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Last Updated: June 18, 2024

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ZEMDRI Drug Patent Profile


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When do Zemdri patents expire, and what generic alternatives are available?

Zemdri is a drug marketed by Cipla Usa and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-eight patent family members in twenty-one countries.

The generic ingredient in ZEMDRI is plazomicin sulfate. Three suppliers are listed for this compound. Additional details are available on the plazomicin sulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Zemdri

Zemdri was eligible for patent challenges on June 25, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 2, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for ZEMDRI
Drug Prices for ZEMDRI

See drug prices for ZEMDRI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEMDRI
Generic Entry Date for ZEMDRI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZEMDRI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cipla USA Inc.Phase 1

See all ZEMDRI clinical trials

US Patents and Regulatory Information for ZEMDRI

ZEMDRI is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEMDRI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZEMDRI

Antibacterial aminoglycoside analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

Antibacterial aminoglycoside analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antibacterial aminoglycoside analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

Antibacterial aminoglycoside analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

FDA Regulatory Exclusivity protecting ZEMDRI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ZEMDRI

When does loss-of-exclusivity occur for ZEMDRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08326297
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0819319
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 06369
Estimated Expiration: ⤷  Sign Up

China

Patent: 1868472
Estimated Expiration: ⤷  Sign Up

Patent: 3360440
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0170154
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 18915
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 17610
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 7824
Estimated Expiration: ⤷  Sign Up

Patent: 1070597
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 17610
Estimated Expiration: ⤷  Sign Up

Patent: 50617
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 30523
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5880
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 86310
Estimated Expiration: ⤷  Sign Up

Patent: 11219498
Estimated Expiration: ⤷  Sign Up

Patent: 11504508
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 17610
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10005632
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 17610
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 17610
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 17610
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1296099
Estimated Expiration: ⤷  Sign Up

Patent: 100110297
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 13936
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 25947
Estimated Expiration: ⤷  Sign Up

Patent: 0927146
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZEMDRI around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 201070597 АНТИБАКТЕРИАЛЬНЫЕ АНАЛОГИ АМИНОГЛИКОЗИДА ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2009067692 ⤷  Sign Up
South Korea 101296099 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.