Last Updated: October 1, 2026

Omaveloxolone - Generic Drug Details

Name: omaveloxolone Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 Biogen Us and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for omaveloxolone

International Patents:	99
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	18
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^: ⤷ Start Trial* 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	PHASE3
Biogen	PHASE1
Biogen	Phase 1

See all omaveloxolone clinical trials

Pharmacology for omaveloxolone

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

Anatomical Therapeutic Chemical (ATC) Classes for omaveloxolone

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	11,919,838	⤷ Start Trial				⤷ Start Trial
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	8,993,640	⤷ Start Trial	Y	Y		⤷ Start Trial
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start 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 omaveloxolone

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Country	Patent Number	Title	Estimated Expiration
Australia	2009237579		⤷ Start Trial
Brazil	PI0911457		⤷ Start Trial
Canada	2721838		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for omaveloxolone

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2841445	PA2024511	Lithuania	⤷ Start Trial	PRODUCT NAME: OMAVELOKSOLONAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1786 20240209
2841445	122024000017	Germany	⤷ Start Trial	PRODUCT NAME: OMAVELOXOLON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1786 20240209
2841445	2490011-0	Sweden	⤷ Start Trial	PRODUCT NAME: OMAVELOXOLONE OR A PHARMACEUTICALLY ACCEPTBLE SALT THEREOF; REG. NO/DATE: EU/1/23/1786 20240212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.