HYDROMORPHONE HYDROCHLORIDE | N019034 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2024-04-12 | Active | — | |
Fresenius Kabi USA, LLC et al v. Eurohealth International Sarl 2 patentsANDA 202159hydromorphone hydrochloride | D. Del. | 2018-06-01 | Terminated 2018-08-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Inc. FDA-2026-P-2718 Apotex Inc. submitted this citizen petition pursuant to 21 CFR 10.30 and 314.161 requesting that the FDA determine whether Dilaudid-HP (hydromorphone hydrochloride) 10 mg/mL, NDA 019034, held by Fresenius Kabi USA LLC has been voluntarily withdrawn from sale for reasons of safety or efficacy, as the | 505(q) | 2026-03-17 | Withdrawn | Apotex Inc. |
Suitability Citizen Petition from Abbott Laboratories FDA-1998-P-0840 Abbott Laboratories filed this suitability petition under Federal Food, Drug and Cosmetic Act Section 505(b)(2)(c) and 21 CFR 314.93(b) requesting FDA approval to submit an ANDA for Hydromorphone Hydrochloride Injection, USP at 0.2 mg/mL in 30 mL glass vials, a lower pre-diluted strength of the list | Suitability | 2024-06-05 | Denied | Abbott Laboratories |
Amendment for Suitability Citizen Petition from Abbott Laboratories FDA-1998-P-0840 Abbott Laboratories filed this December 1998 suitability petition, docket 98P-0821, requesting ANDA approval for Hydromorphone Hydrochloride Injection USP 0.2 mg/mL in 30 mL glass vials for intravenous and subcutaneous administration. The amendment revises proposed labeling to match the innovator pr | Suitability | 2024-06-05 | Denied | Abbott Laboratories |
Citizen Petition from Astra USA, Inc. FDA-1995-P-0146 Astra USA, Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act on January 24, 1995, requesting FDA acceptance of an Abbreviated New Drug Application for hydromorphone hydrochloride intravenous injection at 0.2 mg per mL in a 50 mL prefilled syringe for pati | Other | 2017-04-03 | Denied | Astra USA, Inc. |
Citizen Petition From Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) FDA-2014-P-0205 Purdue Pharma LP filed this citizen petition requesting that the FDA exercise its authority under Section 505(o) of the Federal Food, Drug and Cosmetic Act to impose safety labeling changes on immediate-release opioid analgesics parallel to those mandated for extended-release and long-acting opioid | Other | 2014-02-25 | Partially Denied | Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) |
Citizen Petition from The Weinberg Group, Inc. FDA-2004-P-0099 The Weinberg Group, Inc. filed this citizen petition pursuant to section 505(q)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Hydromorphone Hydrochloride tablets in 2 mg and 4 mg dosage strengths suitable for submission as an Abbreviated New Drug Application (ANDA | Other | 2008-08-05 | Granted | The Weinberg Group, Inc. |
Purdue Pharma L.P. FDA-2007-P-0003 Purdue Pharma L.P. filed this citizen petition regarding Palladone (hydromorphone hydrochloride extended-release capsules) in 12 mg, 16 mg, 24 mg, and 32 mg strengths for opioid-tolerant patients. The document presents the drug label and prescribing information for this Schedule II controlled-releas | Other | 2008-05-06 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.74
per ml
Lowest NADAC/Unit
$2.57
per ml
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 63323085325HYDROMORPHONE 2 MG/ML VIAL | $2.74 | ML | Generic | — | 2026-07-22 |
| 63323085115HYDROMORPHONE 50 MG/5 ML VIAL | $2.57 | ML | Generic | — | 2026-05-20 |
| 63323085150HYDROMORPHONE 500 MG/50 ML VL | $2.57 | ML | Generic | — | 2026-05-20 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.