Generic Skyclarys Availability
Last updated on May 7, 2025.
Skyclarys is a brand name of omaveloxolone, approved by the FDA in the following formulation(s):
SKYCLARYS (omaveloxolone - capsule;oral)
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Manufacturer: BIOGEN US
Approval date: February 28, 2023
Strength(s): 50MG [RLD]
Is there a generic version of Skyclarys available?
No. There is currently no therapeutically equivalent version of Skyclarys available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Skyclarys. 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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Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at c-17
Patent 11,091,430
Issued: August 17, 2021
Inventor(s): Anderson Eric & Jiang Xin & Visnick Melean
Assignee(s): REATA PHARMACEUTICALS, INC.This invention provides, but is not limited to, novel oleanolic acid derivatives having the formula:
Patent expiration dates:
- April 20, 2029✓
- April 20, 2029
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Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Patent 11,919,838
Issued: March 5, 2024
Inventor(s): Anderson; Eric et al.
Assignee(s): REATA PHARMACEUTICALS HOLDINGS, LLC (Plano, TX)This invention provides, but is not limited to, novel oleanolic acid derivatives having the formula: ##STR00001##
wherein the variables are defined herein. Also provided are pharmaceutical compositions, kits and articles of manufacture comprising such compounds, methods and intermediates useful for making the compounds, and methods of using the compounds and compositions.Patent expiration dates:
- April 20, 2029✓
- April 20, 2029✓
- April 20, 2029
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Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Patent 8,124,799
Issued: February 28, 2012
Inventor(s): Anderson Eric & Jiang Xin & Visnick Melean
Assignee(s): Reata Pharmaceuticals, Inc.This invention provides, but is not limited to, novel oleanolic acid derivatives having the formula:
Patent expiration dates:
- December 3, 2029✓
- December 3, 2029
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Antioxidant inflammation modulators: oleanolic acid derivatives with amino acid and other modifications at C-17
Patent 8,440,854
Issued: May 14, 2013
Inventor(s): Anderson Eric & Jiang Xin & Visnick Melean
Assignee(s): Reata Pharmaceuticals, Inc.This invention provides, but is not limited to, novel oleanolic acid derivatives having the formula:
Patent expiration dates:
- April 20, 2029✓
- April 20, 2029
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2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof
Patent 8,993,640
Issued: March 31, 2015
Inventor(s): Anderson Eric & Liu Xiaofeng & Decker Andrea
Assignee(s): Reata Pharmaceuticals, Inc.The present invention relates generally to the compound:
Patent expiration dates:
- April 24, 2033✓✓
- April 24, 2033
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Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Patent 9,670,147
Issued: June 6, 2017
Inventor(s): Anderson Eric & Jiang Xin & Visnick Melean
Assignee(s): REATA PHARMACEUTICALS, INC.This invention provides, but is not limited to, novel oleanolic acid derivatives having the formula:
Patent expiration dates:
- April 20, 2029✓
- April 20, 2029
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2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof
Patent 9,701,709
Issued: July 11, 2017
Inventor(s): Anderson Eric & Liu Xiaofeng & Decker Andrea
Assignee(s): REATA PHARMACEUTICALS, INC.The present invention relates generally to the compound:
Patent expiration dates:
- April 24, 2033✓✓
- April 24, 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:
- December 20, 2027 - INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
- February 28, 2028 - NEW CHEMICAL ENTITY
- February 28, 2030 - TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER
More about Skyclarys (omaveloxolone)
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- Drug class: miscellaneous central nervous system 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
