Details for New Drug Application (NDA): 217899

NDA 217899 describes LIVDELZI, which is a drug marketed by Cymabay and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the LIVDELZI profile page.

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.

Summary for 217899

Tradename:	LIVDELZI
Applicant:	Cymabay
Ingredient:	seladelpar lysine
Patents:	6

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 217899

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Suppliers and Packaging for NDA: 217899

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899	NDA	Gilead Sciences, Inc	61958-3301	61958-3301-1	30 CAPSULE in 1 BOTTLE (61958-3301-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 14, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 14, 2029
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:		Patent Expiration:	Mar 19, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent:		Patent Expiration:	Mar 19, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

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