Details for New Drug Application (NDA): 220020

NDA 220020 describes YEZTUGO, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the YEZTUGO profile page.

The generic ingredient in YEZTUGO is lenacapavir sodium. One supplier is listed for this compound. Additional details are available on the lenacapavir sodium profile page.

Summary for 220020

Tradename:	YEZTUGO
Applicant:	Gilead Sciences Inc
Ingredient:	lenacapavir sodium
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 220020

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

TABLET;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.

Pharmacology for NDA: 220020

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A Inhibitors HIV Capsid Inhibitors P-Glycoprotein Inhibitors

Suppliers and Packaging for NDA: 220020

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
YEZTUGO	lenacapavir sodium	TABLET;ORAL	220020	NDA	Gilead Sciences, Inc.	61958-3401	61958-3401-1	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3401-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Jun 18, 2025	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 22, 2027
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Jun 18, 2028
Regulatory Exclusivity Use:	NEW PRODUCT
Patent:	10,071,985	Patent Expiration:	Aug 17, 2037	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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