Generic Ocaliva Availability
Last updated on Jun 11, 2025.
Ocaliva is a brand name of obeticholic acid, approved by the FDA in the following formulation(s):
OCALIVA (obeticholic acid - tablet;oral)
Is there a generic version of Ocaliva available?
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.
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Preparation and uses of obeticholic acid
Patent 10,047,117
Issued: August 14, 2018
Inventor(s): Steiner André & Waenerlund Poulsen Heidi & Jolibois Emilie & Rewolinski Melissa & Gross Ralf & Sharp Emma & Dubas-Fisher Fiona & Eberlin Alex
Assignee(s): Intercept Pharmaceuticals, Inc.The present invention relates to obeticholic acid:
Patent expiration dates:
- September 6, 2033✓
- September 6, 2033
-
Compositions of obeticholic acid and methods of use
Patent 10,052,337
Issued: August 21, 2018
Inventor(s): Lancaster Richard Gail & Olmstead Kay K. & Kagihiro Masashi & Matono Mitsuhiro & Taoka Ikuko & Pruzanski Mark & Shapiro David & Hooshmand-Rad Roya & Pencek Richard & Sciacca Cathi & Eliot Lise & Edwards Jeffrey & MacConell Leigh A. & Marmon Tonya K.
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✓
- April 26, 2036
-
Preparation and uses of obeticholic acid
Patent 10,174,073
Issued: January 8, 2019
Inventor(s): Steiner André & Waenerlund Poulsen Heidi & Jolibois Emilie & Rewolinski Melissa & Gross Ralf & Sharp Emma & Dubas-Fisher Fiona & Eberlin Alex
Assignee(s): Intercept Pharmaceuticals, Inc.The present invention relates to obeticholic acid:
Patent expiration dates:
- June 17, 2033✓
- June 17, 2033
-
Compositions of obeticholic acid and methods of use
Patent 10,751,349
Issued: August 25, 2020
Inventor(s): Lancaster Richard Gail & Olmstead Kay K. & Kagihiro Masashi & Matono Mitsuhiro & Taoka Ikuko & Pruzanski Mark & Shapiro David & Hooshmand-Rad Roya & Pencek Richard & Sciacca Cathi & Eliot Lise & Edwards Jeffrey & MacConell Leigh A. & Marmon Tonya K.
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✓
- April 26, 2036
-
Compositions of obeticholic acid and methods of use
Patent 10,758,549
Issued: September 1, 2020
Inventor(s): Lancaster Richard Gail & Olmstead Kay K. & Kagihiro Masashi & Matono Mitsuhiro & Taoka Ikuko & Pruzanski Mark & Shapiro David & Hooshmand-Rad Roya & Pencek Richard & Sciacca Cathi & Eliot Lise & Edwards Jeffrey & MacConell Leigh A. & Marmon Tonya K.
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✓
- April 26, 2036
-
Preparation and uses of obeticholic acid
Patent 9,238,673
Issued: January 19, 2016
Inventor(s): Steiner André & Waenerlund Poulsen Heidi & Jolibois Emilie & Rewolinski Melissa & Gross Ralf & Sharp Emma & Dubas-Fisher Fiona & Eberlin Alex
Assignee(s): Intercept Pharmaceuticals, Inc.The present invention relates to obeticholic acid:
Patent expiration dates:
- June 17, 2033✓
- June 17, 2033
-
Steroids as agonists for FXR
Patent RE48286
Issued: October 27, 2020
Inventor(s): Pellicciari Roberto
Assignee(s): Intercept Pharmaceuticals, Inc.The invention relates to compounds of formula (I):
Patent expiration dates:
- February 21, 2027✓✓
- February 21, 2027
More about Ocaliva (obeticholic acid)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (3)
- Drug images
- Latest FDA alerts (4)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous GI agents
- En español
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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.
