — | — | — | — | |
| 8607785 | Jul 14, 2030 | — | — | Yes | — | — |
| 8944049 | Aug 13, 2029 | — | — | Yes | — | — |
| 9604028 | Aug 13, 2029 | — | — | — | — | |
| 9701538 | Jan 28, 2029 | — | — | Yes | — | — |
| 10213572 | Feb 12, 2036 | — | — | Yes | — | — |
| 10737051 | Oct 20, 2035 | — | — | Yes | — | — |
| 10926054 | Aug 13, 2029 | — | — | Yes | — | — |
| 11103669 | Jun 21, 2030 | — | — | Yes | — | — |
| 11511252 | Sep 21, 2029 | — | — | Yes | — | — |
| 11672938 | Jul 22, 2040 | — | — | — | — |