LIVDELZI Drug Patent Profile

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.

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

Summary for LIVDELZI

US Patents:	6
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LIVDELZI

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

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.

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
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes

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:

Cyprus

Finland

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.

Country	Patent Number	Title	Estimated Expiration
Australia	2015231232
Australia	2017274293
Brazil	112016020260
Brazil	112018074147
Canada	2941401
Canada	3024155

Supplementary Protection Certificates for LIVDELZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3119384	202540028	Slovenia		PRODUCT NAME: SELADELPAR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR SELADELPAR L-LYSINE DIHYDRATE; NATIONAL AUTHORISATION NUMBER: EU/1/24/1898; DATE OF NATIONAL AUTHORISATION: 20250220; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3119384	CR 2025 00025	Denmark		PRODUCT NAME: SELADELPAR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER SELADELPAR-L-LYSIN-DIHYDRAT; REG. NO/DATE: EU/1/24/1898 20250221
3119384	2025C/532	Belgium		PRODUCT NAME: SELADELPAR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER SELADELPAR L-LYSINEDIHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/24/1898 20250221
1937065	C20253005	Finland
3119384	26/2025	Austria		PRODUCT NAME: SELADELPAR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE SELADELPAR-L-LYSIN-DIHYDRAT; REGISTRATION NO/DATE: EU/1/24/1898 (MITTEILUNG) 20250221
3119384	CA 2025 00025	Denmark		PRODUCT NAME: SELADELPAR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER SELADELPAR-L-LYSIN-DIHYDRAT; REG. NO/DATE: EU/1/24/1898 20250221