BYLVAY Drug Patent Profile
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When do Bylvay patents expire, and when can generic versions of Bylvay launch?
Bylvay is a drug marketed by Ipsen and is included in one NDA. There are eleven patents protecting this drug.
This drug has one hundred and ten patent family members in forty countries.
The generic ingredient in BYLVAY is odevixibat. Two suppliers are listed for this compound. Additional details are available on the odevixibat profile page.
DrugPatentWatch® Generic Entry Outlook for Bylvay
Bylvay will be eligible for patent challenges on July 20, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 20, 2039. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BYLVAY
International Patents: | 110 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 15 |
Drug Prices: | Drug price information for BYLVAY |
What excipients (inactive ingredients) are in BYLVAY? | BYLVAY excipients list |
DailyMed Link: | BYLVAY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BYLVAY
Generic Entry Date for BYLVAY*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Pharmacology for BYLVAY
Drug Class | Ileal Bile Acid Transporter Inhibitor |
Mechanism of Action | Ileal Bile Acid Transporter Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BYLVAY
US Patents and Regulatory Information for BYLVAY
BYLVAY is protected by thirty-two US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYLVAY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting BYLVAY
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Crystal modifications of odevixibat
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Crystal modifications of odevixibat
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Crystal modifications of odevixibat
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Crystal modifications of odevixibat
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Crystal modifications of odevixibat
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
IBAT inhibitors for the treatment of liver disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
IBAT inhibitors for the treatment of liver disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
IBAT inhibitors for the treatment of liver disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
FDA Regulatory Exclusivity protecting BYLVAY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Exclusivity Expiration: ⤷ Try a Trial
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 | 215498-003 | Jul 20, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-003 | Jul 20, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-001 | Jul 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-004 | Jul 20, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-004 | Jul 20, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-004 | Jul 20, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-002 | Jul 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 BYLVAY
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-001 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-003 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-004 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-002 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BYLVAY
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 BYLVAY
When does loss-of-exclusivity occur for BYLVAY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 19290337
Estimated Expiration: ⤷ Try a Trial
Patent: 19290338
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2020024461
Estimated Expiration: ⤷ Try a Trial
Patent: 2020024479
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 00687
Estimated Expiration: ⤷ Try a Trial
Patent: 00691
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 20003295
Estimated Expiration: ⤷ Try a Trial
Patent: 20003296
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2262130
Estimated Expiration: ⤷ Try a Trial
Patent: 2312893
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 20015772
Estimated Expiration: ⤷ Try a Trial
Patent: 20015781
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 210026
Estimated Expiration: ⤷ Try a Trial
Patent: 210027
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 21000999
Estimated Expiration: ⤷ Try a Trial
Patent: 21001547
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 10084
Estimated Expiration: ⤷ Try a Trial
Patent: 10581
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9464
Estimated Expiration: ⤷ Try a Trial
Patent: 9468
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 21528415
Estimated Expiration: ⤷ Try a Trial
Patent: 21528416
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 0200297
Estimated Expiration: ⤷ Try a Trial
Patent: 0200299
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 20013774
Estimated Expiration: ⤷ Try a Trial
Patent: 20013839
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 2000103
Estimated Expiration: ⤷ Try a Trial
Patent: 2000104
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 210136
Estimated Expiration: ⤷ Try a Trial
Patent: 210182
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 020552165
Estimated Expiration: ⤷ Try a Trial
Patent: 020552168
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202012151X
Estimated Expiration: ⤷ Try a Trial
Patent: 202012170P
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 210024032
Estimated Expiration: ⤷ Try a Trial
Patent: 210024033
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 23954
Estimated Expiration: ⤷ Try a Trial
Patent: 2012381
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BYLVAY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Colombia | 2020015781 | Modificaciones de cristales de odexibat | ⤷ Try a Trial |
Ecuador | SP21001547 | FORMULACIÓN FARMACÉUTICA DE ODEVIXIBAT | ⤷ Try a Trial |
Australia | 2019290338 | Pharmaceutical formulation of odevixibat | ⤷ Try a Trial |
Cyprus | 1118125 | ⤷ Try a Trial | |
Canada | 3100691 | MODIFICATIONS CRISTALLINES D'ODEVIXIBAT (CRYSTAL MODIFICATIONS OF ODEVIXIBAT) | ⤷ Try a Trial |
Mexico | 366925 | INHIBIDORES DE IBAT PARA EL TRATAMIENTO DE ENFERMEDADES HEPATICAS. (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES.) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2022101379 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYLVAY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3400944 | 2190043-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT; REG. NO/DATE: EU/1/21/1556 20210719 |
3400944 | 2021C/554 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719 |
3400944 | PA2021012,C3400944 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716 |
3400944 | PA2021012 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716 |
3400944 | 301157 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1566 20210719 |
3400944 | 2021054 | Norway | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT; REG. NO/DATE: EU/1/21/1566 20210805 |
3400944 | CA 2022 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |