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Plazomicin sulfate - Generic Drug Details
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What are the generic drug sources for plazomicin sulfate and what is the scope of patent protection?
Plazomicin sulfate
is the generic ingredient in one branded drug marketed by Cipla Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Plazomicin sulfate has twenty-eight patent family members in twenty-one countries.
Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for plazomicin sulfate
| International Patents: | 28 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| DailyMed Link: | plazomicin sulfate at DailyMed |
Generic filers with tentative approvals for PLAZOMICIN SULFATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | SOLUTION;INTRAVENOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for plazomicin sulfate
| 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 | 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 | ||||
| >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 plazomicin sulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2009067692 | Start Trial |
| Slovenia | 2217610 | Start Trial |
| Taiwan | I425947 | Start Trial |
| Lithuania | 2217610 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
