SKYCLARYS Drug Patent Profile
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Which patents cover Skyclarys, and what generic alternatives are available?
Skyclarys is a drug marketed by Reata Pharms and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and sixteen patent family members in thirty-seven countries.
The generic ingredient in SKYCLARYS is omaveloxolone. Two suppliers are listed for this compound. Additional details are available on the omaveloxolone profile page.
DrugPatentWatch® Generic Entry Outlook for Skyclarys
Skyclarys will be eligible for patent challenges on February 28, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 28, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for SKYCLARYS
| International Patents: | 116 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 1 |
| Patent Applications: | 49 |
| Drug Prices: | Drug price information for SKYCLARYS |
| What excipients (inactive ingredients) are in SKYCLARYS? | SKYCLARYS excipients list |
| DailyMed Link: | SKYCLARYS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SKYCLARYS
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for SKYCLARYS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Biogen | Phase 1 |
Pharmacology for SKYCLARYS
| Mechanism of Action | Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers |
US Patents and Regulatory Information for SKYCLARYS
SKYCLARYS is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SKYCLARYS is ⤷ Sign Up.
This potential generic entry date is based on TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SKYCLARYS
Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at c-17
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING FRIEDRICH'S ATAXIA BY ACTIVATING THE NRF2 PATHWAY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING FRIEDRICH'S ATAXIA BY ACTIVATING THE NRF2 PATHWAY WHICH REDUCES OXIDATIVE STRESS
Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Antioxidant inflammation modulators: oleanolic acid derivatives with amino acid and other modifications at C-17
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting SKYCLARYS
TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER
Exclusivity Expiration: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SKYCLARYS
See the table below for patents covering SKYCLARYS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2634315 | ⤷ Sign Up | |
| Denmark | 2841445 | ⤷ Sign Up | |
| Canada | 2869783 | DERIVES 2,2-DIFLUOROPROPIONAMIDE DE BARDOXOLONE METHYLE, LEURS FORMES POLYMORPHES ET LEURS PROCEDES D'UTILISATION (2.2-DIFLUOROPROPIONAMIDE DERIVATIVES OF BARDOXOLONE METHYL, POLYMORPHIC FORMS AND METHODS OF USE THEREOF) | ⤷ Sign Up |
| Lithuania | 2276493 | ⤷ Sign Up | |
| Mexico | 2010011438 | ANTIOXIDANTES MODULADORES DE LA INFLAMACION: DERIVADOS DEL ACIDO OLEANÓLICO CON AMINO Y OTRAS MODIFICACIONES EN C-17. (ANTIOXIDANT INFLAMMATION MODULATORS: OLEANOLIC ACID DERIVATIVES WITH AMINO AND OTHER MODIFICATIONS AT C-17.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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