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
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 |


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
Sponsor | Phase |
---|---|
Cipla USA Inc. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for ZEMDRI
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
Antibacterial aminoglycoside analogs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Antibacterial aminoglycoside analogs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
Antibacterial aminoglycoside analogs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
FDA Regulatory Exclusivity protecting ZEMDRI
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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: ⤷ Try a Trial
Brazil
Patent: 0819319
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 06369
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1868472
Estimated Expiration: ⤷ Try a Trial
Patent: 3360440
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0170154
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 18915
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 17610
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7824
Estimated Expiration: ⤷ Try a Trial
Patent: 1070597
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 17610
Estimated Expiration: ⤷ Try a Trial
Patent: 50617
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 30523
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5880
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 86310
Estimated Expiration: ⤷ Try a Trial
Patent: 11219498
Estimated Expiration: ⤷ Try a Trial
Patent: 11504508
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 17610
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 10005632
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 17610
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 17610
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 17610
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1296099
Estimated Expiration: ⤷ Try a Trial
Patent: 100110297
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 13936
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 25947
Estimated Expiration: ⤷ Try a Trial
Patent: 0927146
Estimated Expiration: ⤷ Try a Trial
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) | ⤷ Try a Trial |
China | 103360440 | Antibacterial aminoglycoside analogs | ⤷ Try a Trial |
Brazil | PI0819319 | Análogos de aminoglicosídeo antibacteriano | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |