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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

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)NCT01096849	Phase 2	Completed	Achaogen, Inc.	145	2010-07-13 → 2012-04-03
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)NCT01970371	Phase 3	Completed	Achaogen, Inc.	69	2014-09-16 → 2016-09-15
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)NCT02486627	Phase 3	Completed	Achaogen, Inc.	609	2016-01-11 → 2016-09-22

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$2529.06

Highest Price

$2529.06

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
80735-0820-96ZEMDRI 50MG/ML INJ,SOLN	$2529.06	FSS	Cipla USA, Inc.	08/14/2026
69097-0820-96ZEMDRI 50MG/ML INJ,SOLN	$2529.06	FSS	Cipla USA, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part B Spending

CMS physician-administered drug spending for Zemdri (2024)

Total Spending

$165K

Total Claims

227

Beneficiaries

ASP Price

$3.60

Spending Trend

$40K(2019)→$265K(2020)→$237K(2021)→$125K(2022)→$129K(2023)→$165K(2024)

YoY Change:+5.2%

5yr CAGR:+3.3%

HCPCS: J0291 — Injection, plazomicin, 5 mg

Source: CMS Medicare Part B Spending by Drug (2024). 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) · 3 use codes

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