LYNAVOY Drug Patent Profile

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When do Lynavoy patents expire, and when can generic versions of Lynavoy launch?

Lynavoy is a drug marketed by Intercept and is included in one NDA. There is one patent protecting this drug.

This drug has forty-two patent family members in thirty-nine countries.

The generic ingredient in LYNAVOY is linerixibat. One supplier is listed for this compound. Additional details are available on the linerixibat profile page.

DrugPatentWatch^® Generic Entry Outlook for Lynavoy

Lynavoy will be eligible for patent challenges on March 17, 2030. 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 March 17, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LYNAVOY

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LYNAVOY

LYNAVOY is protected by one US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LYNAVOY is ⤷ Start Trial.

This potential generic entry date is based on TREATMENT OF CHOLESTATIC PRURITUS ASSOCIATED WITH PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULT PATIENTS.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intercept	LYNAVOY	linerixibat	TABLET;ORAL	220295-001	Mar 17, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Intercept	LYNAVOY	linerixibat	TABLET;ORAL	220295-001	Mar 17, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Intercept	LYNAVOY	linerixibat	TABLET;ORAL	220295-001	Mar 17, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for LYNAVOY

When does loss-of-exclusivity occur for LYNAVOY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1337
Patent: DERIVADOS DE 1,4-BENZOTIAZEPINAS, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y SU USO EN LA PREPARACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE TRASTORNOS METABOLICOS
Estimated Expiration: ⤷ Start Trial

Australia

Patent: 11245393
Estimated Expiration: ⤷ Start Trial

Brazil

Patent: 2012026767
Patent: composto, sal farmaceuticamente aceitável de um composto, composição farmacêutica, método para tratar ou previnir distúrbios, e, uso de um composto ou sal
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 95543
Patent: COMPOSES CHIMIQUES (CHEMICAL COMPOUNDS)
Estimated Expiration: ⤷ Start Trial

Chile

Patent: 12003009
Patent: Acido3-(((3-butil-3-etil-(metiloxi)-1-1-dioxido-5-fenil-2,3,4,5-tetrahidro-1,4benxotiazepin-8-il)-metil)-amino)-pentanodioco; composicion farmaceutica que lo comprende; y su uso en un tastorno metabolico. pct.
Estimated Expiration: ⤷ Start Trial

China

Patent: 2858159
Patent: Chemical compounds
Estimated Expiration: ⤷ Start Trial

Colombia

Patent: 12267
Patent: Nuevos derivados de 1,1 dióxido- 5 fenil- 2,3,4-5tetrahidro- 1,4-benzotiazepina y composiciones farmaceúticas que los comprenden
Estimated Expiration: ⤷ Start Trial

Costa Rica

Patent: 120557
Patent: COMPUESTOS QUÍMICOS
Estimated Expiration: ⤷ Start Trial

Croatia

Patent: 0161103
Estimated Expiration: ⤷ Start Trial

Cyprus

Patent: 18187
Estimated Expiration: ⤷ Start Trial

Denmark

Patent: 63122
Estimated Expiration: ⤷ Start Trial

Dominican Republic

Patent: 012000263
Patent: COMPUESTOS QUIMICOS
Estimated Expiration: ⤷ Start Trial

Eurasian Patent Organization

Patent: 1753
Patent: ХИМИЧЕСКИЕ СОЕДИНЕНИЯ (3-({[3-BUTYL-3-ETHYL-7-(METHYLOXY)-1,1-DIOXIDO-5-PHENYL-2,3,4,5-TETRAHYDRO-1,4-BENZOTHIAZEPINE-8-YL]METHYL}AMINO)PENTANEDIOIC ACID)
Estimated Expiration: ⤷ Start Trial

Patent: 1290909
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 63122
Patent: COMPOSÉS CHIMIQUES (CHEMICAL COMPOUNDS)
Estimated Expiration: ⤷ Start Trial

Hong Kong

Patent: 75650
Patent: 化合物 (CHEMICAL COMPOUNDS)
Estimated Expiration: ⤷ Start Trial

Hungary

Patent: 29480
Estimated Expiration: ⤷ Start Trial

Israel

Patent: 2365
Patent: 2,2'–({[3–בוטיל–3–אתיל–7–(מתילאוקסי)–1,1–דיאוקסידו–5–פניל–5,4,3,2–טטרה הידרו– 1, 4– בנזותיאזפינ–8–איל] מתיל} אימינו) די חומצה אצטית (2,2'-({[3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,4-benzothiazepin-8-yl]methyl}imino)diacetic acid)
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 02853
Estimated Expiration: ⤷ Start Trial

Patent: 13525444
Patent: 化合物
Estimated Expiration: ⤷ Start Trial

Jordan

Patent: 31
Patent: مركبات كيميائية (Chemical Compounds)
Estimated Expiration: ⤷ Start Trial

Lithuania

Patent: 63122
Estimated Expiration: ⤷ Start Trial

Malaysia

Patent: 2933
Patent: CHEMICAL COMPOUNDS
Estimated Expiration: ⤷ Start Trial

Mexico

Patent: 12012527
Patent: COMPUESTOS QUIMICOS. (CHEMICAL COMPOUNDS.)
Estimated Expiration: ⤷ Start Trial

Montenegro

Patent: 490
Patent: HEMIJSKA JEDINJENJA (CHEMICAL COMPOUNDS)
Estimated Expiration: ⤷ Start Trial

Morocco

Patent: 235
Patent: COMPOSES CHIMIQUES
Estimated Expiration: ⤷ Start Trial

New Zealand

Patent: 2754
Patent: Substituted 1,3-benzothiazepines useful in treating metabolic disorders
Estimated Expiration: ⤷ Start Trial

Peru

Patent: 130384
Patent: DERIVADOS DE BENZOTIAZEPINA
Estimated Expiration: ⤷ Start Trial

Philippines

Patent: 012502128
Patent: CHEMICAL COMPOUNDS
Estimated Expiration: ⤷ Start Trial

Poland

Patent: 63122
Estimated Expiration: ⤷ Start Trial

Portugal

Patent: 63122
Estimated Expiration: ⤷ Start Trial

San Marino

Patent: 01600293
Patent: COMPOSTI CHIMICI
Estimated Expiration: ⤷ Start Trial

Serbia

Patent: 079
Patent: HEMIJSKA JEDINJENJA (CHEMICAL COMPOUNDS)
Estimated Expiration: ⤷ Start Trial

Singapore

Patent: 4812
Patent: CHEMICAL COMPOUNDS
Estimated Expiration: ⤷ Start Trial

Slovenia

Patent: 63122
Estimated Expiration: ⤷ Start Trial

South Africa

Patent: 1207858
Patent: CHEMICAL COMPOUNDS
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 1769079
Estimated Expiration: ⤷ Start Trial

Patent: 130060201
Estimated Expiration: ⤷ Start Trial

Spain

Patent: 88743
Estimated Expiration: ⤷ Start Trial

Ukraine

Patent: 0338
Patent: CHEMICAL COMPOUNDS
Estimated Expiration: ⤷ Start Trial

Uruguay

Patent: 353
Patent: COMPUESTOS ADECUADOS PARA EL TRATAMIENTO DE TRASTORNOS METABOLICOS Y METODOS DE PREPARACION
Estimated Expiration: ⤷ Start 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 LYNAVOY around the world.

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Country	Patent Number	Title	Estimated Expiration
Argentina	081337	DERIVADOS DE 1,4-BENZOTIAZEPINAS, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y SU USO EN LA PREPARACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE TRASTORNOS METABOLICOS	⤷ Start Trial
Australia	2011245393		⤷ Start Trial
Brazil	112012026767	composto, sal farmaceuticamente aceitável de um composto, composição farmacêutica, método para tratar ou previnir distúrbios, e, uso de um composto ou sal	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

AI Deep Research

Questions you can ask:

Summary for LYNAVOY

When does loss-of-exclusivity occur for LYNAVOY?

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