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skyclarys Drug Patent Profile

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When do Skyclarys patents expire, 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

Drug patent expirations by year for skyclarys

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

Generic Entry Date for skyclarys^: ⤷ Sign Up* 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.

Recent Clinical Trials for skyclarys

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biogen	Phase 1

See all skyclarys clinical trials

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

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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	⤷ 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
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		Y		⤷ 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.

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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
South Korea	20150003875	2,2-DIFLUOROPROPIONAMIDE DERIVATIVES OF BARDOXOLONE METHYL, POLYMORPHIC FORMS AND METHODS OF USE THEREOF	⤷ Sign Up
China	104177468	ANTIOXIDANT INFLAMMATION MODULATORS: OLEANOLIC ACID DERIVATIVES WITH AMINO AND OTHER MODIFICATIONS AT C-17	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration