PHENYLEPHRINE HYDROCHLORIDE | N203510 | PARAGON BIOTECK INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| PGR2015-00011 | 8859623 | PGR | Altaire Pharmaceuticals, Inc. | Final Written Decision | 2015-05-11 | — |
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from VPCI, Inc. FDA-2018-P-1008 · 5 docket documents VPCI, Inc. filed a suitability petition under Section 505(j)(2)(C) of the Food, Drug and Cosmetic Act requesting permission to submit an Abbreviated New Drug Application for phenylephrine hydrochloride injection at a concentration of 0.1 mg/mL, which differs from the Reference Listed Drug VAZCULEP ( | Suitability | 2018-03-07 | Withdrawn | VPCI, Inc. |
Citizen Petition from the University of Florida FDA-2015-P-4131 · 6 docket documents The University of Florida filed this citizen petition under 21 CFR Part 10.30 requesting that the FDA issue a final rule removing oral phenylephrine (both phenylephrine hydrochloride and phenylephrine bitartrate) from the Final Monograph for OTC nasal decongestant drug products, arguing that subsequ | Other | 2015-11-13 | Partially Denied | the University of Florida |
Citizen Petition from REGCON Solutions LLC (Akorn Inc) FDA-2015-P-1449 · 4 docket documents REGCON Solutions LLC filed this citizen petition on behalf of Akorn Inc. requesting that the FDA amend the Orange Book to designate Akorn's Phenylephrine hydrochloride ophthalmic solution/drops 2.5% and 10% (NDA 207926) as a second reference-listed drug under Section 505(j), arguing that without thi | 505(q) | 2015-05-08 | Granted | REGCON Solutions LLC (Akorn Inc) |
Citizen Petition from Strides Inc. FDA-2006-P-0395 · 7 docket documents Strides Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Drug Application for Ibuprofen Potassium 200 mg Phenylephrine Hydrochloride 10 mg Capsules, which substitutes phenylephrine hydrochloride | Other | 2008-11-24 | Withdrawn | Strides Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.30
per ml
Lowest NADAC/Unit
$5.30
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 42702010305PHENYLEPHRINE 10% EYE DROP | $5.30 | ML | Generic | — | 2026-06-17 |
| 82260010305PHENYLEPHRINE 10% EYE DROP | $5.30 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8859623 | Nov 14, 2033 | — | — | — | — |