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ILOTYCIN GLUCEPTATE

NDA

ERYTHROMYCIN GLUCEPTATE | N050370 | DISTA PRODUCTS CO DIV ELI LILLY AND CO

3 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

7 trials from ClinicalTrials.gov — 3 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Incidence of Acute Laryngeal Injury Following Endotracheal Intubation NCT03250975	Phase 1/2	Active	Vanderbilt University Medical Center	64	2017-08-19 → 2026-12-30
Extended Azithromycin Treatment in Prelabor Rupture of Membranes NCT07669207	Phase 4	Not Yet Recruiting	Alexa Henderson	30	2026-07-01 → 2028-07
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams NCT07164131	Phase 4	Recruiting	Mayo Clinic	1,120	2025-09-15 → 2031-09-01
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction NCT06082037	Phase 3	Recruiting	Sanofi	180	2023-10-10 → 2030-10-01
A Study of Standard Drugs for Mycobacterium Avium Complex NCT04287049	Phase 2	Completed	Johns Hopkins University	10	2020-02-24 → 2025-03-21
Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection NCT04339426	Phase 2	Terminated	HonorHealth Research Institute	3	2020-04-20 → 2022-02-11
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department NCT04669288	Phase 3	Terminated	University of Arizona	840	2021-11-22 → 2025-01-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Products (3)

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#001 — EQ 250MG BASE/VIAL

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▾

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

#003 — EQ 1GM BASE/VIAL

0 patents0 exclusivities▾

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