Generic Kybella Availability
Last updated on Sep 11, 2024.
Kybella is a brand name of deoxycholic acid, approved by the FDA in the following formulation(s):
KYBELLA (deoxycholic acid - solution;subcutaneous)
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
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Manufacturer: WILSHIRE PHARMS INC
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.
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Formulations of deoxycholic acid and salts thereof
Patent 10,500,214
Issued: December 10, 2019
Inventor(s): Hodge Robert Emil & Webster Jeffrey Douglas
Assignee(s): ALLERGAN SALES, LLCThe 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✓
- March 2, 2030
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Patent 7,622,130
Patent expiration dates:
- December 10, 2027✓
- December 10, 2027
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Patent 7,754,230
Patent expiration dates:
- December 10, 2027✓
- December 10, 2027
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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✓
- March 2, 2030
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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✓
- May 16, 2028
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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.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✓
- August 3, 2025
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Formulations of deoxycholic acid and salts thereof
Patent 8,367,649
Issued: February 5, 2013
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✓
- March 2, 2030
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Synthetic bile acid compositions and methods
Patent 8,461,140
Issued: June 11, 2013
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:
- February 21, 2028✓
- February 21, 2028
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Synthetic bile acid compositions and methods
Patent 8,546,367
Issued: October 1, 2013
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:
- February 21, 2028✓✓
- February 21, 2028
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Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits
Patent 8,653,058
Issued: February 18, 2014
Inventor(s): Hodge Robert Emil & Webster Jeffrey Douglas & Moriarty Robert M.
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✓
- March 2, 2030
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Methods and related compositions for reduction of fat and skin tightening
Patent 8,846,066
Issued: September 30, 2014
Inventor(s): Kolodney Michael S. & Rotunda Adam M.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✓
- February 8, 2025
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Synthetic bile acid compositions and methods
Patent 8,883,770
Issued: November 11, 2014
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:
- February 21, 2028✓
- February 21, 2028
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Synthetic bile acid compositions and methods
Patent 9,522,155
Issued: December 20, 2016
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:
- February 21, 2028✓✓
- February 21, 2028
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Synthetic bile acid compositions and methods
Patent 9,636,349
Issued: May 2, 2017
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:
- February 21, 2028✓
- February 21, 2028
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Synthetic bile acid compositions and methods
Patent 9,949,986
Issued: April 24, 2018
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:
- February 21, 2028✓
- February 21, 2028
More about Kybella (deoxycholic acid)
- Check interactions
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- Reviews (10)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous uncategorized agents
- En español
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Glossary
Term | Definition |
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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.