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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 six 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

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Summary for SKYCLARYS

International Patents:	88
US Patents:	6
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

Drug patent expirations by year for SKYCLARYS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SKYCLARYS

Generic Entry Date for SKYCLARYS^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER NDA: 216718 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 six 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

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

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Glossary

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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				⤷ 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	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		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.

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1121586		⤷ Try a Trial
Poland	2841445		⤷ Try a Trial
Malaysia	172750	2,2-DIFLUOROPROPIONAMIDE DERIVATIVES OF BARDOXOLONE METHYL, POLYMORPHIC FORMS AND METHODS OF USE THEREOF	⤷ Try a Trial
Eurasian Patent Organization	201001555	АНТИОКСИДАТИВНЫЕ МОДУЛЯТОРЫ ВОСПАЛЕНИЯ: ПРОИЗВОДНЫЕ ОЛЕАНОЛЕВОЙ КИСЛОТЫ С АМИНОВЫМИ И ДРУГИМИ МОДИФИКАЦИЯМИ НА С-17	⤷ Try a Trial
Portugal	3444261		⤷ Try a Trial
European Patent Office	3444261	DÉRIVÉ 2,2-DIFLUOROPROPIONAMIDE DE MÉTHYLE DE BARDOXOLONE, COMPOSITIONS PHARMACEUTIQUES LE CONTENANTS ET SES FORMES POLYMORPHES POUR LE TRAITEMENT DE CERTAINES MALADIES (2,2-DIFLUOROPROPIONAMIDE DERIVATIVE OF BARDOXOLONE METHYL, PHARMACEUTICAL COMPOSITIONS AND POLYMORPHS THEREOF FOR USE IN TREATING CERTAIN CONDITIONS)	⤷ Try a Trial
Taiwan	I453023		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration