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Last Updated: May 26, 2022

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. Two suppliers are listed for this compound. Additional details are available on the plazomicin sulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Zemdri

Zemdri will be eligible for patent challenges on June 25, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

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DrugPatentWatch® Estimated Generic Entry Opportunity 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

Antibacterial aminoglycoside analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antibacterial aminoglycoside analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

Antibacterial aminoglycoside analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

FDA Regulatory Exclusivity protecting ZEMDRI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla Usa ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303-001 Jun 25, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 0819319
Estimated Expiration: See Plans and Pricing

Canada

Patent: 06369
Estimated Expiration: See Plans and Pricing

China

Patent: 1868472
Estimated Expiration: See Plans and Pricing

Patent: 3360440
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170154
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18915
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 17610
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7824
Estimated Expiration: See Plans and Pricing

Patent: 1070597
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 17610
Estimated Expiration: See Plans and Pricing

Patent: 50617
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30523
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5880
Estimated Expiration: See Plans and Pricing

Japan

Patent: 86310
Estimated Expiration: See Plans and Pricing

Patent: 11219498
Estimated Expiration: See Plans and Pricing

Patent: 11504508
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 17610
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10005632
Estimated Expiration: See Plans and Pricing

Poland

Patent: 17610
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 17610
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 17610
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1296099
Estimated Expiration: See Plans and Pricing

Patent: 100110297
Estimated Expiration: See Plans and Pricing

Spain

Patent: 13936
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 25947
Estimated Expiration: See Plans and Pricing

Patent: 0927146
Estimated Expiration: See Plans and Pricing

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
Japan 4986310 See Plans and Pricing
European Patent Office 3150617 ANALOGUES D'AMINOGLYCOSIDES ANTIBACTÉRIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS) See Plans and Pricing
Japan 2011504508 See Plans and Pricing
Croatia P20170154 See Plans and Pricing
Poland 2217610 See Plans and Pricing
European Patent Office 2217610 ANALOGUES D'AMINOGLYCOSIDES ANTIBACTÉRIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Moodys
Baxter
Boehringer Ingelheim
AstraZeneca

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.