Odevixibat Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as IPSEN. It is marketed under 1 brand name, including BYLVAY. Available in 4 different strengths, such as 0.2MG, 0.4MG, 1.2MG and others, and administered through 2 routes including CAPSULE, PELLETS;ORAL, 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":"45204","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"540d7b5f0c734e1db559","publication_number":"US10011633B2","cleaned_patent_number":"10011633","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-08","publication_date":"2018-07-03","legal_status":"Patented case"} US10011633B2 03 Jul, 2018 Patented case 08 Nov, 2031
{"application_id":"45205","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"540d7b5f0c734e1db559","publication_number":"US10093697B2","cleaned_patent_number":"10093697","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-08","publication_date":"2018-10-09","legal_status":"Granted"} US10093697B2 09 Oct, 2018 Granted 08 Nov, 2031
{"application_id":"45146","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"540d7b5f0c734e1db559","publication_number":"US10487111B2","cleaned_patent_number":"10487111","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-08","publication_date":"2019-11-26","legal_status":"Granted"} US10487111B2 26 Nov, 2019 Granted 08 Nov, 2031
{"application_id":"45207","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"540d7b5f0c734e1db559","publication_number":"US10981952B2","cleaned_patent_number":"10981952","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-08","publication_date":"2021-04-20","legal_status":"Granted"} US10981952B2 20 Apr, 2021 Granted 08 Nov, 2031
{"application_id":"45211","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"540d7b5f0c734e1db559","publication_number":"US11732006B2","cleaned_patent_number":"11732006","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-08","publication_date":"2023-08-22","legal_status":"Granted"} US11732006B2 22 Aug, 2023 Granted 08 Nov, 2031
{"application_id":"112424","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"540d7b5f0c734e1db559","publication_number":"US20230109432A1","cleaned_patent_number":"12187812","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-08","publication_date":"2025-01-07","legal_status":"Granted"} US12187812B2 07 Jan, 2025 Granted 08 Nov, 2031
{"application_id":"45202","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"540d7b5f0c734e1db559","publication_number":"US9694018B2","cleaned_patent_number":"9694018","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-08","publication_date":"2017-07-04","legal_status":"Patented case"} US9694018B2 04 Jul, 2017 Patented case 08 Nov, 2031
{"application_id":"114175","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"51a9c16b7b564765b8ad","publication_number":"US20220281832A1","cleaned_patent_number":"12091394","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-20","publication_date":"2022-09-08","legal_status":"Pending"} US12091394B2 Molecular 08 Sep, 2022 Pending 20 Jun, 2039
{"application_id":"119096","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"51a9c16b7b564765b8ad","publication_number":"US11801226B2","cleaned_patent_number":"11801226","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-20","publication_date":"2023-10-31","legal_status":"Granted"} US11801226B2 Formulation 31 Oct, 2023 Granted 20 Jun, 2039
{"application_id":"45252","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"51a9c16b7b564765b8ad","publication_number":"US10975046B2","cleaned_patent_number":"10975046","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-20","publication_date":"2021-04-13","legal_status":"Granted"} US10975046B2 Molecular 13 Apr, 2021 Granted 20 Jun, 2039
{"application_id":"45290","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"51a9c16b7b564765b8ad","publication_number":"US11802115B2","cleaned_patent_number":"11802115","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-20","publication_date":"2023-10-31","legal_status":"Granted"} US11802115B2 Formulation 31 Oct, 2023 Granted 20 Jun, 2039
{"application_id":"45288","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"51a9c16b7b564765b8ad","publication_number":"US11365182B2","cleaned_patent_number":"11365182","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-20","publication_date":"2022-06-21","legal_status":"Granted"} US11365182B2 21 Jun, 2022 Granted 20 Jun, 2039
{"application_id":"111611","ingredient":"ODEVIXIBAT","trade_name":"BYLVAY","family_id":"a89dc31513eb4ca293ac","publication_number":"US11583539B2","cleaned_patent_number":"11583539","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-11-12","publication_date":"2023-02-21","legal_status":"Granted"} US11583539B2 21 Feb, 2023 Granted 12 Nov, 2041

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.

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