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 | 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 | ⤷ 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 | 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 |
|---|---|---|---|
| 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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