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
Sponsor | Phase |
---|---|
Biogen | Phase 1 |
Reata, a wholly owned subsidiary of Biogen | Phase 1 |
Celerion | Phase 1 |
Pharmacology for omaveloxolone
Mechanism of Action | Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers |
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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