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Generic Kybella Availability

Last updated on July 7, 2021.

Kybella is a brand name of deoxycholic acid, approved by the FDA in the following formulation(s):

KYBELLA (deoxycholic acid - solution;subcutaneous)

  • Manufacturer: KYTHERA BIOPHARMS
    Approval date: April 29, 2015
    Strength(s): 20MG/2ML (10MG/ML) [RLD] [AP]

Has a generic version of Kybella been approved?

A generic version of Kybella has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Kybella and have been approved by the FDA:

deoxycholic acid solution;subcutaneous

  • Manufacturer: SLAYBACK PHARMA LLC
    Approval date: April 2, 2021
    Strength(s): 20MG/2ML (10MG/ML) [AP]

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

  • Patent 10,500,214

    Patent expiration dates:

    • March 2, 2030
      ✓ 
      Drug product
  • Methods and compositions for the non-surgical removal of fat
    Patent 7,622,130
    Issued: November 24, 2009
    Inventor(s): Kolodney; Michael S. & Rotunda; Adam M.
    Assignee(s): Los Angeles Biomedical Research Institute at Harbor UCLA-Medical Center The Regents of the University of California

    Compositions and methods useful in the non-surgical removal of localized fat deposits in patients in need thereof using pharmacologically active detergents are disclosed. The pharmacologically active detergent compositions can additionally include anti-inflammatory agents, analgesics, dispersion agents and pharmaceutically acceptable excipients but do not contain phosphotidylcholine. The pharmacologically active detergent compositions are useful for treating localized accumulations of fat including lower eyelid fat herniation, lipodystrophy and fat deposits associated with cellulite and do not require surgical procedures such as liposuction.

    Patent expiration dates:

    • December 10, 2027
      ✓ 
      Patent use: METHOD FOR REDUCTION OF SUBMENTAL FAT
  • Methods and related compositions for reduction of fat
    Patent 7,754,230
    Issued: July 13, 2010
    Inventor(s): Kolodney; Michael S. & Rotunda; Adam M.
    Assignee(s): The Regents of the University of California Los Angeles Biomed. Res. Inst. at Harbor UCLA Medical Center

    Compositions and methods useful in the reduction of localized fat deposits in patients in need thereof using pharmacologically active detergents are disclosed. The pharmacologically active detergent compositions can additionally include anti-inflammatory agents, analgesics, dispersion or anti-dispersion agents and pharmaceutically acceptable excipients. The pharmacologically active detergent compositions are useful for treating localized accumulations of fat including, for example, lower eyelid fat herniation, lipodystrophy and fat deposits associated with cellulite and do not require surgical procedures such as liposuction.

    Patent expiration dates:

    • December 10, 2027
      ✓ 
      Patent use: METHOD FOR REDUCTION OF SUBMENTAL FAT
  • Formulations of deoxycholic acid and salts thereof
    Patent 8,101,593
    Issued: January 24, 2012
    Inventor(s): Hodge; Robert Emil & Webster; Jeffrey Douglas
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.

    Patent expiration dates:

    • March 2, 2030
      ✓ 
      Drug product
  • Synthetic bile acid compositions and methods
    Patent 8,242,294
    Issued: August 14, 2012
    Inventor(s): Moriarty; Robert M. & David; Nathaniel E. & Mahmood; Nadir Ahmeduddin
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

    Patent expiration dates:

    • May 16, 2028
      ✓ 
      Drug substance
  • Methods and related compositions for the non-surgical removal of fat
    Patent 8,298,556
    Issued: October 30, 2012
    Inventor(s): Kolodney; Michael S. & Rotunda; Adam M.
    Assignee(s): The Regents of the University of California Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Compositions and methods useful in the non-surgical removal of localized fat deposits in patients in need thereof using pharmacologically active detergents are disclosed. The pharmacologically active detergent compositions can additionally include anti-inflammatory agents, analgesics, dispersion agents and pharmaceutically acceptable excipients but do not contain phosphotidylcholine. The pharmacologically active detergent compositions are useful for treating localized accumulations of fat including lower eyelid fat herniation, lipodystrophy and fat deposits associated with cellulite and do not require surgical procedures such as liposuction.

    Patent expiration dates:

    • August 3, 2025
      ✓ 
      Patent use: METHOD FOR REDUCTION OF SUBMENTAL FAT
  • Formulations of deoxycholic acid and salts thereof
    Patent 8,367,649
    Issued: February 5, 2013
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.

    Patent expiration dates:

    • March 2, 2030
      ✓ 
      Drug product
  • Synthetic bile acid compositions and methods
    Patent 8,461,140
    Issued: June 11, 2013
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

    Patent expiration dates:

    • February 21, 2028
      ✓ 
      Drug product
  • Synthetic bile acid compositions and methods
    Patent 8,546,367
    Issued: October 1, 2013
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

    Patent expiration dates:

    • February 21, 2028
      ✓ 
      Patent use: METHOD FOR REDUCTION OF SUBMENTAL FAT
      ✓ 
      Drug product
  • Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits
    Patent 8,653,058
    Issued: February 18, 2014
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    The present application is directed to an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid, wherein the composition is maintained at a pH from about 8.1 to about 8.5 such that the composition is stabilized against precipitation. Also disclosed herein, are methods for stabilizing an aqueous pharmaceutical composition comprising from about 0.4% w/v to less than about 2% w/v of a salt of deoxycholic acid against precipitation, said method comprising maintaining pH of the solution from about 8.1 to about 8.5.

    Patent expiration dates:

    • March 2, 2030
      ✓ 
      Drug product
  • Methods and related compositions for reduction of fat and skin tightening
    Patent 8,846,066
    Issued: September 30, 2014
    Assignee(s): The Regents of the University of California Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Compositions and methods useful in the reduction of localized fat deposits and tightening of loose skin in subjects in need thereof using pharmacologically active detergents are disclosed. The pharmacologically active detergent compositions can additionally include anti-inflammatory agents, analgesics, dispersion or anti-dispersion agents and pharmaceutically acceptable excipients. The pharmacologically active detergent compositions are useful for treating localized accumulations of fat including, for example, lower eyelid fat herniation, lipodystrophy and fat deposits associated with cellulite and do not require surgical procedures such as liposuction.

    Patent expiration dates:

    • February 8, 2025
      ✓ 
      Patent use: METHOD FOR REDUCTION OF SUBMENTAL FAT
  • Synthetic bile acid compositions and methods
    Patent 8,883,770
    Issued: November 11, 2014
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

    Patent expiration dates:

    • February 21, 2028
      ✓ 
      Drug product
  • Synthetic bile acid compositions and methods
    Patent 9,522,155
    Issued: December 20, 2016
    Assignee(s): KYTHERA BIOPHARMACEUTICALS, INC.

    Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

    Patent expiration dates:

    • February 21, 2028
      ✓ 
      Patent use: IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING
      ✓ 
      Drug product
  • Synthetic bile acid compositions and methods
    Patent 9,636,349
    Issued: May 2, 2017
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

    Patent expiration dates:

    • February 21, 2028
      ✓ 
      Patent use: IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING
  • Synthetic bile acid compositions and methods
    Patent 9,949,986
    Issued: April 24, 2018
    Assignee(s): Kythera Biopharmaceuticals, Inc.

    Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

    Patent expiration dates:

    • February 21, 2028
      ✓ 
      Patent use: IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING

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.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

Further information

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