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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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

Anatomical Therapeutic Chemical (ATC) Classes for ODEVIXIBAT

A05AX	Other drugs for bile therapy
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ODEVIXIBAT

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Glossary

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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				⤷ Sign Up
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	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				⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	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

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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

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Country	Patent Number	Title	Estimated Expiration
Malaysia	163275	IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES	⤷ Sign Up
Croatia	P20181185		⤷ Sign Up
Nicaragua	202000104	FORMULACIÓN FARMACÉUTICA DE ODEVIXIBAT	⤷ Sign Up
Colombia	2020015772	Formulación farmacéutica de odevixibat	⤷ Sign Up
Colombia	2020015781	Modificaciones de cristales de odexibat	⤷ Sign Up
Croatia	P20160993		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ODEVIXIBAT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3400944	LUC00242	Luxembourg	⤷ Sign Up	PRODUCT NAME: ODEVIXIBAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BYLVAY); AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719
3400944	2190043-6	Sweden	⤷ Sign Up	PRODUCT NAME: ODEVIXIBAT; REG. NO/DATE: EU/1/21/1556 20210719
3400944	48/2021	Austria	⤷ Sign Up	PRODUCT NAME: ODEVIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1566 (MITTEILUNG) 20210719
3400944	2021C/554	Belgium	⤷ Sign Up	PRODUCT NAME: ODEVIXIBAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1566 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
3400944	PA2021012	Lithuania	⤷ Sign Up	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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