Omaveloxolone - Generic Drug Details

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What are the generic sources for omaveloxolone and what is the scope of freedom to operate?

Omaveloxolone is the generic ingredient in one branded drug marketed by Reata Pharms and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omaveloxolone has one hundred and sixteen patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for omaveloxolone

International Patents:	116
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	13
Patent Applications:	148
What excipients (inactive ingredients) are in omaveloxolone?	omaveloxolone excipients list
DailyMed Link:	omaveloxolone at DailyMed

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

Generic Entry Date for omaveloxolone^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER 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 omaveloxolone

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

Sponsor	Phase
Biogen	Phase 1
Reata, a wholly owned subsidiary of Biogen	Phase 1
altasciences	Phase 1

See all omaveloxolone clinical trials

Pharmacology for omaveloxolone

Mechanism of Action	Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for omaveloxolone

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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	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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 omaveloxolone

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1207086	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-)	⤷ Subscribe
Portugal	2352728		⤷ Subscribe
Poland	2276493		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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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.

Summary for omaveloxolone

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for omaveloxolone

Recent Clinical Trials for omaveloxolone

Pharmacology for omaveloxolone

Make Better Decisions: Try a trial or see plans & pricing

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