Viewing data from:

ZEMDRI

NDA

PLAZOMICIN SULFATE | N210303 | CIPLA USA INC

1 strength4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayExclusivity

2024

2025

2026

2027

2028

2029

2030

2031

2032

Today

Jun. 25, 2032

Nov. 21, 2028

Nov. 21, 2028

Nov. 21, 2028

NCE

Jun. 25, 2023

GAIN

Jun. 25, 2028

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 B Spending

CMS physician-administered drug spending for Zemdri (2023)

Total Spending

$129K

Total Claims

207

Beneficiaries

ASP Price

—

HCPCS: J0291 — Injection, plazomicin, 5 mg

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2023	SUPPL -7	View Letter (PDF)
Jul 20, 2020	SUPPL -5	View Letter (PDF)
Jun 26, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 500MG BASE/10ML (EQ 50MG BASE/ML)

RLD

4 patents2 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 25, 2018

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8383596	Jun 25, 2032	—	Yes	—		—
8822424	Nov 21, 2028	—	—	Yes	—	—
9266919	Nov 21, 2028	—	—	—		—
9688711	Nov 21, 2028	—	Yes	—		—

Exclusivities (2)

Code	Date	Status
GAIN	Jun 25, 2028	Active
NCE	Jun 25, 2023	Expired

Change History (2)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Cipla USA removed rapid susceptibility (RS) designation from plazomicin sulfate (Zemdri) NDA 210303.

Old: Yes

New: No

MODIFIEDtype7/1/2026

Cipla USA discontinued Zemdri (plazomicin sulfate), an injectable aminoglycoside antibiotic approved under NDA 210303, changing its product status from prescription to discontinued.

Old: RX

New: DISCN