TheraRadar
Data updated: May 26, 2026

ZEMDRI (plazomicin sulfate)

Infectious Disease Approved 2018-06-25

ZEMDRI is indicated for the treatment of Complicated Urinary Tract Infection; Pyelonephritis.

Source: FDA Label • Cipla
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market

Details

Status
Prescription
First Approved
2018-06-25
Patent Cliff
2032

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: PLAZOMICIN SULFATE

ZEMDRI Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2018 to 2023
Feb 2023 SUPPL
Label · Labeling
Jul 2020 SUPPL
Label · Labeling
Jun 2018 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity

What ZEMDRI Treats

2 indications

ZEMDRI is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Complicated Urinary Tract Infection
  • Pyelonephritis
Source: FDA Label

ZEMDRI Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ZEMDRI

3 of 13

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

FETROJA
CEFIDEROCOL SULFATE TOSYLATE
2 shared
SHIONOGI
Shared indications:
Complicated Urinary Tract InfectionPyelonephritis
RECARBRIO
CILASTATIN SODIUM
2 shared
Merck
Shared indications:
Complicated Urinary Tract InfectionPyelonephritis
VABOMERE
MEROPENEM
2 shared
REMPEX
Shared indications:
Complicated Urinary Tract InfectionPyelonephritis
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZEMDRI FDA Label Details

Indications & Usage

FDA Label (PDF)

ZEMDRI is indicated for the treatment of Complicated Urinary Tract Infection; Pyelonephritis.

View full patent landscape →
4 OB patents · 1 families · 47 international docs across 22 countries

ZEMDRI Patents & Exclusivity

Latest Patent: Jun 2032
Exclusivity: Jun 2028

Patents (4 active)

US8383596 Expires Jun 25, 2032
US9688711 Expires Nov 21, 2028
US9266919 Expires Nov 21, 2028
US8822424 Expires Nov 21, 2028

Exclusivity

NCE Until Jun 2023
GAIN Until Jun 2028
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • Cliff: 2032
  • 4 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 13 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.