BYLVAY Drug Patent Profile
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When do Bylvay patents expire, and what generic alternatives are available?
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 eleven 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: | 111 |
| 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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
IBAT inhibitors for the treatment of liver diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Crystal modifications of odevixibat
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
IBAT inhibitors for the treatment of liver disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-003 | Jul 20, 2021 | RX | Yes | Yes | ⤷ 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 | 215498-004 | Jul 20, 2021 | RX | Yes | Yes | ⤷ 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 | 215498-004 | 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 BYLVAY
| 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, 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 |
| Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-002 | Jul 20, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Patent: 19290338
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2020024461
Estimated Expiration: ⤷ Sign Up
Patent: 2020024479
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 00687
Estimated Expiration: ⤷ Sign Up
Patent: 00691
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 20003295
Estimated Expiration: ⤷ Sign Up
Patent: 20003296
Estimated Expiration: ⤷ Sign Up
China
Patent: 2262130
Estimated Expiration: ⤷ Sign Up
Patent: 2312893
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 20015772
Estimated Expiration: ⤷ Sign Up
Patent: 20015781
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 210026
Estimated Expiration: ⤷ Sign Up
Patent: 210027
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 21000999
Estimated Expiration: ⤷ Sign Up
Patent: 21001547
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10084
Estimated Expiration: ⤷ Sign Up
Patent: 10581
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9464
Estimated Expiration: ⤷ Sign Up
Patent: 9468
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 21528415
Estimated Expiration: ⤷ Sign Up
Patent: 21528416
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 0200297
Estimated Expiration: ⤷ Sign Up
Patent: 0200299
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 20013774
Estimated Expiration: ⤷ Sign Up
Patent: 20013839
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 2000103
Estimated Expiration: ⤷ Sign Up
Patent: 2000104
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 210136
Estimated Expiration: ⤷ Sign Up
Patent: 210182
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 020552165
Estimated Expiration: ⤷ Sign Up
Patent: 020552168
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202012151X
Estimated Expiration: ⤷ Sign Up
Patent: 202012170P
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 210024032
Estimated Expiration: ⤷ Sign Up
Patent: 210024033
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 23954
Estimated Expiration: ⤷ Sign Up
Patent: 2012381
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Chile | 2020003296 | ⤷ Sign Up | |
| China | 112312893 | ⤷ Sign Up | |
| Israel | 279464 | Pharmaceutical formulation of odevixibat | ⤷ Sign Up |
| Mexico | 2013005093 | INHIBIDORES DE IBAT PARA EL TRATAMIENTO DE ENFERMEADES HEPATICAS. (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES.) | ⤷ Sign Up |
| Japan | 3616635 | ⤷ Sign Up | |
| Norway | 2021054 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYLVAY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3400944 | C202130067 | Spain | ⤷ Sign Up | PRODUCT NAME: ODEVIXIBAT; NATIONAL AUTHORISATION NUMBER: EU/1/21/1566; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1566; DATE OF FIRST AUTHORISATION IN EEA: 20210716 |
| 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 | 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 | SPC/GB21/078 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ODEVIXIBAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING ODEVIXIBAT SESQUIHYDRATE; REGISTERED: UK EU/1/21/1566(NI) 20210719; UK PLGB 36216/0001 20210719; UK PLGB 36216/0002 20210719 |
| 3400944 | CR 2022 00001 | Denmark | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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