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.
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
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.
| 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 | 9,040,518 | ⤷ 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
Estimated Expiration: ⤷ Start Trial
Australia
Patent: 11245393
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2012026767
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 95543
Estimated Expiration: ⤷ Start Trial
Chile
Patent: 12003009
Estimated Expiration: ⤷ Start Trial
China
Patent: 2858159
Estimated Expiration: ⤷ Start Trial
Colombia
Patent: 12267
Estimated Expiration: ⤷ Start Trial
Costa Rica
Patent: 120557
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
Estimated Expiration: ⤷ Start Trial
Eurasian Patent Organization
Patent: 1753
Estimated Expiration: ⤷ Start Trial
Patent: 1290909
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 63122
Estimated Expiration: ⤷ Start Trial
Hong Kong
Patent: 75650
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 29480
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 2365
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 02853
Estimated Expiration: ⤷ Start Trial
Patent: 13525444
Estimated Expiration: ⤷ Start Trial
Jordan
Patent: 31
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
Patent: 대사 장애를 치료 및 예방하기 위한 신규한 화합물 및 이를 포함하는 약학적 조성물 (NOVEL COMPOUNDS FOR THE TREATMENT AND PREVENTION OF METABOLIC DISORDERS AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME)
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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 081337 | ⤷ Start Trial | |
| Australia | 2011245393 | ⤷ Start Trial | |
| Brazil | 112012026767 | ⤷ Start Trial | |
| Canada | 2795543 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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