LIVDELZI Drug Patent Profile

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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 twenty-six patent family members in forty-two 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:	126
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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^: ⤷ Subscribe* 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 ⤷ Subscribe.

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.

Patents protecting LIVDELZI

Treatment of intrahepatic cholestatic diseases
Patent Number: 10,272,058
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Patent Number: 11,406,611
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Patent Number: 11,596,614
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Patent Number: 7,301,050
Patent Expiration: ⤷ Subscribe

Patent Number: 7,709,682
Patent Expiration: ⤷ Subscribe

Treatment of intrahepatic cholestatic diseases
Patent Number: 9,486,428
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

FDA Regulatory Exclusivity protecting LIVDELZI

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
Exclusivity Expiration: ⤷ Subscribe

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Subscribe

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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	11,596,614	⤷ Subscribe				⤷ Subscribe
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	9,486,428	⤷ Subscribe				⤷ Subscribe
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	11,406,611	⤷ Subscribe				⤷ Subscribe
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes	10,272,058	⤷ Subscribe				⤷ Subscribe
>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

See the table below for patents covering LIVDELZI around the world.

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Country	Patent Number	Title	Estimated Expiration
Peru	20070434		⤷ Subscribe
Slovenia	3463328		⤷ Subscribe
Russian Federation	2765460	ЛЕЧЕНИЕ ВНУТРИПЕЧЕНОЧНЫХ ХОЛЕСТАТИЧЕСКИХ ЗАБОЛЕВАНИЙ (TREATMENT OF INTRAHEPATIC CHOLESTATIC DISEASES)	⤷ Subscribe
Norway	341448		⤷ Subscribe
China	106102734	肝内胆汁淤积性疾病的治疗 (Treatment of intrahepatic cholestatic diseases)	⤷ Subscribe
Serbia	63345	SELADELPAR ZA LEČENJE PRIMARNOG BILIJARNOG HOLANGITISA (SELADELPAR FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration