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Last Updated: April 19, 2024

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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

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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
Drug patent expirations by year for BYLVAY
Drug Prices for BYLVAY

See drug prices for BYLVAY

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

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

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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.