VANCOMYCIN HYDROCHLORIDE | N208910 | AZURITY PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Azurity Pharmaceuticals, Inc. v. ANI Pharmaceuticals, Inc. 1 patentvancomycin hydrochloride | D. Minn. | 2021-03-24 | Terminated 2022-02-22 | — |
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd. 1 patentANDA 214913vancomycin hydrochloride | D. Del. | 2020-08-20 | Terminated 2023-05-04 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - Vancomycin Hydrochloride for Injection, USP RE Suitability Pet... FDA-2023-P-4334 · 7 docket documents Hospira, Inc. filed a citizen petition requesting that the FDA declare vancomycin hydrochloride for injection, USP as suitable for use in the pharmaceutical compendium, addressing regulatory requirements for this injectable antibiotic product. | Suitability | 2023-10-04 | Granted | Hospira, Inc |
ATTACHMENT 3: Draft Package Insert Proposed for Vancomycin Hydrochloride for ... FDA-2020-P-2187 · 6 docket documents Lachman Consulting Services, Inc. filed a citizen petition requesting FDA approval to add a new strength of 125 mg (base)/5 mL to the vancomycin hydrochloride oral solution product line, with the submission including a draft package insert for the proposed additional strength formulation. | Suitability | 2020-11-16 | Withdrawn | Lachman Consulting Services, Inc. |
Olsson, Frank, Weeda (OFW) et al Law PC - Citizen Petition FDA-2013-P-1202 · 3 docket documents On September 26, 2013, the law firm Olsson Frank Weeda Terman Matz PC filed a citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine a new strength of Vancomycin Hydrochloride For Injection, USP (1.5 grams base per vial) is suitable | Other | 2013-10-28 | Granted | — |
Suitability Petition Supplement from King & Spalding LLP FDA-2006-P-0344 · 5 docket documents King & Spalding LLP filed supplements to two suitability petitions for Vancomycin HCl USP 750 mg formulations in both Fliptop Vial and ADD-Vantage Vial presentations. The petitioner requested FDA approval under 21 U.S.C. § 355(j)(2)(C) to establish these intermediate-strength vials as suitable for a | Suitability | 2008-11-15 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.19
per ml
Lowest NADAC/Unit
$0.4082
per ml
Brand NDCs
1
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 65628020605FIRVANQ 50 MG/ML SOLUTION | $1.19 | ML | Brand | $0.7193 | 2026-01-01 |
| 52536010810VANCOMYCIN 50 MG/ML ORAL SOLN | $0.8007 | ML | Generic | — | 2025-12-17 |
| 52536010605VANCOMYCIN 50 MG/ML ORAL SOLN | $0.7193 | ML | Generic | — | 2026-06-17 |
| 52536010405VANCOMYCIN 25 MG/ML ORAL SOLN | $0.6625 | ML | Generic | — | 2026-06-17 |
| 52536010710VANCOMYCIN 25 MG/ML ORAL SOLN | $0.4082 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.