ZEMDRI Drug Patent Profile

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

Summary for ZEMDRI

International Patents:	28
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	1
Patent Applications:	167
Drug Prices:	Drug price information for ZEMDRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEMDRI
DailyMed Link:	ZEMDRI at DailyMed

See drug prices for ZEMDRI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZEMDRI

NDA:

210303

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

Sponsor	Phase
Cipla USA Inc.	Phase 1

See all ZEMDRI clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ZEMDRI

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ZEMDRI

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

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

FDA Regulatory Exclusivity protecting ZEMDRI

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				Y
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes			Y
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes

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

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

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
European Patent Office	2217610	ANALOGUES D'AMINOGLYCOSIDES ANTIBACTÉRIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS)
China	103360440	Antibacterial aminoglycoside analogs
Brazil	PI0819319	Análogos de aminoglicosídeo antibacteriano