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Last Updated: December 10, 2024

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*:
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

SponsorPhase
BiogenPhase 1
Reata, a wholly owned subsidiary of BiogenPhase 1
CelerionPhase 1

See all omaveloxolone clinical trials

Pharmacology for omaveloxolone

US Patents and Regulatory Information for omaveloxolone

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 ⤷  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
>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

Country Patent Number Title Estimated Expiration
Israel 235275 נגזרות 2,2 דיפלאורופרופיונאמיד של מתיל בארדוקסולון, צורות פולימורפיות שלהן ושיטות לשימוש בהן (2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof) ⤷  Sign Up
Portugal 3444261 ⤷  Sign Up
Spain 2861393 ⤷  Sign Up
South Korea 102101774 ⤷  Sign Up
>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.