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 eighty-eight patent family members in thirty-five countries.
The generic ingredient in SKYCLARYS is omaveloxolone. One supplier is 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
Summary for SKYCLARYS
International Patents: | 88 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
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
Generic Entry Date for SKYCLARYS*:
Constraining patent/regulatory exclusivity:
TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER NDA:
Dosage:
CAPSULE;ORAL |
*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.
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING FRIEDRICH'S ATAXIA BY ACTIVATING THE NRF2 PATHWAY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Antioxidant inflammation modulators: oleanolic acid derivatives with amino acid and other modifications at C-17
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting SKYCLARYS
TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Reata Pharms | SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718-001 | Feb 28, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 |
---|---|---|---|
Argentina | 092823 | DERIVADOS DE 2,2-DIFLUOROPROPIONAMIDA DE METILO DE BARDOXOLONA, FORMAS POLIMORFICAS Y SUS METODOS DE USO | ⤷ Try a Trial |
Malaysia | 172750 | 2,2-DIFLUOROPROPIONAMIDE DERIVATIVES OF BARDOXOLONE METHYL, POLYMORPHIC FORMS AND METHODS OF USE THEREOF | ⤷ Try a Trial |
Slovenia | 2841445 | ⤷ Try a Trial | |
Hong Kong | 1207085 | 甲基巴多索隆的 -二氟丙酰胺衍生物、其多晶型物及使用方法 (2,2-DIFLUOROPROPIONAMIDE DERIVATIVES OF BARDOXOLONE METHYL, POLYMORPHIC FORMS AND METHODS OF USE THEREOF 22-) | ⤷ Try a Trial |
New Zealand | 588710 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 | ⤷ Try a Trial |
Serbia | 61544 | DERIVAT 2,2-DIFLUOROPROPIONAMIDA METIL BARDOKSOLONA, NJEGOVE FARMACEUTSKE SUPSTANCE I POLIMORFI ZA UPOTREBU ZA LEČENJE IZVESNIH STANJA (2,2-DIFLUOROPROPIONAMIDE DERIVATIVE OF BARDOXOLONE METHYL, PHARMACEUTICAL COMPOSITIONS AND POLYMORPHS THEREOF FOR USE IN TREATING CERTAIN CONDITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |