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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.
US ANDA Litigation and 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.
There is one tentative approval for the generic drug (plazomicin sulfate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for ZEMDRI
| International Patents: | 28 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 7 |
| Patent Applications: | 7 |
| Drug Prices: | Drug price information for ZEMDRI |
| DailyMed Link: | ZEMDRI at DailyMed |
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.
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2217610 | Start Trial |
| European Patent Office | 2217610 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009067692 | Start Trial |
| Australia | 2008326297 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
