odevixibat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
ileal bile acid transporter (IBAT) inhibitors, bile acid reabsorption inhibitors	5468	501692-44-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: odevixibat bylvay A4250 AZD8294 AR-H064974	Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is a common symptom in patients with PFIC and the pathophysiology of pruritus in patients with PFIC is not completely understood. Although the complete mechanism by which odevixibat improves pruritus in PFIC patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids. Molecular weight: 740.93 Formula: C37H48N4O8S2 CLOGP: 7.75 LIPINSKI: 3 HAC: 12 HDO: 5 TPSA: 174.37 ALOGS: -5.81 ROTB: 17 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

odevixibat
bylvay
A4250
AZD8294
AR-H064974

Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is a common symptom in patients with PFIC and the pathophysiology of pruritus in patients with PFIC is not completely understood. Although the complete mechanism by which odevixibat improves pruritus in PFIC patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids.

Molecular weight: 740.93
Formula: C37H48N4O8S2
CLOGP: 7.75
LIPINSKI: 3
HAC: 12
HDO: 5
TPSA: 174.37
ALOGS: -5.81
ROTB: 17

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 16, 2021	EMA	ALBIREO
July 20, 2021	FDA	ALBIREO PHARMA INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A05AX05	ALIMENTARY TRACT AND METABOLISM BILE AND LIVER THERAPY BILE THERAPY Other drugs for bile therapy
FDA EPC	N0000193957	Ileal Bile Acid Transporter Inhibitor
FDA MoA	N0000193958	Ileal Bile Acid Transporter Inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Pruritus in progressive familial intrahepatic cholestasis (PFIC)	indication	74162007	DOID:0070221

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10011633	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10093697	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10487111	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	10981952	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	9694018	Nov. 8, 2031	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11365182	June 20, 2039	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11365182	June 20, 2039	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11583539	Nov. 12, 2041	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11583539	Nov. 12, 2041	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	11583539	Nov. 12, 2041	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	11583539	Nov. 12, 2041	METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	June 13, 2026	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	June 13, 2026	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	June 13, 2026	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	June 13, 2026	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	July 20, 2026	NEW CHEMICAL ENTITY
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	July 20, 2026	NEW CHEMICAL ENTITY
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	July 20, 2026	NEW CHEMICAL ENTITY
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	July 20, 2026	NEW CHEMICAL ENTITY
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	July 20, 2028	TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	July 20, 2028	TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	July 20, 2028	TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	July 20, 2028	TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
0.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	June 13, 2030	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
0.4MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	June 13, 2030	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
0.6MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE, PELLETS	ORAL	June 13, 2030	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
1.2MG	BYLVAY	ALBIREO	N215498	July 20, 2021	RX	CAPSULE	ORAL	June 13, 2030	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Ileal sodium/bile acid cotransporter	Transporter	Q12908	NTCP2_HUMAN	INHIBITOR	IC50	9.89		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
2W150K0UUC	UNII
C5238052	UMLSCUI
CHEMBL4297588	ChEMBL_ID
D11716	KEGG_DRUG
10153627	PUBCHEM_CID
DB16261	DRUGBANK_ID
10706	INN_ID
11194	IUPHAR_LIGAND_ID
018812	NDDF
4040726	VANDF
1179270000	SNOMEDCT_US
1179274009	SNOMEDCT_US
2563966	RXNORM
348576	MMSL
39722	MMSL
d09775	MMSL
C000713258	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-020	CAPSULE, COATED PELLETS	200 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-020	CAPSULE, COATED PELLETS	200 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-020	CAPSULE, COATED PELLETS	200 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-040	CAPSULE, COATED PELLETS	400 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-040	CAPSULE, COATED PELLETS	400 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-040	CAPSULE, COATED PELLETS	400 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-060	CAPSULE, COATED PELLETS	600 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-060	CAPSULE, COATED PELLETS	600 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-060	CAPSULE, COATED PELLETS	600 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-120	CAPSULE, COATED PELLETS	1200 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-120	CAPSULE, COATED PELLETS	1200 ug	ORAL	NDA	30 sections
BYLVAY	HUMAN PRESCRIPTION DRUG LABEL	1	74528-120	CAPSULE, COATED PELLETS	1200 ug	ORAL	NDA	30 sections