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Last Updated: January 27, 2023

Odevixibat - Generic Drug Details


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What are the generic drug sources for odevixibat and what is the scope of patent protection?

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

Odevixibat has one hundred and thirty-seven patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for odevixibat
International Patents:137
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 15
Clinical Trials: 4
Patent Applications: 147
What excipients (inactive ingredients) are in odevixibat?odevixibat excipients list
DailyMed Link:odevixibat at DailyMed
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
Albireo BYLVAY odevixibat CAPSULE;ORAL 215498-002 Jul 20, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Albireo BYLVAY odevixibat CAPSULE;ORAL 215498-004 Jul 20, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Albireo BYLVAY odevixibat CAPSULE;ORAL 215498-002 Jul 20, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Albireo BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-001 Jul 20, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Albireo BYLVAY odevixibat CAPSULE;ORAL 215498-004 Jul 20, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Albireo BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-001 Jul 20, 2021 See Plans and Pricing See Plans and Pricing
Albireo BYLVAY odevixibat CAPSULE;ORAL 215498-002 Jul 20, 2021 See Plans and Pricing See Plans and Pricing
Albireo BYLVAY odevixibat CAPSULE;ORAL 215498-004 Jul 20, 2021 See Plans and Pricing See Plans and Pricing
Albireo BYLVAY odevixibat CAPSULE, PELLETS;ORAL 215498-003 Jul 20, 2021 See Plans and Pricing See Plans and Pricing
>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
China 1582151 See Plans and Pricing
Hong Kong 1188730 用於治療肝臟疾病的 抑制劑 (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES IBAT) See Plans and Pricing
Jordan P20200299 صيغة صيدلانية لأوديفيكسيبات (PHARMACEUTICAL FORMULATION OF ODEVIXIBAT) See Plans and Pricing
Israel 279468 שינויי גביש של אודוויקסיבאט (Crystal modifications of odevixibat) See Plans and Pricing
Serbia 57778 INHIBITORI CREVNOG TRANSPORTERA ŽUČNE KISELINE (IBAT) ZA LEČENJE BOLESTI JETRE (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for odevixibat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3400944 122021000075 Germany See Plans and Pricing PRODUCT NAME: ODEVIXIBAT, EINSCHLIESSLICH PHARMAZEUTISCH VERTRAEGLICHER SALZE UND SOLVATE DAVON, INSBESONDERE ODEVIXIBAT-HYDRAT; REGISTRATION NO/DATE: EU/1/21/1566 20210716
3400944 LUC00242 Luxembourg See Plans and Pricing PRODUCT NAME: ODEVIXIBAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BYLVAY); AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719
3400944 CA 2022 00001 Denmark See Plans and Pricing PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719
3400944 48/2021 Austria See Plans and Pricing PRODUCT NAME: ODEVIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1566 (MITTEILUNG) 20210719
3400944 PA2021012 Lithuania See Plans and Pricing PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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