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Last Updated: June 21, 2024

ODEVIXIBAT - Generic Drug Details


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What are the generic drug sources for odevixibat and what is the scope of freedom to operate?

Odevixibat is the generic ingredient in one branded drug marketed by Ipsen and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Odevixibat has one hundred and eleven patent family members in forty countries.

Two suppliers are listed for this compound.

Summary for ODEVIXIBAT
International Patents:111
US Patents:11
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 20
Clinical Trials: 4
Patent Applications: 174
What excipients (inactive ingredients) are in ODEVIXIBAT?ODEVIXIBAT excipients list
DailyMed Link:ODEVIXIBAT at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ODEVIXIBAT
Generic Entry Date for ODEVIXIBAT*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, PELLETS;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 ODEVIXIBAT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AlbireoPhase 3

See all ODEVIXIBAT clinical trials

Pharmacology for ODEVIXIBAT

US Patents and Regulatory Information for ODEVIXIBAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-001 Jul 20, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE;ORAL 215498-004 Jul 20, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE;ORAL 215498-004 Jul 20, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-003 Jul 20, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-003 Jul 20, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-001 Jul 20, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ODEVIXIBAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipsen BYLVAY odevixibat CAPSULE;ORAL 215498-004 Jul 20, 2021 ⤷  Sign Up ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-001 Jul 20, 2021 ⤷  Sign Up ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE;ORAL 215498-002 Jul 20, 2021 ⤷  Sign Up ⤷  Sign Up
Ipsen BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-003 Jul 20, 2021 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ODEVIXIBAT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Albireo Bylvay odevixibat EMEA/H/C/004691
Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).
Authorised no no yes 2021-07-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ODEVIXIBAT

Country Patent Number Title Estimated Expiration
Canada 3100691 MODIFICATIONS CRISTALLINES D'ODEVIXIBAT (CRYSTAL MODIFICATIONS OF ODEVIXIBAT) ⤷  Sign Up
European Patent Office 3400944 INHIBITEURS IBAT POUR LE TRAITEMENT DE MALADIES DU FOIE (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES) ⤷  Sign Up
Canada 3196488 ODEVIXIBAT POUR LE TRAITEMENT DE LA CHOLESTASE INTRAHEPATIQUE FAMILIALE PROGRESSIVE (CIFP) (ODEVIXIBAT FOR TREATING PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)) ⤷  Sign Up
Colombia 2020015781 Modificaciones de cristales de odexibat ⤷  Sign Up
Colombia 2020015772 Formulación farmacéutica de odevixibat ⤷  Sign Up
China 116710100 用于治疗进行性家族性肝内胆汁淤积(PFIC)的奥德昔巴特 (Odxicabet for treatment of progressive familial intrahepatic cholestasis (PFIC)) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ODEVIXIBAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3400944 CR 2022 00001 Denmark ⤷  Sign Up PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719
3400944 C202130067 Spain ⤷  Sign Up PRODUCT NAME: ODEVIXIBAT; NATIONAL AUTHORISATION NUMBER: EU/1/21/1566; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1566; DATE OF FIRST AUTHORISATION IN EEA: 20210716
3400944 301157 Netherlands ⤷  Sign Up PRODUCT NAME: ODEVIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1566 20210719
3400944 PA2021012 Lithuania ⤷  Sign Up PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716
3400944 SPC/GB21/078 United Kingdom ⤷  Sign Up PRODUCT NAME: ODEVIXIBAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING ODEVIXIBAT SESQUIHYDRATE; REGISTERED: UK EU/1/21/1566(NI) 20210719; UK PLGB 36216/0001 20210719; UK PLGB 36216/0002 20210719
3400944 122021000075 Germany ⤷  Sign Up PRODUCT NAME: ODEVIXIBAT, EINSCHLIESSLICH PHARMAZEUTISCH VERTRAEGLICHER SALZE UND SOLVATE DAVON, INSBESONDERE ODEVIXIBAT-HYDRAT; REGISTRATION NO/DATE: EU/1/21/1566 20210716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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