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Generic Zemdri Availability

Last updated on June 8, 2021.

Zemdri is a brand name of plazomicin, approved by the FDA in the following formulation(s):

ZEMDRI (plazomicin sulfate - solution;intravenous)

  • Manufacturer: CIPLA USA
    Approval date: June 25, 2018
    Strength(s): EQ 500MG BASE/10ML (EQ 50MG BASE/ML) [RLD]

Has a generic version of Zemdri been approved?

No. There is currently no therapeutically equivalent version of Zemdri available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zemdri. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Antibacterial aminoglycoside analogs
    Patent 8,383,596
    Issued: February 26, 2013
    Assignee(s): Achaogen, Inc.

    Compounds having antibacterial activity are disclosed. The compounds have the following structure (I): including stereoisomers, pharmaceutically acceptable salts and prodrugs thereof, wherein Q1, Q2, Q3, R8 and R9 are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed.

    Patent expiration dates:

    • June 2, 2031
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      Patent use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
      ✓ 
      Drug substance
  • Antibacterial aminoglycoside analogs
    Patent 8,822,424
    Issued: September 2, 2014
    Assignee(s): Achaogen, Inc.

    Compounds having antibacterial activity are disclosed. The compounds have the following structure (I): including stereoisomers, pharmaceutically acceptable salts and prodrugs thereof, wherein Q1, Q2, Q3, R8 and R9 are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed.

    Patent expiration dates:

    • November 21, 2028
      ✓ 
      Drug product
  • Antibacterial aminoglycoside analogs
    Patent 9,266,919
    Issued: February 23, 2016
    Assignee(s): Achaogen, Inc.

    Compounds having antibacterial activity are disclosed. The compounds have the following structure (I): including stereoisomers, pharmaceutically acceptable salts and prodrugs thereof, wherein Q1, Q2, Q3, R8 and R9 are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed.

    Patent expiration dates:

    • November 21, 2028
      ✓ 
      Patent use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
  • Antibacterial aminoglycoside analogs
    Patent 9,688,711
    Issued: June 27, 2017
    Assignee(s): Achaogen, Inc.

    Compounds having antibacterial activity are disclosed. The compounds have the following structure (I): including stereoisomers, pharmaceutically acceptable salts and prodrugs thereof, wherein Q1, Q2, Q3, R8 and R9 are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed.

    Patent expiration dates:

    • November 21, 2028
      ✓ 
      Patent use: METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
      ✓ 
      Drug substance

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • June 25, 2023 - NEW CHEMICAL ENTITY
    • June 25, 2028 - GENERATING ANTIBIOTIC INCENTIVES NOW

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.