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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Summary for ZEMDRI
| International Patents: | 28 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 1 |
| Patent Applications: | 107 |
| 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
*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 |
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 | ||||
| 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 | ||||
| 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
Patent: Antibacterial aminoglycoside analogs
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0819319
Patent: Análogos de aminoglicosídeo antibacteriano
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 06369
Patent: ANALOGUES D'AMINOGLYCOSIDES ANTIBACTERIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1868472
Patent: Antibacterial aminoglycoside analogs
Estimated Expiration: ⤷ Sign Up
Patent: 3360440
Patent: Antibacterial aminoglycoside analogs
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
Patent: АНТИБАКТЕРИАЛЬНЫЕ АНАЛОГИ АМИНОГЛИКОЗИДА (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS)
Estimated Expiration: ⤷ Sign Up
Patent: 1070597
Patent: АНТИБАКТЕРИАЛЬНЫЕ АНАЛОГИ АМИНОГЛИКОЗИДА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 17610
Patent: ANALOGUES D'AMINOGLYCOSIDES ANTIBACTÉRIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS)
Estimated Expiration: ⤷ Sign Up
Patent: 50617
Patent: ANALOGUES D'AMINOGLYCOSIDES ANTIBACTÉRIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 30523
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5880
Patent: אנלוגי אמינוגליקוזידים, תכשירים המכילים אותם ושימושים בהם (Aminoglycoside analogs, compositions comprising the same and uses thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 86310
Estimated Expiration: ⤷ Sign Up
Patent: 11219498
Patent: ANTIBACTERIAL AMINOGLYCOSIDE ANALOG
Estimated Expiration: ⤷ Sign Up
Patent: 11504508
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 17610
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10005632
Patent: ANALOGOS DE AMINOGLUCOSIDOS ANTIBACTERIANOS. (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS.)
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
Patent: ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 13936
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 25947
Estimated Expiration: ⤷ Sign Up
Patent: 0927146
Patent: Antibacterial aminoglycoside analogs
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 |
|---|---|---|---|
| Slovenia | 2217610 | ⤷ Sign Up | |
| Portugal | 2217610 | ⤷ Sign Up | |
| European Patent Office | 3150617 | ANALOGUES D'AMINOGLYCOSIDES ANTIBACTÉRIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS) | ⤷ Sign Up |
| Japan | 2011504508 | ⤷ Sign Up | |
| Canada | 2706369 | ANALOGUES D'AMINOGLYCOSIDES ANTIBACTERIENS (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS) | ⤷ Sign Up |
| Australia | 2008326297 | Antibacterial aminoglycoside analogs | ⤷ Sign Up |
| Japan | 4986310 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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