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Generic Baxdela Availability

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

BAXDELA (delafloxacin meglumine - powder;iv (infusion))

  • Manufacturer: MELINTA
    Approval date: June 19, 2017
    Strength(s): EQ 300MG BASE/VIAL [RLD]

BAXDELA (delafloxacin meglumine - tablet;oral)

  • Manufacturer: MELINTA
    Approval date: June 19, 2017
    Strength(s): EQ 450MG BASE [RLD]

Has a generic version of Baxdela been approved?

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

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

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.

  • Sulfoalkyl ether cyclodextrin compositions
    Patent 7,635,773
    Issued: December 22, 2009
    Inventor(s): Antle; Vincent
    Assignee(s): CyDex Pharmaceuticals, Inc.
    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD composition comprises a sulfoalkyl ether cyclodextrin and less than 100 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
    Patent expiration dates:
    • March 13, 2029
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      Drug product
  • Salt and crystalline forms thereof of a drug
    Patent 7,728,143
    Issued: June 1, 2010
    Inventor(s): Zhang; Geoff G. Z. & Bradley; Michael F. & Barnes; David M. & Henry; Rodger
    Assignee(s): Abbott Laboratories
    A crystalline form of a drug, ways to make it, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.
    Patent expiration dates:
    • November 20, 2027
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      Drug substance
  • Salt and crystalline forms thereof of a drug
    Patent 8,252,813
    Issued: August 28, 2012
    Inventor(s): Zhang; Geoff G. Z. & Bradley; Michael F. & Barnes; David M. & Henry; Rodger
    Assignee(s): Abbott Laboratories
    A crystalline form of a drug, ways to make it, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.
    Patent expiration dates:
    • October 2, 2026
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      Patent use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
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      Drug product
  • Salt and crystalline forms thereof of a drug
    Patent 8,273,892
    Issued: September 25, 2012
    Inventor(s): Zhang; Geoff G. Z. & Bradley; Michael F. & Barnes; David M. & Henry; Rodger
    Assignee(s): Abbott Laboratories
    A crystalline form of a drug, ways to make it, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.
    Patent expiration dates:
    • August 6, 2026
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      Drug substance
  • Sulfoalkyl ether cyclodextrin compositions
    Patent 8,410,077
    Issued: April 2, 2013
    Assignee(s): CyDex Pharmaceuticals, Inc.
    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
    Patent expiration dates:
    • March 13, 2029
      ✓ 
      Drug product
  • Process for making quinolone compounds
    Patent 8,497,378
    Issued: July 30, 2013
    Assignee(s): Rib-X Pharmaceuticals, Inc.
    The present invention relates to the field of synthesizing anti-infective compounds. More particularly, the invention relates to synthesizing a family of quinolone compounds useful as anti-infective agents. The invention includes a process for preparing a quinolone compound wherein less than about 0.40% of dimeric impurity of the quinolone is produced.
    Patent expiration dates:
    • December 28, 2029
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      Drug substance
  • Salt and crystalline forms thereof of a drug
    Patent 8,648,093
    Issued: February 11, 2014
    Assignee(s): Abbvie Inc.
    A crystalline form of a drug, ways to make it, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.
    Patent expiration dates:
    • October 7, 2025
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      Patent use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
      ✓ 
      Drug product
  • Process for making quinolone compounds
    Patent 8,871,938
    Issued: October 28, 2014
    Assignee(s): Melinta Therapeutics, Inc.
    The present invention relates to the field of synthesizing anti-infective compounds. More particularly, the invention relates to synthesizing a family of quinolone compounds useful as anti-infective agents. The invention includes a process for preparing a quinolone compound wherein less than about 0.40% of dimeric impurity of the quinolone is produced.
    Patent expiration dates:
    • September 23, 2029
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      Drug substance
  • Salt and crystalline forms thereof of a drug
    Patent 8,969,569
    Issued: March 3, 2015
    Assignee(s): AbbVie Inc.
    A crystalline form of a drug, ways to make it, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.
    Patent expiration dates:
    • October 7, 2025
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      Patent use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
      ✓ 
      Drug product
  • Sulfoalkyl ether cyclodextrin compositions
    Patent 9,200,088
    Issued: December 1, 2015
    Assignee(s): Cydex Pharmaceuticals, Inc.
    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
    Patent expiration dates:
    • March 13, 2029
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      Drug product
  • Alkylated cyclodextrin compositions and processes for preparing and using the same
    Patent 9,493,582
    Issued: November 15, 2016
    Assignee(s): Cydex Pharmaceuticals, Inc.
    The present invention related to low-chloride alkylated cyclodextrin compositions, along with processes for preparing and using the same. The processes of the present invention provide alkylated cyclodextrins with low levels of drug-degrading agents and chloride.
    Patent expiration dates:
    • February 27, 2033
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      Drug product
  • Salt and crystalline forms thereof of a drug
    Patent 9,539,250
    Issued: January 10, 2017
    Assignee(s): ABBVIE INC.
    A crystalline form of a drug, ways to make it, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.
    Patent expiration dates:
    • October 7, 2025
      ✓ 
      Patent use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Sulfoalkyl ether cyclodextrin compositions
    Patent 9,750,822
    Issued: September 5, 2017
    Assignee(s): Cydex Pharmaceuticals, Inc.
    SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
    Patent expiration dates:
    • March 13, 2029
      ✓ 
      Drug product
  • Process for making quinolone compounds
    Patent RE46617
    Issued: November 28, 2017
    Assignee(s): MELINTA THERAPEUTICS, INC.
    The present invention relates to the field of synthesizing anti-infective compounds. More particularly, the invention relates to synthesizing a family of quinolone compounds useful as anti-infective agents. The invention includes a process for preparing a quinolone compound wherein less than about 0.40% of dimeric impurity of the quinolone is produced.
    Patent expiration dates:
    • December 28, 2029
      ✓ 
      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 19, 2022 - NEW CHEMICAL ENTITY
    • June 19, 2027 - GENERATING ANTIBIOTIC INCENTIVES NOW
Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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