LIVDELZI Drug Patent Profile

Name: LIVDELZI Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Livdelzi patents expire, and what generic alternatives are available?

Livdelzi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and thirty-eight patent family members in forty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Livdelzi

Livdelzi will be eligible for patent challenges on August 14, 2028. 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 August 14, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LIVDELZI

International Patents:	138
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	49
What excipients (inactive ingredients) are in LIVDELZI?	LIVDELZI excipients list
DailyMed Link:	LIVDELZI at DailyMed

Drug patent expirations by year for LIVDELZI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LIVDELZI

Generic Entry Date for LIVDELZI^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA NDA: 217899 Dosage: CAPSULE;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.

US Patents and Regulatory Information for LIVDELZI

LIVDELZI is protected by six US patents and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA.
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
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		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 LIVDELZI

When does loss-of-exclusivity occur for LIVDELZI?

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

Argentina

Patent: 8044
Estimated Expiration: ⤷ Start Trial

Australia

Patent: 06291006
Estimated Expiration: ⤷ Start Trial

Brazil

Patent: 0615835
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 22722
Estimated Expiration: ⤷ Start Trial

Cyprus

Patent: 16249
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 37065
Estimated Expiration: ⤷ Start Trial

Finland

Patent: 0253005
Estimated Expiration: ⤷ Start Trial

Guatemala

Patent: 0600420
Patent: SALES NOVEDOSAS DE LISINA DE DERIVADOS DE ACIDO 4-((FENOXIALQUIL)TIO)-FENOXIACETICO
Estimated Expiration: ⤷ Start Trial

Honduras

Patent: 06032171
Estimated Expiration: ⤷ Start Trial

Hong Kong

Patent: 22699
Patent: 苯氧基烷基硫代 -苯氧基乙酸衍生物的新型賴氨酸鹽 (NOVEL LYSINE SALTS OF 4-((PHENOXYALKYL) THIO)-PHENOXYACETIC ACID DERIVATIVES 4-(())-)
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 67770
Estimated Expiration: ⤷ Start Trial

Patent: 09514797
Estimated Expiration: ⤷ Start Trial

Jordan

Patent: 06
Patent: املاح ليسين مبتكرة من مشتقات حامض 4-((فينوكسي الكيل)ثيو) فينوكسي الخليك (Novel Lysine Salts of 4-((Phenoxy Alkyl)Thio)-Phenoxy Acetic Acid Derivatives)
Estimated Expiration: ⤷ Start Trial

New Zealand

Patent: 6504
Patent: Novel lysine salts of 4-(phenoxyalkyl) thio)-phenoxyacetic acid derivatives
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 080046695
Patent: NOVEL LYSINE SALTS OF 4-((PHENOXYALKYL)THIO)-PHENOXYACETIC ACID DERIVATIVES
Estimated Expiration: ⤷ Start Trial

Patent: 150013952
Patent: NOVEL LYSINE SALTS OF 4-((PHENOXYALKYL)THIO)-PHENOXYACETIC ACID DERIVATIVES
Estimated Expiration: ⤷ Start Trial

Patent: 160079129
Patent: 4-((페녹시알킬)티오)-페녹시아세트산 유도체의 신규한 리신염 (NOVEL LYSINE SALTS OF 4-((PHENOXYALKYL)THIO)-PHENOXYACETIC ACID DERIVATIVES)
Estimated Expiration: ⤷ Start Trial

Patent: 180079468
Patent: 4--페녹시아세트산 유도체의 신규한 리신염 (4-- NOVEL LYSINE SALTS OF 4-PHENOXYALKYLTHIO-PHENOXYACETIC ACID DERIVATIVES)
Estimated Expiration: ⤷ Start Trial

Taiwan

Patent: 0804256
Patent: Novel lysine salts of 4-((phenoxyalkyl)thio)-phenoxyacetic acid derivatives
Estimated Expiration: ⤷ Start Trial

Patent: 14510
Estimated Expiration: ⤷ Start Trial

Uruguay

Patent: 791
Patent: SALES NOVEDOSAS DE LISINA DE DERIVADOS DE ACIDO 4-( (FENOXIALQUIL)TIO)-FENOXIACETICO
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 LIVDELZI around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2015231232		⤷ Start Trial
Australia	2017274293		⤷ Start Trial
Brazil	112016020260		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LIVDELZI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3119384	C20253004	Finland	⤷ Start Trial
1937065	C20253005	Finland	⤷ Start Trial
1937065	CA 2025 00024	Denmark	⤷ Start Trial	PRODUCT NAME: L-LYSINSALT AF SELADELPAR, ISAER SELADELPAR-L-LYSIN-DIHYDRAT; REG. NO/DATE: EU/1/24/1898 20250221
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

DrugChatter Q&A for LIVDELZI

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