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Generic Nuzyra Availability

Last updated on Sep 8, 2021.

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

NUZYRA (omadacycline tosylate - powder;intravenous)

  • Manufacturer: PARATEK PHARMS INC
    Approval date: October 2, 2018
    Strength(s): EQ 100MG BASE/VIAL [RLD]

NUZYRA (omadacycline tosylate - tablet;oral)

  • Manufacturer: PARATEK PHARMS INC
    Approval date: October 2, 2018
    Strength(s): EQ 150MG BASE [RLD]

Has a generic version of Nuzyra been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nuzyra. 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.

  • 9-aminomethyl minocycline compounds and uses thereof
    Patent 10,111,890
    Issued: October 30, 2018
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein the 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline is administered orally at a dose of about 450 mg per day for two consecutive days, then at a dose of about 300 mg per day for 5 or more days.

    Patent expiration dates:

    • August 3, 2037
      ✓ 
      Patent use: TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION
  • Minocycline compounds and methods of use thereof
    Patent 10,124,014
    Issued: November 13, 2018
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said infection is selected from the group consisting of MSSA, MRSA, B-streptococci, Viridans Streptococci, Enterococcus, or combinations thereof.

    Patent expiration dates:

    • March 5, 2029
      ✓ 
      Patent use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION
  • Patent 10,383,884

    Patent expiration dates:

    • October 31, 2037
      ✓ 
      Patent use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
  • Patent 10,835,542

    Patent expiration dates:

    • October 31, 2037
      ✓ 
      Patent use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
  • Amino-methyl substituted tetracycline compounds
    Patent 7,326,696
    Issued: February 5, 2008
    Inventor(s): Nelson; Mark L. & Ohemeng; Kwasi & Frechette; Roger & Abato; Paul & Amoo; Victor & Assefa; Haregewein & Berniac; Joel & Bhatia; Beena & Bowser; Todd & Chen; Jackson & Honeyman; Laura & Ismail; Mohamed Y. & Kim; Oak & Mechiche; Rachid & Reddy; N. Laxma & Verma; Atul K. & Viski; Peter & War
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Aminomethyl substituted tetracycline compounds, pharmaceutical compositions, and methods of use thereof are discussed.

    Patent expiration dates:

    • September 24, 2023
      ✓ 
      Drug substance
  • 9-aminomethyl substituted minocycline compounds
    Patent 7,553,828
    Issued: June 30, 2009
    Inventor(s): Nelson; Mark L. & Frechette; Roger & Ismail; Mohamed Y. & Honeyman; Laura & Bowser; Todd & Bhatia; Beena
    Assignee(s): Paratek Pharmaceuticals, Inc.

    The present invention pertains, at least in part, to novel 9-substituted minocycline compounds. These minocycline compounds can be used to treat numerous tetracycline compound-responsive states, such as bacterial infections and neoplasms, as well as other known applications for minocycline and minocycline compounds in general, such as blocking tetracycline efflux and modulation of gene expression.

    Patent expiration dates:

    • June 2, 2023
      ✓ 
      Drug substance
  • Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline
    Patent 8,383,610
    Issued: February 26, 2013
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Crystalline forms, including salts and polymorphs, of a compound useful in the treatment of tetracycline compound-responsive states are provided herein. The crystalline compounds are useful for the treatment or prevention of conditions and disorders such as bacterial infections and neoplasms, as well as other known applications for tetracycline compounds in general.

    Patent expiration dates:

    • September 23, 2030
      ✓ 
      Drug substance
  • Minocycline compounds and methods of use thereof
    Patent 9,265,740
    Issued: February 23, 2016
    Assignee(s): Paratek Pharmaceuticals, Inc.-124418

    Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said infection is selected from the group consisting of MSSA, MRSA, B-streptococci, Viridans Streptococci, Enterococcus, or combinations thereof.

    Patent expiration dates:

    • March 5, 2029
      ✓ 
      Drug product
    • March 5, 2029
      ✓ 
      Patent use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
  • Oral and injectable formulations of tetracycline compounds
    Patent 9,314,475
    Issued: April 19, 2016
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Injectable and oral formulations of a tetracycline compound are described. In one embodiment, the invention pertains to an oral formulation of a 9-aminomethyl tetracycline compound, or a salt thereof, in tablet form or capsule. The formulations may be used, for example, to treat infections.

    Patent expiration dates:

    • March 18, 2031
      ✓ 
      Drug product
  • 9-aminomethyl substituted minocycline compounds
    Patent 9,365,500
    Issued: June 14, 2016
    Assignee(s): PARATEK PHARMACEUTICALS, INC.

    The present invention pertains, at least in part, to novel 9-substituted minocycline compounds. These minocycline compounds can be used to treat numerous tetracycline compound-responsive states, such as bacterial infections and neoplasms, as well as other known applications for minocycline and minocycline compounds in general, such as blocking tetracycline efflux and modulation of gene expression.

    Patent expiration dates:

    • June 29, 2021
      ✓ 
      Patent use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
    • June 29, 2021
      ✓ 
      Patent use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
  • Minocycline compounds and methods of use thereof
    Patent 9,724,358
    Issued: August 8, 2017
    Assignee(s): Paratek Pharmaceuticals, Inc.

    Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said infection is selected from the group consisting of MSSA, MRSA, B-streptococci, Viridans Streptococci, Enterococcus, or combinations thereof.

    Patent expiration dates:

    • March 5, 2029
      ✓ 
      Patent use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

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:

    • October 2, 2023 - NEW CHEMICAL ENTITY
    • October 2, 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.