Omaveloxolone Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 1 pharmaceutical company such as BIOGEN US. It is marketed under 1 brand name, including SKYCLARYS. Available in 1 different strength, such as 50MG, and administered through 1 route including CAPSULE;ORAL.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength	Route of Administration	Companies	Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

	Patent Number	Publication Date	Legal Status	Patent Expiry Date
{"application_id":"111703","ingredient":"OMAVELOXOLONE","trade_name":"SKYCLARYS","family_id":"600835b91ed84ab8a063","publication_number":"US8440854B2","cleaned_patent_number":"8440854","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-20","publication_date":"2013-05-14","legal_status":"Granted"}	US8440854B2 Formulation	14 May, 2013	Granted	20 Apr, 2029
{"application_id":"111708","ingredient":"OMAVELOXOLONE","trade_name":"SKYCLARYS","family_id":"600835b91ed84ab8a063","publication_number":"US11919838B2","cleaned_patent_number":"11919838","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-20","publication_date":"2024-03-05","legal_status":"Granted"}	US11919838B2	05 Mar, 2024	Granted	20 Apr, 2029
{"application_id":"111707","ingredient":"OMAVELOXOLONE","trade_name":"SKYCLARYS","family_id":"600835b91ed84ab8a063","publication_number":"US11091430B2","cleaned_patent_number":"11091430","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-20","publication_date":"2021-08-17","legal_status":"Granted"}	US11091430B2	17 Aug, 2021	Granted	20 Apr, 2029
{"application_id":"111675","ingredient":"OMAVELOXOLONE","trade_name":"SKYCLARYS","family_id":"600835b91ed84ab8a063","publication_number":"US9670147B2","cleaned_patent_number":"9670147","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-20","publication_date":"2017-06-06","legal_status":"Granted"}	US9670147B2 Molecular	06 Jun, 2017	Granted	20 Apr, 2029
{"application_id":"111702","ingredient":"OMAVELOXOLONE","trade_name":"SKYCLARYS","family_id":"600835b91ed84ab8a063","publication_number":"US8124799B2","cleaned_patent_number":"8124799","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-03","publication_date":"2012-02-28","legal_status":"Granted"}	US8124799B2 Molecular	28 Feb, 2012	Granted	03 Dec, 2029
{"application_id":"111620","ingredient":"OMAVELOXOLONE","trade_name":"SKYCLARYS","family_id":"bd0f2074d7db4b9185b5","publication_number":"US8993640B2","cleaned_patent_number":"8993640","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-04-24","publication_date":"2015-03-31","legal_status":"Granted"}	US8993640B2 Molecular Formulation	31 Mar, 2015	Granted	24 Apr, 2033
{"application_id":"111666","ingredient":"OMAVELOXOLONE","trade_name":"SKYCLARYS","family_id":"bd0f2074d7db4b9185b5","publication_number":"US9701709B2","cleaned_patent_number":"9701709","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-04-24","publication_date":"2017-07-11","legal_status":"Granted"}	US9701709B2 Molecular Formulation	11 Jul, 2017	Granted	24 Apr, 2033

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID	Title	Status	Phase	Conditions	Start Date	Completion Date

API Suppliers/Manufacturer (Branded/Generic companies)

Manufacturing Locations

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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.