DrugPatentWatch Database Preview
ZEMDRI Drug Profile
» See Plans and Pricing
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
Summary for ZEMDRI
| International Patents: | 28 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 1 |
| Patent Applications: | 104 |
| Drug Prices: | Drug price information for ZEMDRI |
| DailyMed Link: | ZEMDRI at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Cipla USA Inc. | Phase 1 |
US Patents and Regulatory Information for 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 | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0819319 | Get Started for $10 |
| Cyprus | 1118915 | Get Started for $10 |
| Japan | 2011504508 | Get Started for $10 |
| Australia | 2008326297 | Get Started for $10 |
| China | 103360440 | Get Started for $10 |
| European Patent Office | 3150617 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
