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Generic Byfavo Availability

Last updated on Sep 8, 2021.

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

BYFAVO (remimazolam besylate - powder;intravenous)

  • Manufacturer: ACACIA
    Approval date: October 6, 2020
    Strength(s): EQ 20MG BASE/VIAL [RLD]

Has a generic version of Byfavo been approved?

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

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

  • Dosing regimen for sedation with CNS 7056 (remimazolam)
    Patent 10,052,334
    Issued: August 21, 2018
    Assignee(s): PAION UK LTD.

    The invention relates to a dosing regimen for sedation with the fast-acting benzodiazepine CNS 7056 in combination with an opioid, in particular fentanyl, whereas CNS 7056 is given in a dose of 2 to 20 mg, preferably between 4 and 9 mg and most preferably between 5 and 8 mg.

    Patent expiration dates:

    • November 7, 2031
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Dosing regimen for sedation with CNS 7056 (Remimazolam)
    Patent 10,195,210
    Issued: February 5, 2019
    Assignee(s): PAION UK LTD.

    The invention relates to a dosing regimen for sedation with the fast-acting benzodiazepine CNS 7056 in combination with an opioid, in particular fentanyl, whereas CNS 7056 is given in a dose of 2 to 20 mg, preferably between 4 and 9 mg and most preferably between 5 and 8 mg.

    Patent expiration dates:

    • November 7, 2031
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Dosing regimen for sedation with CNS 7056 (Remimazolam)
    Patent 10,342,800
    Issued: July 9, 2019
    Assignee(s): PAION UK LTD.

    The invention relates to a dosing regimen for sedation with the fast-acting benzodiazepine CNS 7056 in combination with an opioid, in particular fentanyl, whereas CNS 7056 is given in a dose of 2 to 20 mg, preferably between 4 and 9 mg and most preferably between 5 and 8 mg.

    Patent expiration dates:

    • November 7, 2031
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Patent 10,472,365

    Patent expiration dates:

    • July 10, 2027
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Patent 10,722,522

    Patent expiration dates:

    • November 7, 2031
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Dosing regimen for sedation with CNS 7056 (Remimazolam)
    Patent 9,561,236
    Issued: February 7, 2017
    Assignee(s): PAION UK LTD.

    The invention relates to a dosing regimen for sedation with the fast-acting benzodiazepine CNS 7056 in combination with an opioid, in particular fentanyl, whereas CNS 7056 is given in a dose of 2 to 20 mg, preferably between 4 and 9 mg and most preferably between 5 and 8 mg.

    Patent expiration dates:

    • April 30, 2033
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Dosing regimen for sedation with CNS 7056 (Remimazolam)
    Patent 9,737,547
    Issued: August 22, 2017
    Assignee(s): PAION UK LIMITED

    The invention relates to a dosing regimen for sedation with the fast-acting benzodiazepine CNS 7056 in combination with an opioid, in particular fentanyl, whereas CNS 7056 is given in a dose of 2 to 20 mg, preferably between 4 and 9 mg and most preferably between 5 and 8 mg.

    Patent expiration dates:

    • November 7, 2031
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Short-acting benzodiazepine salts and their polymorphic forms
    Patent 9,777,007
    Issued: October 3, 2017
    Assignee(s): PAION UK LIMITED

    The invention relates to besylate salts of the compound of formula (I): Methods of preparing the salts, and their use as medicaments, in particular for sedative or hypnotic, anxiolytic, muscle relaxant, or anticonvulsant purposes is also described.

    Patent expiration dates:

    • July 10, 2027
      ✓ 
      Drug product
  • Dosing regimen for sedation with CNS 7056 (remimazolam)
    Patent 9,827,251
    Issued: November 28, 2017
    Assignee(s): PAION UK LTD.

    The invention relates to a dosing regimen for sedation with the fast-acting benzodiazepine CNS 7056 in combination with an opioid, in particular fentanyl, whereas CNS 7056 is given in a dose of 2 to 20 mg, preferably between 4 and 9 mg and most preferably between 5 and 8 mg.

    Patent expiration dates:

    • November 7, 2031
      ✓ 
      Patent use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
  • Short-acting benzodiazepine salts and their polymorphic forms
    Patent 9,914,738
    Issued: March 13, 2018
    Assignee(s): PAION UK LIMITED

    The invention relates to besylate salts of the compound of formula (I): Methods of preparing the salts, and their use as medicaments, in particular for sedative or hypnotic, anxiolytic, muscle relaxant, or anticonvulsant purposes is also described.

    Patent expiration dates:

    • July 10, 2027
      ✓ 
      Drug product

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 6, 2025 - NEW CHEMICAL ENTITY

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.