Generic Ocaliva Availability
Ocaliva is a brand name of obeticholic acid, approved by the FDA in the following formulation(s):
OCALIVA (obeticholic acid - tablet;oral)
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Manufacturer: INTERCEPT PHARMS INC
Approval date: May 27, 2016
Strength(s): 5MG, 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: About generic drugs.
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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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✓✓
- November 16, 2022
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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✓
- February 21, 2022
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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✓
- February 21, 2022
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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✓
- June 17, 2033
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, 2021 - NEW CHEMICAL ENTITY
- May 27, 2023 - ORPHAN DRUG EXCLUSIVITY
More about Ocaliva (obeticholic acid)
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- Drug class: miscellaneous GI agents
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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. |
