Odevixibat - Generic Drug Details

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

Sponsor	Phase
Albireo	Phase 3

See all odevixibat clinical trials

Pharmacology for odevixibat

Drug Class	Ileal Bile Acid Transporter Inhibitor
Mechanism of Action	Ileal Bile Acid Transporter Inhibitors

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
Albireo	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes				Y
Albireo	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No
Albireo	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No
Albireo	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes

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
Albireo	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021
Albireo	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021
Albireo	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021

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

International Patents for odevixibat

Country	Patent Number	Title	Estimated Expiration
China	1582151
Hong Kong	1188730	用於治療肝臟疾病的 抑制劑 (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES IBAT)
Jordan	P20200299	صيغة صيدلانية لأوديفيكسيبات (PHARMACEUTICAL FORMULATION OF ODEVIXIBAT)
Israel	279468	שינויי גביש של אודוויקסיבאט (Crystal modifications of odevixibat)
Serbia	57778	INHIBITORI CREVNOG TRANSPORTERA ŽUČNE KISELINE (IBAT) ZA LEČENJE BOLESTI JETRE (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES)

Supplementary Protection Certificates for odevixibat

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