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ERYTHROCIN

NDA

ERYTHROMYCIN LACTOBIONATE | N050182 | HOSPIRA INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Erythrocin Lactobionate (2023)

Total Spending

$64K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$30.23

Spending Trend

$26K(2019)→$31K(2020)→$39K(2021)→$17K(2022)→$64K(2023)

YoY Change:+83.7%

5yr CAGR:-21.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Erythrocin Lactobionate (2023)

Total Spending

$8K

Total Claims

Beneficiaries

ASP Price

—

HCPCS: J1364 — Injection, erythromycin lactobionate, per 500 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

APITORIA PHARMA PRIVATE LTDERYTHROMYCIN LACTOBIONATE

DMF 340722019

GLAND PHARMA LTDERYTHROMYCIN LACTOBIONATE

DMF 344262019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDERYTHROMYCIN LACTOBIONATE

DMF 347502020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 17, 2004	SUPPL -125	View Letter (PDF)
May 23, 2002	SUPPL -122	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — EQ 1GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982