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Generic Ocaliva Availability

Last updated on Jan 11, 2023.

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

OCALIVA (obeticholic acid - tablet;oral)

  • Manufacturer: INTERCEPT PHARMS INC
    Approval date: May 27, 2016
    Strength(s): 5MG [RLD], 10MG [RLD]

Has a generic version of Ocaliva been approved?

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

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

  • Preparation and uses of obeticholic acid
    Patent 10,047,117
    Issued: August 14, 2018
    Assignee(s): Intercept Pharmaceuticals, Inc.

    The present invention relates to obeticholic acid: or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.

    Patent expiration dates:

    • September 6, 2033
      ✓ 
      Patent use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
  • Compositions of obeticholic acid and methods of use
    Patent 10,052,337
    Issued: August 21, 2018
    Assignee(s): Intercept Pharmaceuticals, Inc.

    The disclosure relates to obeticholic acid formulations with improved stability, dissolution, and/or solubility, methods of preparing the same for use and methods of treating various diseases and conditions.

    Patent expiration dates:

    • April 26, 2036
      ✓ 
      Drug product
  • Preparation and uses of obeticholic acid
    Patent 10,174,073
    Issued: January 8, 2019
    Assignee(s): Intercept Pharmaceuticals, Inc.

    The present invention relates to obeticholic acid: or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.

    Patent expiration dates:

    • June 17, 2033
      ✓ 
      Drug substance
  • Patent 10,751,349

    Patent expiration dates:

    • April 26, 2036
      ✓ 
      Drug product
  • Patent 10,758,549

    Patent expiration dates:

    • April 26, 2036
      ✓ 
      Patent use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA
  • Steroids as agonists for FXR
    Patent 7,138,390
    Issued: November 21, 2006
    Inventor(s): Pellicciari; Roberto
    Assignee(s): Intercept Pharmaceuticals

    The invention relates to compounds of formula (I): wherein R is ethyl and pharmaceutically acceptable salts, solvates or amino acid conjugates thereof. The compounds of formula (I) are useful as FXR agonists.

    Patent expiration dates:

    • November 16, 2022
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Steroids as agonists for FXR
    Patent 8,058,267
    Issued: November 15, 2011
    Inventor(s): Pellicciari; Roberto
    Assignee(s): Intercept Pharmaceuticals, Inc.

    The invention relates to compounds of formula (I): wherein R is ethyl and pharmaceutically acceptable salts, solvates or amino acid conjugates thereof. The compounds of formula (I) are useful as FXR agonists.

    Patent expiration dates:

    • February 21, 2022
      ✓ 
      Patent use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
  • Steroids as agonists for FXR
    Patent 8,377,916
    Issued: February 19, 2013
    Assignee(s): Intercept Pharmaceuticals, Inc.

    The invention relates to compounds of formula (I): wherein R is ethyl, propyl or allyl, and pharmaceutically acceptable salts, solvates or amino acid conjugates thereof. The compounds of formula (I) are useful as FXR agonists.

    Patent expiration dates:

    • February 21, 2022
      ✓ 
      Patent use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
  • Preparation and uses of obeticholic acid
    Patent 9,238,673
    Issued: January 19, 2016
    Assignee(s): Intercept Pharmaceuticals, Inc.

    The present invention relates to obeticholic acid: or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.

    Patent expiration dates:

    • June 17, 2033
      ✓ 
      Drug product
  • Patent RE48286

    Patent expiration dates:

    • February 21, 2027
      ✓ 
      Drug substance
      ✓ 
      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:

    • May 27, 2023 - TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA

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.

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