Stem definition | Drug id | CAS RN |
---|---|---|
ileal bile acid transporter (IBAT) inhibitors, bile acid reabsorption inhibitors | 5468 | 501692-44-0 |
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Date | Agency | Company | Orphan |
---|---|---|---|
July 16, 2021 | EMA | ALBIREO | |
July 20, 2021 | FDA | ALBIREO PHARMA INC |
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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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Pruritus in progressive familial intrahepatic cholestasis (PFIC) | indication | 74162007 | DOID:0070221 |
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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) |
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) |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Ileal sodium/bile acid cotransporter | Transporter | INHIBITOR | IC50 | 9.89 | DRUG LABEL | DRUG LABEL |
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 |
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 |